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Study Objectives
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Gedatolisib, DRUG: Palbociclib, DRUG: Letrozole, DRUG: Fulvestrant
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Women 18 years or older, who are either: Postmenopausal or Pre/perimenopausal women with medically-induced menopause by treatment with agents to induce chemical menopause.
* Histologically or cytologically proven diagnosis of breast cancer with evidence of metastasis.
* Documentation of estrogen receptor positive ((ER+), human epidermal growth factor receptor 2 (HER2 negative (HER2-)) tumor.
* Dose Escalation Portion: Patients must satisfy one of the following criteria:
* Letrozole combination cohort (L): metastatic breast cancer (MBC) with progression who are candidates for a letrozole-containing regimen, with palbociclib.
* Fulvestrant combination cohort (F): MBC with progression who are candidates for a fulvestrant containing regimen, with palbociclib.
* Dose Expansion Portion: Patients must satisfy one of the following criteria:
* Arm A: MBC with progression and no prior endocrine based systemic therapy in the metastatic setting;
* Arm B: MBC with progression during or following one prior endocrine based systemic therapy in the metastatic setting, with no prior therapy with any cyclin-dependent kinase (CDK) inhibitor;
* Arm C/Arm D: MBC with progression during or following one or two prior endocrine based systemic therapies in the metastatic setting, and following prior therapy with a CDK inhibitor.
* Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
* Bone only patients during dose escalation portion.
* Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.
* Eastern Cooperative Oncology Group [ECOG] performance must be 0 or 1.
* Adequate bone marrow, renal and liver function.
Exclusion Criteria:
* Prior treatment with a mechanistic target of rapamycin (mTOR) inhibitor or phosphoinositide 3-kinase (PI3K) inhibitor.
* More than 1 line of prior chemotherapy in the treatment of metastatic or locally advanced/recurrent disease.
* Bone only patients during expansion/efficacy portion.
* Patients with advanced/metastatic disease who have symptomatic visceral spread, and who have life threatening complications needing immediate therapy, such as massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver replacement with tumor.
* Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases.
* Active bacterial, fungal or viral infection.
* Uncontrolled or significant cardiovascular disease.
* Radiation therapy within 4 weeks of investigational product.
* Cytotoxic chemotherapy within 4 weeks of investigational product (6 weeks for mitomycin C or nitrosoureas) if immediate prior regimen was administered on an every 3 4 week schedule or 2 weeks of investigational product if immediate prior regimen consisted of weekly therapy.
* Any other anti cancer agents (eg, hormonal, biological, investigational) within 5 times the half life prior to investigational product.
* Impairment of gastro intestinal (GI) function or GI disease.
* Pregnant female patients; breastfeeding female patients; and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for 90 days.
|
NCT_ID
NCT02684032
|
Study_NameA Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer
| 15,274 |
Study Objectives
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib \[TARCEVA®\]), gemcitabine or vinorelbine (NAVELBINE®)
Conditions: Non - Small Cell Lung Cancer NSCLC
Intervention / Treatment:
DRUG: MEDI4736 (durvalumab), DRUG: Vinorelbine, DRUG: Gemcitabine, DRUG: Erlotinib, DRUG: MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4), DRUG: tremelimumab (anti-CTLA4)
Location: Poland, Thailand, United Kingdom, Australia, France, Korea, Republic of, Chile, Singapore, Netherlands, Greece, Canada, Germany, Spain, Czechia, Italy, Taiwan, Romania, Hong Kong, Israel, United States, Japan, Bulgaria, Belgium, Serbia, Russian Federation, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Aged at least 18 years
* Documented evidence of NSCLC (Stage IIIB/ IV disease)
* Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC
* World Health Organization (WHO) Performance Status of 0 or 1
* Estimated life expectancy more than 12 weeks
Exclusion Criteria:
* Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4
* Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
* Active or prior documented autoimmune disease within the past 2 years
* Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV
* Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy
* Known EGFR TK activating mutations or ALK rearrangements
* Any prior Grade >=3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
* Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
|
NCT_ID
NCT02352948
|
Study_NameA Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
| 724 |
Study Objectives
The purpose of this study is to determine whether 5-Azacytidine priming before the conditioning regimen for subjects receiving a hematopoietic stem cell transplant is an effective treatment for high risk myeloid malignancies in complete remission (CR).
Conditions: Leukemia, Erythroblastic, Acute, Myelodysplastic Syndromes
Intervention / Treatment:
DRUG: 5-Azacytidine, DRUG: Fludarabine, DRUG: Melphalan, DRUG: Alemtuzumab, RADIATION: Total Body Irradiation
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) as specified below:
1. Acute myeloid leukemia with poor risk cytogenetics in complete morphologic remission. These include: del (5q)/-5, del (7q)/-7, abn 3q, 9q, 11q, 20q, 21q, 17p, t(6;9), t(9;22) or complex karyotypes (>= 3 unrelated abnormalities); or
2. Acute myeloid leukemia with either Flt-3, TET-2, p53, DNMT3A, or ASXL1 mutation, mutations of genes involved in the chromatin/spliceosome category (EZH2, SRSF2, U2AF1, ZRSR2), BCOR, and RUNX1, as well as MLL rearrangement, EVI1 overexpression in complete morphologic remission; or
3. Acute myeloid leukemia with a white blood cell count of greater than or equal to 50,000/mcL at presentation in first complete morphologic remission; or
4. Acute myeloid leukemia in first complete morphologic remission, having required more than one course of induction chemotherapy to attain remission status; or
5. Acute myeloid leukemia, all types, excluding M3 (Promyelocytic leukemia) in second or higher complete morphologic remission; or
6. Myelodysplastic syndromes (intermediate-2, high risk and chronic myelomonocytic leukemia (CMML) with bone marrow blasts <5%); or
7. Secondary acute myeloid leukemia on the basis of prior MDS or prior myeloproliferative neoplasm (MPN) in complete morphologic remission
* Life expectancy not severely limited by concomitant disease
* Karnofsky Performance Score greater than or equal to 70%.
* Adequate organ function as defined below:
Serum Bilirubin:<2.0 mg/dL; Alanine Aminotransferase (ALT) (SGPT): <3 x upper limit of normal; Creatinine Clearance:>60 mL/min (eGFR as estimated by the modified Modification of Diet in Renal Disease Study (MDRD) equation)
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Evidence of chronic active hepatitis or cirrhosis
* HIV infection
* Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
* There are no prior therapies or concomitant medications that would render the patients ineligible
|
NCT_ID
NCT02497404
|
Study_NameAzacytidine Prior to in Vivo T-cell Depleted Allo Stem Cell Transplant for Patients With Myeloid Malignancies in CR
| 6,187 |
Study Objectives
This is a feasibility study that aims to evaluate whether PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) is a safe and feasible treatment in Danish patients with peritoneal cancer.
Conditions: Peritoneal Carcinomatosis
Intervention / Treatment:
DRUG: PIPAC
Location: Denmark
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion criteria
* Histological or cytological verified malignancy.
* Clinical or radiological evidence of peritoneal carcinomatosis.
* No indication for standard chemotherapy.
* Performance status 0 <= age <= 2 and life expectancy of more than 3 months.
* Age > 18 years.
* Written informed consent must be obtained according to the local Ethics Committee requirements.
Exclusion criteria
* Symptomatic small bowel obstruction (Total parenteral nutrition, nasogastric tube).
* Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
* A history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin.
* Renal impairment, defined as GFR < 50 ml/min, (Cockcroft-Gault Equation).
* Myocardial insufficiency, defined as NYHA class > 2.
* Impaired liver function defined as bilirubin >= 1,5 x UNL (upper normal limit).
* Inadequate haematological function defined as ANC <= 1.5 x 109/l and platelets <= 100 x 109/l.
* Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
* Previous intraabdominal chemotherapy or intraabdominal antibody therapy.
|
NCT_ID
NCT02320448
|
Study_NameTreating Peritoneal Carcinomatosis With PIPAC
| 14,633 |
Study Objectives
This is a Phase I, randomized, double-blind, placebo-controlled, study to estimate the effects of daily oral dosing of 800 mg pazopanib on electrocardiographic parameters (QTc interval duration) as compared with placebo in subjects with solid tumors. Moxifloxacin, will serve as a positive control.
Conditions: Carcinoma, Renal Cell
Intervention / Treatment:
DRUG: Pazopanib, OTHER: Placebo for pazopanib, DRUG: Moxifloxacin, OTHER: Placebo for moxifloxacin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Male or female, age >= 18 years, at the time of signing of the informed consent.
* Has histologically or cytologically confirmed advanced solid tumor malignancy.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Able to swallow and retain oral medication.
* Adequate organ systems function.
* Serum potassium level >4 mEq/L, magnesium level >1.7 mg/dL and total serum calcium level within normal limits (if albumin is <4.5 g/dL, albumin-corrected total serum calcium level should be within normal limits [see Appendix 7]). NOTE: Supplementation is permitted in order to meet this criterion. Subject should be retested following supplementation.
* Subject is a woman of non-childbearing potential or willing to use acceptable contraception.
* Subject is a man with a female partner of childbearing potential agrees to use contraception.
* Subject, if sexually active, agrees to continue the recommended contraception method for the duration of treatment and for 28 days following discontinuation of treatment.
* Capable of giving written informed consent.
* The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Exclusion Criteria:
* Any of the following ECG findings, QTcF interval >470 msec, PR interval >240 msec or <=110msec, Bradycardia defined as sinus rate <50 beats per minute
* Cardiac conduction abnormalities denoted by any of the following: Evidence of second-degree (type II) or third-degree atrioventricular block, Evidence of ventricular pre-excitation, Electrocardiographic evidence of complete left bundle branch block (LBBB), Intraventricular conduction delay with QRS duration >120 msec, Atrial fibrillation, Presence of cardiac pacemaker.
* History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease or other clinically significant cardiac disease.
* For subjects with a history of myocardial infarction (>6 months ago), congestive heart failure (>6 months ago) or prior anthracycline exposure, left ventricular ejection fraction (LVEF) must be assessed within 28 days prior to the first dose of study drug by one of the following methods: multiple gated acquisition (MUGA) scan or echocardiogram (ECHO). Subjects with a measurement of LVEF <50% are excluded from participation in the study.
* Personal or family history of long-QT syndrome.
* History or clinical evidence of CNS metastases or leptomeningeal carcinomatosis, except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 2 months prior to beginning study treatment.
* Clinically significant gastrointestinal (GI) abnormalities that may affect the absorption of study drug including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel.
* Clinically significant GI abnormalities that may increase the risk for GI bleeding including, but not limited to: active peptic ulcer disease, known intra-luminal metastatic lesion(s) with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI conditions with increased risk of perforation, history of abdominal fistula, GI perforation or intra-abdominal abscess within 28 days prior to beginning study treatment.
* Presence of uncontrolled infection.
* Unable or unwilling to discontinue use of prohibited medications listed in Section 9.2 for at least 14 days prior to the first dose of study drug (see Section 9.2).
* Poorly controlled hypertension [systolic blood pressure (SBP) >140 mmHg, or diastolic blood pressure (DBP) >90 mmHg].
* History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
* Evidence of active bleeding or bleeding diathesis.
* Hemoptysis within 6 weeks prior to the first dose of study drug.
* Known endobronchial lesion(s) or involvement of large pulmonary vessel(s) by tumor.
* History of sensitivity or allergic reaction to moxifloxacin or any member of the quinolone class of antimicrobial agents.
* Treatment with anti-cancer therapy (including chemotherapy, radiation therapy, immunotherapy, biologic therapy, investigational therapy, hormonal therapy, surgery or tumor embolization) within 14 days prior to the first dose of pazopanib.
* History or presence of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* Prior major surgery or trauma within the past 28 days prior to the first dose of study drug and/or presence of any non-healing wound, fracture or ulcer.
* Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study.
|
NCT_ID
NCT00861029
|
Study_NameVEG111485: A QTc Study of Pazopanib
| 4,932 |
Study Objectives
This partially randomized phase I trial studies the side effects and how well sequential dosing of vascular endothelial growth factor receptor (VEGFR)/platelet derived growth factor receptor (PDGFR) dual kinase inhibitor X-82 and docetaxel works in treating patients with solid tumors. VEGFR/PDGFR dual kinase inhibitor X-82 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving VEGFR/PDGFR dual kinase inhibitor X-82 and docetaxel one at a time instead of concurrently may work in treating patients with solid tumors.
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: VEGFR/PDGFR dual kinase inhibitor X-82, DRUG: docetaxel, OTHER: fluorine F 18 fluorothymidine, PROCEDURE: positron emission tomography/computed tomography, OTHER: pharmacological study, OTHER: laboratory biomarker analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* For the pharmacodynamic (PD) cohort, patients must have histologically or cytologically confirmed solid malignancy (excluding lymphoma) that is metastatic or unresectable; all patients will need to be approved by the principal investigator [PI] as certain diseases may not be appropriate for the imaging assessments)
* For the dose expansion cohort, patients with histologically or cytologically confirmed solid malignancy are eligible for treatment as long as insurance approval for docetaxel is obtained.
* Patients must have no available therapies that will confer clinical benefit and docetaxel is a reasonable treatment option for their malignancy
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 2 times the slice width with spiral CT scan (i.e. 10 mm if the CT slice width is 5 mm, 14 mm if the CT slice width is 7 mm)
* Life expectancy of greater than 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
* Leukocytes >= 3,000/mcL
* Absolute neutrophil count >= 1,500/mcL
* Platelets >= 100,000/mcL
* Hemoglobin >= 9 g/dL
* Serum calcium =< 12.0 mg/dL
* Total serum bilirubin =< institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
* Creatinine =< 1.5 mg/dL OR creatinine clearance (measured) >= 50 mL/min
* Urinary protein =< 2+ by urine analysis; if urine protein is > 2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is < 2 g per 24 hours
* All patients need to be willing to undergo planned pharmacodynamic assessments, including serial PET imaging and pharmacokinetic sampling
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; all women of childbearing potential must have a negative pregnancy test prior to receiving X-82; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients who have had chemotherapy, radiotherapy, experimental therapy or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered (to grade =< 1 or baseline) from clinically significant adverse events due to agents administered more than 4 weeks earlier (alopecia and fatigue excluded); clinical significance to be determined by investigator
* Patients may not be receiving any other investigational agents
* Prior anti-VEGF directed therapy may be allowed only if approved by the PI
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to X-82 or docetaxel
* Patients with poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher) are ineligible; patients with a history of hypertension (HTN) and stable blood pressure (BP) < 140/90 on anti-HTN regimen are eligible
* Patients will be required to have a baseline electrocardiogram (EKG) prior to the start of treatment; patients with a corrected QT (QTc) > 480 millisecond (ms) are excluded from the study
* Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain X-82 tablets are excluded
* Patients with any of the following conditions are excluded:
* Serious or non-healing wound, ulcer, or bone fracture
* History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days of treatment
* Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry
* History of myocardial infarction, ventricular arrhythmia, stable/unstable angina, symptomatic congestive heart failure, coronary/peripheral artery bypass graft or stenting or other significant cardiac disease within 12 months prior to study entry
* Any history of arterial or venous thrombosis/thromboembolic event, including pulmonary embolism within the past 12 months
* Any episode of atrial fibrillation in the prior 12 months
* Patients without appropriate lesion on CT scan for fluorothymidine (FLT)-PET/CT imaging will be excluded
* The eligibility of patients taking medications that are potent inducers or inhibitors of the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) liver enzyme will be determined following a review of their case by the principal investigator; every effort should be made to switch patients taking such agents or substances to other medications; any identified agent needs to be stopped at least 2 weeks prior to study registration
* Patients with known brain metastases should be excluded; patients who had definitive treatment for their brain metastases which includes surgical resection/stereotactic body radiation therapy (SBRT) with whole brain radiation therapy (WBRT) > 6 months ago will be eligible
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements are ineligible
* Pregnant women are excluded from this study; breastfeeding should be discontinued prior to starting study treatment
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
* Patients taking herbal supplements (St. John's Wort, gingko balboa, etc.) should discontinue these supplements two weeks prior to study registration
* Patients cannot be receiving concomitant chemotherapy, radiotherapy, experimental therapy or any other therapy for the purposes of anti-cancer treatment
* Subjects must not have clinically significant bleeding (i.e. GI bleed, intracranial bleeding) whtin 6 months or have had major surgery within 4 weeks. Minor surgeries (i.e. port placement, cataract surgery) are allowed if completed more than within 2 weeks from the start of treatment.
* Any brain metastases must be stable and not progressing prior to study entry
* Patients with prior malignancy except for the following:
* Adequately treated basal cell or squamous cell skin cancer
* In situ cervical cancer
* Adequately treated Stage I or II cancer from which the patient is currently in complete remission and has been disease free for the past 2 years
* Any other cancer from which the patient has been disease-free for 5 years
|
NCT_ID
NCT02146222
|
Study_NameVEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
| 2,805 |
Study Objectives
This is a prospective open-labeled phase I trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the Maximum Tolerated Dose (MTD) is established.
Conditions: Solid Tumor, Osteosarcoma
Intervention / Treatment:
DRUG: Sirolimus combined with CP, MT and ZA
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histology:
* Advanced solid tumor with radiologically proven bone metastasis, (dose escalation part)
* Patients with osteogenic osteosarcoma (dose escalation part and expansion cohort) histologically confirmed by central review
* Metastatic or unresectable locally advanced disease, not eligible for alternative local treatment (radiotherapy for instance)
* Age > 18 years for patients with solid tumor and >= 13 years for patients with osteosarcoma
* ECOG, performance status <= 1
* Life expectancy > 3 months
* Measurable disease according to RECIST v1.1. At least one site of disease must be uni-dimensionally >= 10 mm
* Patients must have histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors, which are not amenable to standard treatment, including for patients with osteosarcoma conventional agents such as anthracyclines, platinum salts, ifosfamide and/or methotrexate
* At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and/or radiotherapy
* Adequate haematological, renal, metabolic and hepatic function:
* Haemoglobin >= 10 g/dl (patients may have received prior red blood cell transfusion, if clinically indicated); leucocytes >= 3 x 10^9/l, absolute neutrophil count >= 1.5 x 10^9/l, and platelet count >= 120 x 10^9/l.
* Alanine aminotransferase and aspartate aminotransferase <= 2.5 x upper limit of normality (ULN)
* Total bilirubin <= 1.5 x ULN
* Calculated creatinine clearance > 40 ml/min/1.73 m² (according to MDRD formula)
* Creatine phosphokinase <= 2.5 x ULN
* Albumin > 25 g/l
* No prior or concurrent malignant disease diagnosed or treated in the last 2 years except adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
* Recovery to grade <= 1 from any adverse event derived from previous treatment (excluding alopecia of any grade and non-painful peripheral neuropathy grade <= 2) according to the NCI-CTCAE, version 4
* Patients with a French social security in compliance with the French law relating to biomedical research
* Voluntarily signed and dated written informed consent prior to any study specific procedure
* Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six months after discontinuation of treatment
Exclusion Criteria:
* Previous treatment with sirolimus
* Concomitant diseases/conditions:
* Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions
* Unstable cardiac disease, pulse oximetry saturation < 90% at rest
* Clinically significant immunodeficiency, such as HIV or active Hepatitis B or C
* History of auto-immune disease, transplantation
* Central nervous system malignancy
* Men or women of childbearing potential who are not using an effective method of contraception; women who are pregnant or breast feeding
* Patients receiving any substances that are inhibitors or inducers of CYP450 3A4
* Ongoing or recent (<6 weeks) dental problem, including any severe tooth or jaw infection (mandible and maxilla), dental trauma, dental or stomatological surgery (implants). Current dental cares are allowed
* History of maxillary osteonecrosis or delayed healing after dental surgery
* Participation to a study involving a medical or therapeutic intervention in the last 30 days
* Previous enrolment in the present study
* Patient unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons
* Known hypersensitivity to any involved study drug or any of its formulation components
* Patients receiving live vaccines within 30 days prior to the first dose of study therapy and while participating in study
|
NCT_ID
NCT02517918
|
Study_NameMetronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma
| 7,466 |
Study Objectives
The purpose of this study is to investigate the side effects and safety, and effectiveness of combining dabrafenib and trametinib with radiotherapy.
Previous and ongoing clinical trials have demonstrated the effectiveness and safety of combining both dabrafenib and trametinib compared with dabrafenib alone. This has led to the approval for the use of both drugs in combination in people with metastatic melanoma with the BRAF mutation. Melanoma that has spread to other parts of the body may also benefit from radiotherapy to help reduce symptoms from melanoma. Previous studies have shown that melanoma may be sensitive to radiotherapy and that it can help to improve quality of life.
The intention of the CombiRT study is to establish if dabrafenib, trametinib and radiotherapy combined is a safe and effective treatment for metastatic melanoma.
Conditions: Metastatic Melanoma
Intervention / Treatment:
RADIATION: Palliative radiotherapy, DRUG: Dabrafenib and trametinib (combination)
Location: Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* >=18 years.
* Signed written informed consent.
* Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive as determined by a BRAF mutation assay.
Note: For Stage IIIC disease, the decision that the disease is unresectable should be formally endorsed by the melanoma multidisciplinary tumour board of the local institution.
* Have received dabrafenib and trametinib for 2 weeks or more prior to enrolment in the study (i.e. first fraction of palliative RT), and is still continuing with dabrafenib and trametinib.
* Symptomatic or bulky (greater than 2 cm in diameter) soft tissue, nodal or bony metastases requiring palliative RT.
* Have measurable disease according to RECIST 1.1 criteria. Note: patients with bony metastases that are not measurable by RECIST 1.1 criteria are allowed in this study.
* All anti-cancer treatment-related toxicities (except alopecia and laboratory values as listed on Table 1 in protocol) must be less than or equal to (<=) Grade 1 according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.03; NCI, 2009) at the time of study enrolment.
* Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrolment and agree to use effective contraception, from 14 days prior to enrolment throughout the treatment period, and for 4 months after the last dose of study treatment.
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate baseline organ function (as defined in Table 1 in protocol).
Exclusion Criteria:
* Treatment with Ipilimumab or any other anti-CTLA-4 monoclonal antibody therapy within the past 4 weeks.
* Treatment with anti-PD-1 or anti-PD-L1 monoclonal antibody therapy within the past 4 weeks.
* Known ocular or primary mucosal melanoma.
* Four (4) or more lesions requiring palliative RT at the time of study enrolment.
* Symptomatic brain metastases or those treated < 3 months previously.
* Clear evidence of systemic disease progression on dabrafenib and trametinib.
* Systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) within the last 4 weeks. Prior interferon treatment in the adjuvant setting is allowed.
Note: Tamoxifen and aromatase inhibitors are allowed in the adjuvant setting of breast cancer.
* Current use of a prohibited medication (list of prohibited medications in protocol).
* History of malignancy other than disease under study within 3 years of study enrolment with exceptions below, or any malignancy with confirmed activating RAS mutation.
Note: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility.
Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer.
* Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.
* A history of known Human Immunodeficiency Virus (HIV).
* A history or evidence of cardiovascular risk including any of the following:
* A QT interval corrected for heart rate using the Bazett's formula (QTcB) >= 480 msec;
* A history or evidence of current clinically significant uncontrolled arrhythmias;
* A history of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months prior to enrolment;
* A history or evidence of current >= Class II congestive heart failure as defined by the New York Heart Association (NYHA) guidelines;
* Patients with intra-cardiac defibrillators;
* Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study; g. Treatment refractory hypertension defined as a blood pressure of systolic> 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy; h. Known cardiac metastases.
* A history of retinal vein occlusion (RVO).
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO).
* Pregnant or nursing females.
* Previous RT to the same lesion or area due to receive the current course of palliative RT.
Note: patients who had previous RT to other areas are eligible to the study if the previous RT was completed more than 8 weeks prior.
* A history of autoimmune diseases which are known to increase radiation toxicity, including systemic lupus erythematosus and scleroderma.
* Genetic syndromes exhibiting increased radiosensitivity (e.g. ataxia telangiectasia).
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NCT_ID
NCT02392871
|
Study_NameRadiotherapy & Combi in Metastatic Melanoma
| 20,781 |
Study Objectives
The goal of this clinical research study is to learn if Revlimid (lenalidomide) can help to reduce the level of leukemia in your body. The safety of this drug will also be studied.
Conditions: Chronic Lymphocytic Leukemia
Intervention / Treatment:
DRUG: Lenalidomide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients should have completed their chemotherapy 3 months prior to start of treatment with lenalidomide and not more than 9 months prior to treatment initiation.
* Patients with CLL/Small Lymphocytic Lymphoma (SLL) that achieve a complete or stable partial remission after combination of chemotherapy. Patients in complete remission need to have documentation of residual disease by immunophenotyping and/or PCR molecular testing.
* Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) status of 0 <= age <= 2.
* Adequate renal and hepatic function (creatinine equal to or less than 2mg/dL - total bilirubin equal to or less than 2).
* Females of childbearing potential (FCBP). A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; 2) or has not been naturally postmenopausal for at least 24 consecutive months (has NOT had menses at any time in the preceding 24 consecutive months).
* FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 <= age <= 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control; one highly effective and one additional effective method AT THE SAME TIME at least 28 days before starting taking lenalidomide.
* FCBP must also agree to ongoing pregnancy testing weekly for the first four weeks and then every 28 days while on therapy and at discontinuation of treatment.
* Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
* Age 18 and older.
* Signed, written IRB-approved informed consent.
Exclusion Criteria:
* Known sensitivity to lenalidomide or thalidomide or it's derivatives
* Known positivity for HIV or active hepatitis B or C.
* Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
* History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Use of any other experimental drug or therapy within 28 days of baseline.
* Concurrent use of other anti-cancer agents or treatments
|
NCT_ID
NCT00632359
|
Study_NameLenalidomide in Chronic Lymphocytic Leukemia (CLL) Patients With Residual Disease
| 11,941 |
Study Objectives
The purpose of this study is to evaluate the safety and tolerability and describe the maximum tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with bevacizumab and paclitaxel for patients with advanced solid tumors.
Conditions: SOLID TUMORS
Intervention / Treatment:
DRUG: Sorafenib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histological or cytological diagnosis of a solid tumor with evidence of residual, recurrent, or metastatic disease. Patients must be incurable by surgical or other standard available therapy
* Measurable or evaluable disease; tumor size of >= 2 cm on CT scan
* Patients may have received prior standard taxane therapy or anti-VEGF therapy, but may not have progressed on both therapies. Progression on one type therapy (either taxane or anti-VEGF) is allowed
Exclusion Criteria:
* History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
* Prior chemotherapy <= 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
* Prior biologic or immunotherapy <= 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
* Prior full pelvic field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks prior to randomization. Patients must have recovered to less than or equal to grade 1 from all therapy-related toxicities except alopecia. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of evaluable disease
* Major surgery (i.e., laparotomy) <= 4 weeks prior to randomization or anticipation of need for major surgical procedure during the course of the study
* Minor surgery <= 2 weeks prior to randomization. Insertion of a vascular access device is not considered major or minor surgery in this regard. Patients must have recovered from all surgery-related toxicities
* Peripheral neuropathy with functional impairment >= Common Terminology Criteria (CTC) grade 2 neuropathy, regardless of causality
* Pleural effusion or ascites that causes respiratory compromise (>= CTC grade 2 dyspnea)
* Concurrent severe and/or uncontrolled cardiac, vascular or infectious conditions (as described in the protocol) which could compromise participation in the study
* Patients at risk of QT prolongation such as patients with congenital long QT syndrome or with long corrected QT (QTc) at baseline (i.e. QTc greater than 450 msec in males, and greater than 470 msec in females) will be excluded
* Lung carcinoma of squamous cell histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable).
|
NCT_ID
NCT00572078
|
Study_NameSorafenib and Bevacizumab in Combination With Paclitaxel in Patients With Solid Tumors
| 17,983 |
Study Objectives
T-1101 is a novel anti-cancer agent being developed by Taivex Therapeutics Corporation, and is being studied in a phase I dose escalation trial, protocol TAI-001. That trial's primary aim is to study the safety and tolerability of T-1101 (Tosylate) in subjects with advanced refractory solid tumors, and provides for a maximum of 2 cycles of treatment. At the end of 2 cycles of treatment, it is likely that some patients will be continuing to receive clinical benefit from T-1101 (Tosylate). The intention of this program is to enable these patients to continue to receive T-1101 (Tosylate) at the discretion of the principal investigators and Taivex Therapeutics Corporation.
Conditions: Advanced Refractory Solid Tumors
Intervention / Treatment:
DRUG: T-1101 (Tosylate)
Location: Taiwan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with advanced malignancy who are receiving T-1101 (Tosylate) in a previous Taivex Therapeutics Corp. sponsored study that has reached its endpoint, and who are, in the opinion of the investigator and/or sponsor, expected to continue to have an overall positive benefit/risk from continuing treatment.
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing.
* Women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of T-1101 (Tosylate) in this long term extension trial.
* Patients who have completed the End of Study assessments in their originating study. Every effort should be made to conduct the End of Study visit such that the patient does not have any interruption in T-1101 (Tosylate) dosing.
* Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
* Any medical condition that, in the opinion of the investigator and/or sponsor, could jeopardize the safety of the patient.
* Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
* Progressive or untreated metastatic brain or meningeal tumors.
* Pregnancy or breastfeeding. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. Female patients must be surgically sterile or be postmenopausal, or must agree to the use of highly effective contraception during the period of therapy. Highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, or a vasectomized partner.
* Substance abuse, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
|
NCT_ID
NCT03349073
|
Study_NameAn Extension Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors
| 1,026 |
Study Objectives
This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.
Conditions: Nasopharyngeal Carcinoma
Intervention / Treatment:
DRUG: Nedaplatin, DRUG: Cisplatin
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
* Original clinical staged as T1 <= age <= 4N1 <= age <= 3 or T3 <= age <= 4N0（according to the 7th AJCC edition）
* No evidence of distant metastasis (M0)
* Male and no pregnant female
* Age between 18 <= age <= 65
* WBC >= 4,000/mm3 and PLT >= 100,000/mm3
* With normal liver function test (ALT、AST <= 2.5×ULN)
* With normal renal function test (Creatinine <= 1.5×ULN)
* Satisfactory performance status: Karnofsky scale (KPS)> 70
* Without radiotherapy or chemotherapy
* Patients must give signed informed consent
Exclusion Criteria:
* Patients have evidence of relapse or distant metastasis
* The presence of uncontrolled life-threatening illness
* Receiving other ways of anti-cancer therapy
* Receiving radiotherapy or chemotherapy
* Pregnancy or lactation
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NCT_ID
NCT01540136
|
Study_NameConcurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma
| 9,995 |
Study Objectives
Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. This kind of drug has little effect on respiratory function, is easy to wake up and has analgesic effect. It is a commonly used perioperative adjuvant drug. However, for neurosurgical patients with brain tumors, the role of DEX in POD is not clear. The purpose of this study was to investigate the effect of DEX on POD in neurosurgical brain tumor surgery.
Conditions: Dexmedetomidine, Postoperative Delirium
Intervention / Treatment:
DRUG: Dexmedetomidine, DRUG: 0.9% saline
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Patients undergoing selective frontotemporal tumor resection.
* Age >=18 years.
* Obtain written informed consent.
Exclusion Criteria:
* Refusal to provide written informed consent.
* Preoperative severe cognitive impairment (mini-mental state examination, MMSE <= 20).
* Allergic to the study drug.
* History of psychotropic drugs within past 30 days.
* Pregnant or lactating women.
* History of traumatic brain injury or neurosurgery.
* Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
* Severe hepatic or renal dysfunction.
|
NCT_ID
NCT04674241
|
Study_NameDexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections
| 6,593 |
Study Objectives
Studying samples of blood and tissue in the laboratory from patients with a high risk of developing ovarian cancer may help doctors identify and learn more about biomarkers related to cancer. We hypothesized that (i) preclinical biologic evidence exists for the role of androgens in ovarian cancer development and (ii) flutamide treatment of women at high risk for ovarian cancer may identify meaningful tissue biomarkers of androgen action and of ovarian cancer initiation. This phase II trial studied the effect of flutamide on biomarkers in blood and tissue samples from patients at high risk of ovarian cancer.
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: flutamide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: PREVENTION
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria for all patients:
* >= 18 years
* Able to comply with study and follow-up requirements
Inclusion Criteria for high risk patients:
* elected to undergo prophylactic salpingo-oophorectomy
* fertile patients must use effective non-hormonal contraception
* agreed to use a nonhormonal means of contraception before surgery
* serum bilirubin <= 1.0 x Upper Limit Normal (ULN), alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 2.5 x ULN
* serum creatinine <= 1.5 x ULN
* granulocyte count >= 1500/μL
* platelet count >= 75,000/μL
* hemoglobin >= 9 g/dL
* adequate complete blood count
* At high risk for developing ovarian cancer, as defined by any of the following:
* Breast Cancer carried a BRCA1 or BRCA2 deleterious mutation, a Lynch syndrome mutation, and/or defined by a family history of: 1 first-degree relative with epithelial ovarian cancer, >=1 first-degree female relative with breast cancer when <=40 years, >=1 first-degree female relative with breast cancer when <=50 years, male relative with breast cancer, and/or family history of breast cancer or ovarian cancer.
Inclusion Criteria for low risk patients:
* planning to undergo oophorectomy for a medical indication
* did not fulfill criteria for high risk of developing ovarian cancer
Exclusion criteria:
* liver disease, current alcohol abuse, or cirrhosis
* pregnancy or lactation
* current use of hormone therapy
* active treatment for cancer
* recent, current, or planned participation in another experimental drug study
* breast cancer within the past 5 years
* significant traumatic injury within the past 6 months
* major surgery within the past 6 months
* any disease, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates the continued use of an investigational drug or that may render the patient at high risk from treatment complication
|
NCT_ID
NCT00699907
|
Study_NameEffect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer
| 15,968 |
Study Objectives
The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated dose of LCL161.
Conditions: Advanced Solid Tumors
Intervention / Treatment:
DRUG: LCL161
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Solid tumor
* ECOG performance status 0 <= age <= 2
* Life expectancy greater than or equal to 12 weeks
* Must meet certain blood laboratory values
* Must meet criteria for time since the last dose of prior therapy
* Must provide written informed consent to participate in this study
Exclusion Criteria:
* Active and/or symptomatic brain tumors or brain metastases.
* Patients with unresolved nausea, vomiting, or diarrhea
* Any ongoing severe and/or uncontrolled medical condition that could compromise participation in the study including heart, lung or inflammatory disease
* Any disease that may significantly alter the absorption of the study drug (for example, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or removal of small bowel)
* Patients who are currently receiving treatment with steroids at a certain dose or other immunosuppressive treatment that cannot be stopped prior to starting study drug
* Patients who are currently receiving treatment with certain medications
* Patients who have received radiation therapy or have undergone major surgery within the last 4 weeks
* Women of child-bearing potential who are pregnant or breast feeding.
* Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
* Patients unwilling or unable to follow the protocol
Other protocol-defined inclusion/exclusion criteria may apply
|
NCT_ID
NCT01098838
|
Study_NameSafety and Efficacy of LCL161 in Patients With Solid Tumors
| 14,307 |
Study Objectives
The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.
Conditions: Lymphoma
Intervention / Treatment:
DRUG: Ibrutinib, DRUG: Placebo, DRUG: Rituximab, DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Prednisone (or equivalent)
Location: Poland, United Kingdom, Australia, Denmark, Norway, France, Korea, Republic of, Netherlands, Canada, Turkey, China, Finland, Ukraine, Germany, Sweden, Spain, Czechia, Taiwan, Argentina, Israel, United States, Brazil, Japan, Belgium, Russian Federation, Mexico, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion Criteria:
* No prior treatment for diffuse B-cell lymphoma (DLBCL)
* Histologically-confirmed non-germinal center B-cell subtype DLBCL
* Stage II (not candidates for local x-ray therapy), III, or IV disease by the Ann Arbor Classification
* At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
* Revised International Prognostic Index score of >=1
* Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2
* Hematology and biochemical laboratory values within protocol-defined parameters prior to random assignment and at baseline
* Left ventricular ejection fraction within institutional normal limits, as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan
* Agrees to protocol-defined use of effective contraception (for women, these restrictions apply for 12 months after the last dose of rituximab or 1 month after the last dose of study drug, whichever is later; for men, these restrictions apply for 12 months after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later)
* Men must agree to not donate sperm during and after the study for 12 months after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later
* Women of childbearing potential must have a negative serum or urine pregnancy test at screening
Exclusion Criteria:
* Major surgery within 4 weeks of random assignment
* Known central nervous system or primary mediastinal lymphoma
* Prior history of indolent lymphoma
* Diagnosed or treated for malignancy other than DLBCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease
* History of stroke or intracranial hemorrhage within 6 months prior to random assignment
* Requires anticoagulation with warfarin or equivalent vitamin K antagonists
* Requires treatment with strong CYP3A inhibitors
* Prior anthracycline use >=150 mg/m2
* Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
* Known history of human immunodeficiency virus or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antibiotics
* Women who are pregnant or breastfeeding
* Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
|
NCT_ID
NCT01855750
|
Study_NameA Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
| 13,804 |
Study Objectives
The goal of this clinical research study is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma.
Primary Objective:
* The primary objective of the Phase I is to determine the toxicity, safety and the maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin, Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma.
Secondary Objectives:
* To assess responses to the combination.
* To evaluate the duration of response and the overall survival.
* To determine the effectiveness in delaying the appearance of Central Nervous System disease.
Conditions: Melanoma
Intervention / Treatment:
DRUG: Temozolomide, DRUG: Abraxane, DRUG: Cisplatin, BIOLOGICAL: Interleukin-2, BIOLOGICAL: Interferon alpha 2b
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible.
* They should have recurrent melanoma with measurable or evaluable sites of disease, 1.0 cm or larger, in order to assess the response to treatment by RECIST.
* They should not have been exposed to any previous chemotherapy or isolation perfusion for malignant melanoma and have had no previous exposure to interleukin-2. Prior adjuvant interferon is permitted.Prior radiation therapy for metastatic melanoma is permitted provided the patient has un-irradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
* Patients between 18 years and 65 years with an expected survival greater than 8 weeks and a Karnofsky performance status of 50% or better or an ECOG performance status of 0, 1 or 2 will be eligible.
* They should have normal blood counts with a WBC count of more than or equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3 and a platelet count of more than 100,000/mm^3 and have no impairment of renal function (serum creatinine less than 1.1 mg/dl for females and less than 1.4 mg/dl for males), hepatic function (serum bilirubin level of less than 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.
* They should have no significant intercurrent illness such as an active infection, uncontrolled psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active GI bleeding.
Exclusion Criteria:
* Patients with bone metastases only.
* Patients with brain metastases unless their disease has been resected and they are off corticosteroids. Patients with spinal cord compression and leptomeningeal disease. No major surgery or radiation therapy within 21 days before starting treatment.
* Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (EF less than 55%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients with an EKG disclosing an absolute QT interval greater than 460 msec in the presence of serum potassium greater than or equal 4.0 mEq/L and magnesium greater than/=1.8 mg/dL.
* Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of FEV1 to less than 75% of predicted normal values.
* Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
* Patients who are unable to stay in Houston to receive therapy (first cycle) and/or unable to return for follow-up visits as required by this study.
* Patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 5 years and uncertainty about the histological nature of the metastatic lesions.
* Patients with history of DVT or PE are excluded.
|
NCT_ID
NCT00970996
|
Study_NameCisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma
| 6,958 |
Study Objectives
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and mifepristone when given together with carboplatin in treating patients with breast cancer that is metastatic or cannot be removed by surgery or recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Steroid hormones can cause the growth of cancer cells. Hormone therapy using mifepristone may fight breast and ovarian cancer by lowering the amount of steroid hormone the body makes. Giving carboplatin and gemcitabine hydrochloride together with mifepristone may be an effective treatment for breast, ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Conditions: Male Breast Cancer, Recurrent Breast Cancer, Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
Intervention / Treatment:
DRUG: mifepristone, DRUG: carboplatin, DRUG: gemcitabine hydrochloride, OTHER: laboratory biomarker analysis, OTHER: pharmacological study
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients are eligible if they have the following: metastatic or unresectable breast cancer, recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Ovarian cancer patients with both platinum-sensitive and platinum-resistant disease are eligible. Ovarian cancer patients with platinum refractory disease (failure to achieve a complete response to first line platinum therapy) are ineligible.
* Men with metastatic or unresectable breast cancer are eligible
* Patients must have measurable or evaluable disease (subjects with elevation of tumor marker with no evidence of disease on imaging or exam are not eligible)
* Patients with breast cancer may have received neoadjuvant or adjuvant chemotherapy and up to two prior chemotherapy regimens for metastatic or locally recurrent disease; subjects with ovarian cancer may have had two regimens for advanced or persistent disease
* Patients with both ER positive and ER negative breast cancer are eligible for this study. Patients with HER2 positive disease will be excluded from participation in this study.
* Metastatic breast cancer patients who are hormone receptor positive at baseline must be hormone refractory or have indications for emergent treatment with chemotherapy (e.g., visceral crisis).
* Patients with known brain metastases will be eligible as long as they have completed radiation to the brain and have been off of corticosteroid therapy for at least 2 weeks prior to study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 2 (Karnofsky > 60%)
* Absolute neutrophil count >= 1,500/mL
* Platelets >= 100,000/mL
* Total bilirubin =< institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) 5 =< X institutional ULN
* Creatinine =< institutional ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
* Morning cortisol >= institutional normal
* If a woman is of childbearing potential, a negative serum or urine pregnancy test is required; women of child-bearing potential and men who are sexually active must agree to use birth control such as barrier method of birth control, abstinence, or else be surgically sterile (tubal ligation, hysterectomy or partner with confirmed vasectomy) prior to study entry and for the duration of study participation; hormonal contraception is not permitted on trial; alternatively the patient must be post-menopausal defined as greater than 12 months without a menstrual cycle; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; nursing patients must discontinue breast feeding prior to the initiation of therapy
* Ability to understand and willingness to sign an informed consent document
* Bisphosphonate (e.g. zoledronic acid) and receptor activator of nuclear transcription factor kappa-B (NF-kappaB) ligand (RANKL) inhibitor (e.g. denosumab) use for bone metastasis is permitted
Exclusion Criteria:
* Patients who have not recovered from toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment. All patients must have a two week washout period from prior chemotherapy.
* Patients must be at least two weeks from prior radiation therapy (RT)
* Patients must have a one week washout period from prior hormonal therapy (e.g. testosterone, estrogen, progestin, gonadotropin-releasing hormone antagonist)
* Patients may not be receiving any other investigational agents
* Mifepristone inhibits cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) and induces CYP3A4; addition of mifepristone to a pre-existing drug regimen may cause a mild and temporary increase in plasma drug concentration of drugs with significant CYP3A4 metabolism; medications that are strong inducers of CYP3A4 such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's Wort may decrease plasma mifepristone levels; strong CYP3A4 inhibitor medications are expected to cause the largest increases in plasma mifepristone concentrations; mifepristone may increase the plasma drug concentration of concomitant medications with metabolism mediated by cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9)/cytochrome P450, family 2, subfamily C, polypeptide 8 (2C8)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study; breastfeeding should be discontinued if patient wishes to participate in study
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
* History of long-term use of corticosteroids or concurrent short-term use of corticosteroids is not allowed; short-term corticosteroid use must be discontinued at least 2 weeks prior to study treatment
* Prior mifepristone use for anticancer therapy is not allowed
* Patients with advanced breast cancer who have received platinum therapy (e.g. carboplatin or cisplatin) and/or gemcitabine therapy for metastatic disease are excluded (platinum-based therapy and/or gemcitabine in the adjuvant or neoadjuvant setting is allowed)
* Ovarian cancer patients who have received prior gemcitabine therapy are ineligible; (prior carboplatin therapy is allowed)
* Patients with known grade 2 or greater allergic reactions attributed to compounds of similar chemical or biologic composition to mifepristone, carboplatin, or gemcitabine are ineligible for study enrollment
|
NCT_ID
NCT02046421
|
Study_NameCarboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
| 16,698 |
Study Objectives
Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. This phase I/II trial is studying the side effects and best dose of fluorouracil and the chemosensitizer suramin and to see how well they work in treating patients with metastatic renal cell (kidney) cancer.
Conditions: Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer
Intervention / Treatment:
DRUG: Fluorouracil, OTHER: Pharmacological Study, DRUG: Suramin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed renal cell cancer
* Metastatic disease
* Measurable or evaluable disease
* Measurable disease required for phase II
* No untreated CNS metastasis or CNS metastases progressing <= 4 weeks after prior radiotherapy
* Performance status - ECOG 0 <= age <= 1
* At least 12 weeks
* Absolute neutrophil count >= 1,500/mm^3
* Platelet count >= 100,000/mm^3
* Hemoglobin >= 9.0 g/dL
* AST <= 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase <= 5 times ULN
* Bilirubin <= 1.5 mg/dL
* Creatinine <= 1.8 mg/dL
* Calcium <= ULN
* No untreated hypercalcemia
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must be surgically sterile or use effective contraception
* No uncontrolled diabetes mellitus
* No known severe hypersensitivity to suramin
* No other concurrent uncontrolled illness
* No active or ongoing infection
* No active autoimmune disease
* No neuropathy >= grade 2
* No psychiatric illness or social situation that would preclude study compliance
* No other malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or localized prostate cancer
* No concurrent filgrastim (G-CSF)
* No more than 2 prior chemotherapy regimens for renal cell cancer (phase II only)
* No concurrent corticosteroid dose more than physiologic replacement levels
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
* Recovered from prior oncologic or other major surgery
* At least 4 weeks since prior major surgery
* No concurrent surgery
* Recovered from all prior anticancer therapy other than alopecia (chronic toxicity < grade 2)
* At least 4 weeks since prior systemic therapy
* More than 30 days since prior investigational drugs
* Concurrent bisphosphonates allowed
|
NCT_ID
NCT00083109
|
Study_NameFluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
| 18,115 |
Study Objectives
The purpose of this study is to determine a safe, effective, and tolerable dose of PRX302 for the treatment of low to intermediate risk prostate cancer.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: PRX302
Location: United Kingdom, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Life expectancy >= 10 years.
* Serum prostate-specific antigen (PSA) <= 15ng/mL.
* A histologically proven, clinically significant lesion visible on mpMRI (magnetic resonance imaging) that is accessible to PRX302 transperineal injection.
* Radiological stage T1-T2 N0 Mx/M0 disease.
* Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.
Exclusion Criteria:
* Previous radiation therapy to the pelvis.
* Androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.
* Use of 5-alpha reductase inhibitor within the 3 months prior to dosing.
* Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
* Inability to tolerate transrectal ultrasound (TRUS).
* Known allergy to latex or gadolinium (Gd).
* Prior rectal surgery preventing insertion of the TRUS probe.
* Any previous ablative procedures performed on the prostate, e.g., electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, photochemical, thermal or microwave therapy to treat cancer of the prostate.
* Unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc., likely to contribute significant artifact to images).
|
NCT_ID
NCT03081481
|
Study_NameIntraprostatic PRX302 Injection to Treat Localised Prostate Cancer
| 14,118 |
Study Objectives
Osteosarcoma is the most common type of bone cancer in children, adolescents and young adults. Treatment with surgery and a combination of three conventional chemotherapy drugs can cure nearly two-thirds patients with osteosarcoma, but the treatment can also cause irreversible damage to the kidneys and cause permanent hearing loss. The purpose of this study is to evaluate new approaches to prevent these side effects without interfering with the beneficial effects of the chemotherapy drugs on the cancer by using our knowledge of how the drugs damage the kidney and cochlear hair cells in the ear to selectively block these side effects. Preventing these side effects without interfering with the anti-cancer effect of the drugs will improve the outcome in survivors and may also improve the effectiveness of the chemotherapy regimen by preventing treatment delays and dose reductions that are often caused by the side effects. Patients will be carefully monitored to ensure that the new interventions do not adversely affect response to the treatment and do not increase the other side effects of the chemotherapy. Specifically, we will monitor the nutritional status of the patients closely and ask patients to complete a survey describing the side effects after each treatment cycle. We will also collect a small sample of cancer tissue at the time of biopsy and surgery from each patient on this study for testing to determine new classes of anti-cancer drugs currently under development may have a role in treating osteosarcoma. If effective, these new approaches to prevent kidney damage and hearing loss will be applicable in other types of cancers treated with the same chemotherapy drugs.
Conditions: Osteosarcoma, Nephrotoxicity, Ototoxicity
Intervention / Treatment:
DRUG: Pantoprazole, DRUG: High-dose methotrexate infusion duration
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
|
Inclusion Criteria:
* <30 years
* histological diagnosis of high-grade osteosarcoma
* Extremity or central axis (including craniofacial) primary tumor; localized or metastatic
* No prior chemotherapy or radiation therapy for osteosarcoma. Subjects who develop osteosarcoma as a second cancer are eligible if they have not previously received cisplatin, doxorubicin or other anthracyclines, or MTX
* Serum creatinine at or below the upper limit of normal (ULN) for age and gender
* Shortening fraction on echocardiogram >28%
* Hearing level threshold <=25 dB at all frequencies in both ears to be evaluable for evaluation of pantoprazole's effect on cisplatin ototoxicity. Patients with hearing loss can be enrolled but will not be evaluable for ototoxicity objective.
* Absolute neutrophil count >1,000/microliter(mcL) and platelet count >100,000/mcL
Exclusion Criteria:
* Receiving H2 antagonists (cimetidine, ranitidine, famotidine, nizatidine) or proton pump inhibitors (lansoprazole, omeprazole, pantoprazole, esomeprazole, rabeprazole, dexlansoprazole) AND unable to hold the drug for 24 h prior to and 24 h after each cisplatin course on cycles 1 <= age <= 4.
* Pregnant or breastfeeding
* Unable to cooperate with research procedures
|
NCT_ID
NCT01848457
|
Study_NamePreventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy
| 123 |
Study Objectives
The main purpose of this study is to see whether the combination of trametinib and sorafenib can help people with hepatocellular cancer. Researchers also want to find out if the combination of trametinib and sorafenib is safe and tolerable.
Conditions: Hepatocellular Cancer, Liver Cancer
Intervention / Treatment:
DRUG: Trametinib, DRUG: Sorafenib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Must have radiographic or histological diagnosis of hepatocellular cancer (HCC), with advanced stage disease that is not amenable to curative surgical resection. Potential participants without histologic diagnosis must meet the radiographic criteria for HCC.
* Child Pugh score must be 5 or 6 (Child Pugh Class A)
* Must have measurable disease by RECIST criteria 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status <=1
* Must have normal organ and marrow function
* Female participants of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for four months following the last dose.
* Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
* Participants in the dose expansion part must have tumor that is amenable for biopsy.
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Have received radiation therapy, major surgery, other locoregional therapy, within 4 weeks prior to the first dose of study drug
* All prior treatment-related toxicities must be <= Grade 1.
* Have received sorafenib or other systemic therapies for treatment of HCC in the past
* Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception), psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures
* History or evidence of cardiovascular risk
* Known history of human immunodeficiency virus (HIV) positivity
* History of retinal vein occlusion (RVO)
* Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
* History of interstitial lung disease or pneumonitis
* Are pregnant or lactating
* Any underlying condition that would significantly interfere with the absorption of an oral medication
* History of another active malignancy in last 3 years. Exception: Potential participants who have been disease-free for 3 years, or have a history of completely resected nonmelanoma skin cancer and/or potential participants with indolent second malignancies are eligible.
* Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study
* Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug, or excipients or to dimethyl sulfoxide
* Concurrent therapy with approved or investigational anticancer therapy
* Concomitant use of strong Cytochrome P450 3A4 (CYP3A4) inducers
|
NCT_ID
NCT02292173
|
Study_NameTrametinib in Combination With Sorafenib in Patients With Advanced Hepatocellular Cancer
| 1,247 |
Study Objectives
This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.
Conditions: HSIL of Cervix, HSIL, High Grade Squamous Intraepithelial Lesions, High-Grade Cervical Intraepithelial Neoplasia, Human Papilloma Virus, HIV Negative, Cervical Cancer, CIN - Cervical Intraepithelial Neoplasia, Cervical Neoplasm, Cervical Dysplasia
Intervention / Treatment:
DRUG: Topical ABI-1968
Location: South Africa
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* Women, 25 <= age <= 50 old.
* Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen.
* Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible.
* The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.
Exclusion Criteria:
* Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
* HIV positive (tested at screening visit or within 3 months of screening visit).
* Resolution of visible CIN lesion prior to enrollment.
* ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.
* History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
|
NCT_ID
NCT03697226
|
Study_NameStudy of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.
| 820 |
Study Objectives
This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).
Conditions: Non-Hodgkin's Lymphoma
Intervention / Treatment:
DRUG: Obinutuzumab, DRUG: Bendamustine
Location: Germany, Sweden, United States, Czechia, Spain, United Kingdom, Italy, Netherlands, Austria, Belgium, Canada, Russian Federation, France, Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* History of histologically documented, B-lymphocyte antigen cluster of differentiation 20 plus (CD20+), iNHL
* Refractory to any previous regimen containing rituximab (defined by participants who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen)
* Previously treated with a maximum of four unique chemotherapy containing treatment regimens
* All participants must have at least one bi-dimensionally measurable lesion (greater than [>]1.5 centimeters (cm) in its largest dimension by computed tomography [CT] scan)
Exclusion Criteria:
* Prior use of any monoclonal antibody (other than anti-CD20) within 3 months prior to the start of Cycle 1, prior treatment with obinutuzumab was not allowed
* Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
* Prior treatment with bendamustine (within 2 years of the start of Cycle 1)
* Prior allogeneic stem cell transplant
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* History of sensitivity to mannitol
* Central nervous system lymphoma or prior diffuse large B-cell lymphoma (DLBCL), histological evidence of transformation to high grade or diffuse large B-cell lymphoma
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks
* Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
* Vaccination with a live vaccine a minimum of 28 days prior to randomization
* Recent major surgery (within 4 weeks), other than for diagnosis
* Presence of positive test results for Hepatitis B surface antigen (HBsAg); antibody to hepatitis B core antigen [anti-HBc]) with detectable viral load (positive hepatitis B virus [HBV] deoxyribo-nucleic acid [DNA]) or Hepatitis C
* Participants with chronic hepatitis B or seropositive occult (HBV) infection
* Participants with seronegative occult HBV infection or past HBV infection (defined as anti-HBc positive and HBV DNA negative) could be eligible if they were willing to be followed according to the protocol for HBV DNA testing
* Participants positive for Hepatitis C virus (HCV) antibody were eligible only if polymerase chain reaction(PCR) was negative for HCV Ribonucleic acid (RNA)
* Known history of human immunodeficiency virus (HIV) seropositive status
* Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic countries
* Women who are pregnant or lactating
* Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
* Ongoing corticosteroid use >30 milligrams per day (mg/day) prednisone or equivalent
|
NCT_ID
NCT01059630
|
Study_NameA Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)
| 580 |
Study Objectives
This study has two parts, dose escalation and dose expansion. For dose escalation, the primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with uveal melanoma. For dose expansion, the primary objective is to characterize the safety and tolerability of the MTD of AEB071 in patients with uveal melanoma.
Conditions: Uveal Melanoma
Intervention / Treatment:
DRUG: AEB071
Location: France, United Kingdom, Netherlands, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Uveal melanoma with biopsy proven metastatic disease
* Males and females >= 18 years
* Consent to biopsy of tumor
* Measurable disease according to RECIST version 1.1
* WHO performance status of <= 1
Exclusion Criteria:
* Patients with abnormal laboratory values as defined by the protocol
* Patients who are receiving treatment with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued prior to study entry
* Patients with impaired cardiac function or clinically significant cardiac diseases as defined by the protocol
* Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma
* Patients with impairment of gastrointestinal function or disease
* Patients with severe systemic infections
* Patients who are known to be HIV positive and/or have active hepatitis B or C infection
* Time since last therapy for treatment of underlying malignancy:
* Cytotoxic chemotherapy: <= duration of the most recent cycle of the previous regimen (a minimum of 2 weeks for all)
* Nitrosurea: <= 6 weeks
* Biologic therapy: <= 4 weeks
* <= 5 x PK half-life of a small molecule therapeutic not otherwise defined above
* Patients having undergone major surgery less than 4 weeks prior to enrollment or have not fully recovered from prior surgery
* Women of child-bearing potential unless they are using highly effective methods of contraception during the dosing and for at least 36 hours after last dose. Highly effective contraception as defined in the protocol.
* Patients with primary central nervous system tumors or brain metastases.
* Pregnant or nursing (lactating) women.
Other protocol-defined inclusion/exclusion criteria may apply
|
NCT_ID
NCT01430416
|
Study_NameSafety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients
| 4,828 |
Study Objectives
This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab. This study will also look at other effects of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab, including its effect on this type of cancer.
Interferon-gamma is a biologically manufactured protein that is similar to a protein the body makes naturally. In the body, interferon gamma is produced by immune cells and helps to prevent serious infections.
Conditions: Breast Cancer, Breast Cancer, Male, Breast Cancer Female, HER2-positive Breast Cancer
Intervention / Treatment:
BIOLOGICAL: Interferon-gamma (IFN-γ), DRUG: Paclitaxel, DRUG: Trastuzumab, OTHER: Pertuzumab, PROCEDURE: Post Therapy Surgery
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* Participants must have a histologically confirmed HER2 positive breast cancer (by ImmunoHistoChemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) ratio >= 2.0). Phase 1: unresectable locally advanced or metastatic breast cancer. Phase 2: clinical stage 1 <= age <= 3 early stage breast cancer with primary tumor is at least 1cm measured by clinical exam or by radiologic breast imaging tests.
* Prior Therapy - Phase 1: Must be candidates to receive paclitaxel chemotherapy in combination with trastuzumab and pertuzumab. Phase 2: No prior chemotherapy, radiation, or definitive therapeutic surgery (e.g., mastectomy, lumpectomy or axillary dissection) for this malignancy. Patients who have had a prior sentinel lymph node biopsy for this malignancy are eligible. Patients who received equal to or less than 1 cycle of therapy (up to 4 weeks) will be allowed to enroll in this trial.
* Patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for the prevention or treatment of breast cancer or for other indications (e.g., osteoporosis, prior ductal carcinoma in situ (DCIS)), or who receive aromatase inhibitors for prevention or treatment of breast cancer, are eligible. Patients who are hormone-receptor positive and who have received other hormonal agents for the treatment of breast cancer (e.g., Fulvestrant®) are also eligible. Tamoxifen therapy or other hormonal agents should be discontinued at least 1 week before the patient is started on study therapy.
* Age >= 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Must have normal organ and marrow function within 2 weeks of registration (except where specified otherwise).
* Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
* Receiving any other investigational agents during protocol therapy, or up to 14 days or 5 half-lives (whichever is longer) prior to beginning protocol therapy. There should be a least a 1-week interval between last dose of endocrine therapy and protocol therapy.
* Have had chemotherapy or radiation therapy within 2 weeks prior to beginning protocol therapy.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Current use of corticosteroid therapy > 5 mg/day of prednisone or equivalent doses of other corticosteroids (topical, intranasal, and inhaled corticosteroids in standard doses and physiologic replacement for participants with adrenal insufficiency are allowed).
* Known active or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Asymptomatic, treated, and/or stable brain metastases, as measured by subsequent radiologic evaluations at least two months apart, are permitted.
* Pregnant or breast feeding.
* Known HIV-positive.
* Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared.
* Major surgery within 4 weeks of initiation of study drug.
* Second invasive malignancy requiring active treatment.
|
NCT_ID
NCT03112590
|
Study_NamePhase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer
| 14,214 |
Study Objectives
This prospective, post marketing, observational, Noninterventional Study (NIS) is designed to compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF) inhibitor.
Conditions: Rheumatoid Arthritis
Location: Germany
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Diagnosis of Rheumatoid Arthritis (RA)
* Moderate to severe disease activity of RA
* The patient receives Tumor Necrosis Factor (TNF) inhibitor in combination with at least 1 synthetic Disease Modifying Antirheumatic Drug (DMARD)
* The decision to prescribe a TNF inhibitor in combination with DMARD is made by the treating physician, prior to and independently from the decision to include the patient in this Non-Interventional Study (NIS)
* Male or female patients >= 18 years, considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires)
* The patient personally signed and dated Patient Data Consent Form (PDCF) prior to Visit 2
* Treatment is according to the Summary of Product Characteristics (SmPC)
Exclusion Criteria:
* Known contraindications to Tumor Necrosis Factor (TNF) inhibitors
* Prior use of any TNF inhibitors (including Adalimumab, Etanercept, Infliximab, Certolizumab, or Golimumab), or other biologic DMARDs (including Abatacept, Rituximab, Tocilizumab, or Anakinra)
* Participation in an investigational study
|
NCT_ID
NCT01764321
|
Study_NameNoninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors
| 16,191 |
Study Objectives
There is clinical benefit of docetaxel administered to patients who have progressed to 3 or more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic responses are obtained that it never received taxanes.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
DRUG: Docetaxel
Location: Mexico
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria: Women > 21 years diagnosed with breast cancer in clinical stage IV, who had received 3 or more lines of cytotoxic chemotherapy, which may have included paclitaxel or docetaxel, which have measurable or evaluable tumor activity in any distant organ and who are fully conscious and well oriented to permit informed consent.
Exclusion Criteria:
Male patients with metastatic breast cancer. Patients with grade 3 neuropathy by prior exposure to taxanes. Patients under 21 and > 85 years. Metastasis of one site in the central nervous system.
|
NCT_ID
NCT02041351
|
Study_NameBiweekly Docetaxel in Patients With Metastatic Breast Cancer.
| 21,859 |
Study Objectives
This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with advanced soft tissue sarcoma. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.
Conditions: Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
Intervention / Treatment:
DRUG: vorinostat, DRUG: bortezomib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Histologically or cytologically confirmed advanced, unresectable, or metastatic soft tissue sarcoma (STS)
* Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension as >= 2 cm by conventional techniques OR >= 1 cm by spiral computed tomography (CT) scan
* No small round cell tumors, including the following:
* Primitive neuroectodermal tumor
* Rhabdomyosarcoma
* Ewing sarcoma
* Osteosarcoma
* No known active and/or untreated brain metastases and/or brain metastases requiring ongoing therapy (e.g., corticosteroids)
* Treated, inactive brain metastases not requiring ongoing therapy allowed provided the brain metastases have been stable for >= 1 month as assessed by intracranial imaging AND there is no indication of increased vascularity of the treated metastases within 14 days before study entry as assessed by magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 <= age <= 1 OR Karnofsky PS 70 <= age <= 100%
* Life expectancy >= 12 weeks
* Absolute neutrophil count (ANC) >= 1,500/mm^3
* Platelet count >= 100,000/mm^3
* Total bilirubin normal
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance >= 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to take oral medication
* No peripheral neuropathy >= grade 2
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia or myocardial infarction within the past 6 months
* Psychiatric illness and/or social situation that would limit compliance with study requirements
* No history of Torsades de Pointes
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to vorinostat or bortezomib
* No more than 1 prior systemic treatment for advanced STS, including investigational agents
* Adjuvant therapy is not considered a systemic regimen
* More than 2 weeks since prior valproic acid
* More than 4 weeks since prior and no concurrent chemotherapy (> 6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
* Radiotherapy to bone metastasis within the past 2 weeks allowed provided there is active non-bone disease outside the radiation port
* No prior radiotherapy to >= 33% of the bone marrow
* No prior vorinostat or bortezomib
* No concurrent category I medications that are generally accepted to have a risk of causing Torsades de Pointes, including any of the following:
* Quinidine, procainamide, disopyramide
* Amiodarone, sotalol, ibutilide, dofetilide
* Erythromycin, clarithromycin
* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
* No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
* No other concurrent investigational agents for the primary malignancy
* No other concurrent anticancer therapy
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NCT_ID
NCT00937495
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Study_NameVorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma
| 13,855 |
Study Objectives
Laser treatment (LT) is the first-line treatment for Vascular Pathology. However even when LT is based on the selective photothermolysis it causes the first-degree burns. While being typically benign by affecting only the epidermis, or outer layer of skin, the burn site is remaining red, dry, and very painful. As Haemoblock contains nanoparticles of silver and is known for both bactericidal and bacteriostatic effects, it likely decreases the potential for infection postoperatively. Furthermore, after fibrin replaces the superficial structure "Hemoblock-albumin", the polyacrylate matrix is plasmolyzed which initiates the cascade of signals required for the tissue regeneration processes. Objective of the study was to examine the effect of the Regenerative Solution "Hemoblock" in lowering postoperative complications in children diagnosed with Vascular Pathology undergoing a laser surgery if delivered with transdermal patches.
Conditions: Vascular Diseases, Vascular Malformation, Capillary Malformation-Arteriovenous Malformation, Port-Wine Stain, Sturge-Weber Syndrome, Vascular Tumor
Intervention / Treatment:
DRUG: Haemoblock, OTHER: Placebo
Location: Russian Federation
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
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Inclusion Criteria:
* clinically diagnosed Vascular Pathology
Exclusion Criteria:
* age
* severe allergic reaction
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NCT_ID
NCT04999618
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Study_NameA New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology
| 8,196 |
Study Objectives
The purpose of this study is to find out how well patients with cancer of the rectum do if they get all of their other treatment - chemotherapy by itself followed by chemotherapy and radiation together - before surgery. Patients have recently been diagnosed with rectal cancer, and the doctors have recommended neo-adjuvant chemo treatment to try to shrink the cancer before removing it.
Conditions: Colon Cancer, Rectal Cancer
Intervention / Treatment:
DRUG: FOLFOX6, RADIATION: RT with concurrent chemotherapy, PROCEDURE: Surgery
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria
* Patients must have histologically proven adenocarcinoma of the rectum with no evidence of distant metastases.
* The tumor must be clinically Stage II (T3 <= age <= 4 N0 with N0 being defined as all imaged lymph nodes are < 1.0cm) or III (T1 <= age <= 4 N1 <= age <= 2 with the definition of a clinically positive node being any node > 1.0cm). Stage of the tumor may be determined by CT scan, endorectal ultrasound or MRI.
* Patients must have no evidence of distant metastases including liver metastases, peritoneal seeding, or inguinal lymphadenopathy.
* Patients must not have received prior chemotherapy or pelvic radiation for rectal cancer, or prior pelvic radiation for any other malignancy that would prevent the patient from receiving the required radiation treatments for this study.
* Patients must have a life expectancy of 5 years, excluding their diagnosis of cancer (as determined by the investigator).
* Patients must not have an active concurrent invasive malignancy. Patients with prior malignancies, including invasive colon cancer, are eligible if they are deemed by their physician to be at low risk for recurrence. Patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomization.
* Patients must be > 18 years, ECOG performance status 0 <= age <= 1.
* ANC > 1,500/µl, platelets > 100,000/µl, total bilirubin < 2.0 mg/dl or direct bilirubin < 1.0 mg/dl, alkaline phosphatase < 3xULN, ALT < 3xULN, creatinine < 1.5xULN.
* The patient must have been evaluated by a surgeon, radiation oncologist and medical oncologist and all must concur that the patient is appropriate for this study.
* Signed informed consent; able to comply with study and/or follow- up procedures
* Peripheral neuropathy < grade 1
Exclusion Criteria:
* Evidence of metastatic disease.
* Rectal cancers other than adenocarcinoma, i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, cloacogenic carcinoma, etc.
* Pregnancy or lactation at the time of proposed randomization. Eligible patients of reproductive potential (both sexes) must agree to use adequate contraception.
* Any therapy for this cancer prior to randomization.
* Synchronous invasive colon cancer.
* Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from receiving any chemotherapy treatment option or would prevent required follow-up.
* Patients with active inflammatory bowel disease, abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to Day 0 or other serious medical illness which might limit the ability of the patient to receive protocol therapy.
* Prior pelvic irradiation for any indication.
* Known hypersensitivity to 5-fluorouracil or oxaliplatin
* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
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NCT_ID
NCT01363843
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Study_NameComplete Neoadjuvant Treatment for REctal Cancer (CONTRE)
| 10,798 |
Study Objectives
This is a phase 1 open label, 4 treatment, 4 sequence and 4 period crossover study in subjects with solid tumours no longer responding to, or eligible for standard therapies, and for whom there are no additional standard therapies likely to benefit the subject.
Conditions: Malignant Solid Tumor
Intervention / Treatment:
DRUG: Olaparib Treatment A, DRUG: Olaparib Treatment B, DRUG: Olaparib Treatment C, DRUG: Olaparib Treatment D
Location: Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
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Inclusion Criteria:
* Provision of informed consent prior to any study specific procedures.
* Female or male subject, aged > 18 years.
* Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy for which no suitable effective standard therapy is available and in the opinion of the investigator might benefit from olaparib therapy.
* Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
* Haemoglobin >= 100 g/L with no blood transfusion in the past 28 days.
* Absolute neutrophil count (ANC) >= 1.5 x 109/L.
* Platelet count >= 100 x 109/L.
* Total bilirubin <= 1.5 x institutional upper limit of normal (ULN).
* Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) <= 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be <= 5x ULN.
* Subjects must have creatinine clearance estimated of >=51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test:
Estimated creatinine clearance =[(140-age [years]) x weight (kg) x 1.2] (x F)a serum creatinine (μmol/L) a where F=0.85 for females and F=1 for males
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 1.
* Subjects must have a life expectancy >= 16 weeks.
* Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
8 Male subjects must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male subjects should also use a highly effective form of contraception if they are of childbearing potential.
9 Subjects must have normal GI tract anatomy and function (see exclusion criteria for specifics).
10 Subjects is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Exclusion Criteria:
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
* Previous randomisation in the present study.
* Participation in another clinical study with an investigational product during the last 1 month.
* Any previous treatment with a PARP inhibitor, including olaparib.
* Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation > 500 ms, electrolyte disturbances, etc.) or subjects with congenital long QT syndrome.
* Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.
* Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
* Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
* Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) > grade 2) caused by previous cancer therapy, excluding alopecia.
* Subjects with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
* Subjects with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The subject can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Subjects with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
* Major surgery within 2 weeks of starting study treatment and subjects must have recovered from any effects of any major surgery.
* Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
* Subjects unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with absorption of the study medication including surgery on the upper GI tract and small bowel, malabsorptive disorders, inflammatory bowel disease, GI motility disorders, chronic diarrhea (more than 3 loose bowel movements per day) chronic constipation (no bowel movement for more than two days), recent (in last week) vomiting.
* Pregnant or breastfeeding women.
* Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus (HIV).
* Subjects with a known hypersensitivity to olaparib or any of the excipients of the product.
* Subjects with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
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NCT_ID
NCT03553108
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Study_NameA Study Using Olaparib Tablets for Subjects With Advanced Solid Tumours.
| 14,331 |
Study Objectives
Recent studies of conventional chemotherapy for infants with high-risk hematologic malignancies show that the long-term disease-free survival is low. Although blood and marrow stem cell transplantation using an HLA identical sibling has improved the outcome for these children, less than 25% have this donor source available. Another option is haploidentical transplantation using a partially matched family member donor (i.e. parental donor).
Although haploidentical transplantation has proven curative for some patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including infection and graft versus host disease (GVHD). Building on prior institutional trials, this study will provide patients a haploidentical graft depleted of T lymphocytes using the investigational device, CliniMACS selection system. One week after the transplant procedure, patients will also receive an infusion of additional donor derived white blood cells called Natural Killer (NK) cells in an effort to decrease risks for rejection of the graft, disease relapse, and regimen related toxicity. The primary objective of the study is to evaluate 1 year survival in infants with high risk hematologic malignancies who receive this study treatment.
Conditions: Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Myelodysplasia, Chronic Myeloid Leukemia, Histiocytosis
Intervention / Treatment:
DRUG: Chemotherapy and antibodies, DEVICE: Miltenyi Biotec CliniMACS, PROCEDURE: Allogeneic stem cell transplantation
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
Must have one of the following diagnosis:
* AML in remission or relapse (e.g., FAB M7 or biphenotypic leukemia)
* High-risk ALL in first remission (e.g., poor responder to prednisone, Ph+ ALL)
* ALL beyond first remission
* Secondary leukemia
* Primary myelodysplasia (including RAEB, RAEB-T, CMML, JCML, and JMML)
* Chronic myeloid leukemia
* Histiocytoses (including multi-system Langerhans' cell histiocytosis and hemophagocytic lymphohistiocytosis
Inclusion criteria Donor research participants
* HIV negative (date).
* Hepatitis B surface antigen negative (date).
* Hepatitis C antibody negative (date).
* Syphilis negative (date).
* Donor is equal to or greater than 3 on 6 HLA match (date).
* Not pregnant (negative pregnancy test).
* Not lactating.
* At least 18 years.
Exclusion Criteria
* Patients greater than 24 months of age at the time of transplant.
* HLA-identical sibling donor is available.
* Cardiac function: shortening fraction <25%.
* Pulse oximetry oxygen saturation <92% on room air.
* Glomerular filtration rate less than 40 ml/min/1.73 m2 (may use Technetium-99 result for GFR).
* Direct bilirubin > 3 mg/dl.
* SGPT > 500 U/L.
* Patients with previous allergy to mouse proteins.
* Patients with previous allergy to rabbit serum products.
* Patients with Down's syndrome
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NCT_ID
NCT00145626
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Study_NameHLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies
| 14,697 |
Study Objectives
Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood vessels (a process called "angiogenesis"). This can reduce blood flow of the tumor and then decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the tumor from growing.
In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already benefits from a marketing authorization (MMA) for these various types of cancers.
The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is ended.
This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal since this tumors are very well vascularized.
The ALIENOR study aims to explore the interest and the clinical benefit of associating bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords- stromal tumor treated beforehand by platinum chemotherapy
Conditions: Ovarian Sex-cord Stromal Tumor
Intervention / Treatment:
DRUG: Paclitaxel, DRUG: Bevacizumab
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Female aged >= 18 years at inclusion
* Histologically confirmed diagnosis of ovarian Sex cord-stromal tumors including the following cell types: granulosa cell tumours (adults and juveniles types), granulosa cell-theca cell tumour, Sertoli-Leydig cell tumours, malignant steroid cell tumours, gynandroblastoma, unclassified SCST and mixed tumours
* Documented relapse of SCST defined by progression of disease (radiologic, clinic or biological progression)
* At least one measurable site of disease as defined by RECIST 1.1
* Tumours within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence > 90 days following completion of radiotherapy.
* Patients must have been pre-treated with at least 1 prior line of platinum-based chemotherapy
* Adequate bone marrow, liver and renal functions including the following:
* Absolute neutrophil count >= 1.5 G/L, platelet count >= 100 G/L, and hemoglobin >= 9 g/dL. Prior transfusion is authorized to keep haemoglobin level to >=9g/dL
* AST/ALT <= 3 x upper limit of normal (ULN) (or <= 5.0 ULN if liver metastasis) and total bilirubin <= 1.5 ULN
* Serum creatinine <= 1.5 ULN or calculated creatinine clearance >= 50 mL/min according to Cockcroft formula (or to MDRD formula for patients older than 65 years-old).
* Adequate coagulation panel:
* PT <= 1.2 ULN
* aPTT <= 1.5 ULN
* INR <= 1.5 ULN
* Adequate neurologic function: only neuropathy (sensory and motor) grade <= 1 (CTCAE v4.3) are allowed
* ECOG Performance status of 0, 1, or 2 (Appendix 5)
* Life expectancy >= 4 months
* Satisfactory cardiac function
* Ability to understand and sign informed consent and willingness to comply with the study procedures before study entry
* Women of childbearing potential* are required to have a negative serum pregnancy test within 7 days prior to study treatment initiation (i.e. Cycle 1 Day 1) and are willing to use adequate contraceptive method during the whole study period and for up to 6 months after the last treatment intake
*: Female patients who meet at least one of the following criteria are defined as women of non-childbearing potential:
* >= 50 years and naturally amenorrheic for >= 1 year
* Permanent premature ovarian failure confirmed by a specialist gynaecologist
* Previous bilateral salpingo-oophorectomy or hysterectomy
* XY genotype, Turner's syndrome, or uterine agenesis
* Female patient who do not meet at least of the above criteria are defined as women of childbearing potential
* Covered by a medical insurance (in country where applicable)
Exclusion Criteria:
* Prior systemic therapy with bevacizumab
* Active peripheral neuropathy >= grade 3 (NCI-CTCAE v4.3)
* Prior history of other malignancies other than ovarian SCST (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the subjects has been free of the disease for at least 3 years or 5 years for breast cancer
* No resolution of specific toxicities related to any prior anti-cancer therapy to grade <=1, excluding alopecia, according to the NCI-CTCAE v.4.3
* History or evidence of thrombotic or hemorrhagic disorders, including cerebro-vascular accident/stroke or transient ischemic attack or sub-arachnoids' haemorrhage within 6 months prior to first dose of study drugs
* Uncontrolled arterial hypertension (systolic >= 150 mmHg or diastolic >= 100 mmHg) despite optimal antihypertensive therapy or clinically significant cardiovascular disease including one of the following:
* Myocardial infarction or instable angina within 6 months prior to first dose of study drugs
* NYHA grade >= II congestive heart failure
* Serious cardiac arrhythmia requiring medication
* Peripheral vascular disease >= grade 3
* History of bowel obstruction, including sub-occlusive syndrome and history of abdominal fistula, gastro-intestinal perforation or intra-abdominal abscess during the year prior to inclusion
* Prior treatments:
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study inclusion or anticipation of need for major surgical procedure during the course of the study
* Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or within 6 weeks in case of prior nitrozo-urea and or mitomycin C treatment. In case of hormonotherapy , patients will be eligible if hormonotherapy is discontinued within at least 1 week before treatment initiation
* Current or recent (within 10 days prior to randomization) chronic use of aspirin> 325 mg/day or use of any other inhibitor of platelet aggregation
* Chronic treatment (i.e. > 15 days) with non steroids anti-inflammatory agents unless a washout period of 15 days was observed before the inclusion.
* Intake of granulocyte growth factor within 3 weeks before study entry
* Presence of hematuria and proteinuria >= 2+ (urine dipstick). Patients with >= 2+ proteinuria on dipstick at screening should undergo a 24-hour urine collection and will be eligible only if 24-h proteinuria <= 1 g
* Untreated evolutive brain metastases
* Active bacteria or fungal infection (grade >=2, CTC AE V4.3)
* Known HIV1, HIV2 or chronic hepatitis B or C infection
* Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies
* Any contraindications to paclitaxel treatment: for example severe hypersensitivity reactions to paclitaxel, macrogolglycerol ricinoleate (polyoxyl castor oil) or to any of the excipients (Ethanol Citric acid) (refer to Taxol® SPC for further details)
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NCT_ID
NCT01770301
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Study_NameEfficacy and Safety of Bevacizumab (Avastin®) Combined to Weekly Paclitaxel Followed by Bevacizumab (Avastin®) Alone in Patients With Relapsed Ovarian Sex-cord Stromal Tumours (ALIENOR)
| 11,346 |
Study Objectives
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or colorectal cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib hydrochloride and cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with cetuximab may kill more tumor cells.
Conditions: Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Gastrointestinal Stromal Tumor, Metastatic Gastrointestinal Carcinoid Tumor, Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Adult Primary Liver Cancer, Recurrent Anal Cancer, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Colon Cancer, Recurrent Esophageal Cancer, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Recurrent Gastric Cancer, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Non-small Cell Lung Cancer, Recurrent Pancreatic Cancer, Recurrent Rectal Cancer, Recurrent Salivary Gland Cancer, Recurrent Small Intestine Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Small Intestine Adenocarcinoma, Small Intestine Leiomyosarcoma, Small Intestine Lymphoma, Stage IV Adenoid Cystic Carcinoma of the Oral Cavity, Stage IV Anal Cancer, Stage IV Basal Cell Carcinoma of the Lip, Stage IV Colon Cancer, Stage IV Esophageal Cancer, Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Stage IV Gastric Cancer, Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Stage IV Lymphoepithelioma of the Nasopharynx, Stage IV Lymphoepithelioma of the Oropharynx, Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Stage IV Mucoepidermoid Carcinoma of the Oral Cavity, Stage IV Non-small Cell Lung Cancer, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity, Tongue Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer
Intervention / Treatment:
DRUG: cetuximab, DRUG: erlotinib hydrochloride, OTHER: laboratory biomarker analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed incurable gastrointestinal tract, head and neck, or non-small cell lung cancers that are KRAS wild type; if KRAS mutational status cannot be determined on archived tumor tissue from the patient, a needle or excisional biopsy of a malignant site may be performed prior to enrollment; mutational status may be determined either by polymerase chain reaction (PCR) assay (e.g., DxS KRAS mutation kit) or by direct sequencing of KRAS exon 2, codons 12 and 13; the result must detect no mutations at these sites
* Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
* Leukocytes >= 3,000/mcL
* Absolute neutrophil count >= 1,500/mcL
* Platelets >= 100,000/mcL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
* Creatinine within normal institutional limits or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
* Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of erlotinib will be determined following review of their case by the principal investigator; although concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers is not prohibited in this study, identification of MTD and DLT may be affected by their use; concomitant use of any of these drugs will be noted in the case report forms and will be taken into account in determining MTD and DLT of this therapy; efforts should be made to switch patients with a history of brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Other prior malignancies are allowed provided prior therapy has been discontinued and there is no evidence of disease (NED)
* Patients must be able to take and retain oral medications
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients may not be receiving any other investigational agents
* Patients with a history of brain metastases are eligible provided that the metastases have been surgically resected and/or are radiographically and clinically stable for 2 months following the completion of radiation therapy
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab
* Prior treatment with EGFR-targeting therapies
* Major surgery or significant traumatic injury occurring within 21 days prior to treatment
* Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
* Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with erlotinib or cetuximab
* Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study
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NCT_ID
NCT00397384
|
Study_NameErlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer
| 8,973 |
Study Objectives
This retrospective cohort study will assess the association of benign prostatic hyperplasia (BPH) treatment (5-alpha reductase inhibitors (5ARI) and alpha-blocker medications) with the occurrence of prostate cancer related mortality. This study will also assess a number of secondary endpoints including prostate cancer mortality or metastatic prostate cancer, and all cause mortality.
Conditions: Prostatic Hyperplasia
Intervention / Treatment:
OTHER: 5-alpha reductase inhibitors, OTHER: Alpha-blockers
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Patients that are Male
* Patients that have a new prescription for BPH medication (5ARI and/or alpha-blocker) in 1992 or later that is identified as appropriate treatment for BPH/LUTS from the KP National Pharmacy guidelines.
* Patients with a treatment with BPH medication must be initiated prior to Jan1, 2008.
* Patients age >= 50 years at time of treatment with 5ARI or alpha-blocker.
* Patients with at least 1-year of coverage in the healthcare system before the first prescription for BPH medication (5ARI and/or alpha-blocker).
* Patients with at least 3 consecutive prescriptions (90 days of supply) for a BPH medication (5ARI and/or alpha-blocker).
Exclusion Criteria:
* Patients with a diagnosis of prostate cancer any time before the first prescription for BPH medication (5ARI and/or alpha-blocker).
* Patients with a dagnosis of prostate cancer within 3 months after first BPH medication (5ARI and/or alpha-blocker)
* Patients treated with Finasteride 1mg prior to BPH medication. Finasteride 1mg is the dose approved for androgenic alopecia and as the target population for this study is men with treated BPH, we will exclude all men treated with the 1mg dose.
|
NCT_ID
NCT01767363
|
Study_NameWEUSKOP5723: Prostate Cancer Study
| 2,948 |
Study Objectives
Sorafenib is a drug being studied for the treatment of cancer. Sorafenib has been shown to block certain proteins on the surface of some cancer cells called "growth factor receptors." Blocking these growth factor receptors can slow or stop cancer cell growth.
Sorafenib is also known as Nexavar®. It has been studied in other types of cancers, including kidney cancer, and has been approved by the Food and Drug Administration (FDA) for treating advanced kidney cancer. Because it is not approved by the FDA for treating esophageal cancer, it is considered an experimental treatment.
The purpose of this study is to determine what effects sorafenib has on advanced esophageal cancer. These effects include whether sorafenib can shrink the tumor or slow down its growth and what side effects sorafenib will have on the tumor.
Conditions: Esophageal Cancer, Gastroesophageal Junction Cancer
Intervention / Treatment:
DRUG: Sorafenib, administered orally, PROCEDURE: CT/MRI
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must have histologically proven or cytologically confirmed esophageal cancer (squamous cell carcinoma or adenocarcinoma) or adenocarcinoma of the gastroesophageal (GE) junction documented at MSKCC.
* Metastatic disease measurable on a CT or MRI scan. Locally recurrent disease that is not amenable to potentially curative surgery or radiation therapy is also allowed. Lesions must be >= 10 mm in size. The primary tumor is not considered measurable disease. Recurrent or metastatic lesions within a prior radiation field are acceptable as long as disease has progressed in the radiation field by RECIST criteria. The same imaging modality performed at baseline (CT or MRI) will be repeated at subsequent imaging.
* Patients are allowed to have a maximum of two prior chemotherapy regimens for metastatic disease. Patients are allowed to have a maximum of three prior regimens if they also previously received neoadjuvant/adjuvant chemotherapy or chemoradiotherapy. The last treatment must have been administered > 3 weeks prior to initiation of therapy with sorafenib.
* Pathologic tissue must be available for immunohistochemistry (IHC) staining for phosphorylated extracellular signal-regulated kinase (pERK). Both patients with and without pERK staining are eligible for treatment. Submission of slides and IHC testing for pERK may be done during the course of therapy and are not required prior to protocol therapy.
* Age >= 18 years.
* Life expectancy > 3 months.
* Karnofsky performance status >= 60%.
* Patients must have the ability to comprehend and willingness to sign an informed consent document.
* At baseline, patients must have normal organ and marrow function as defined:
* Adequate bone marrow, liver and renal function as assessed by the following:
* Hemoglobin >= 9.0 g/dl
* Absolute neutrophil count (ANC) >= 1,500/mm3
* Platelet count >= 100,000/mm3
* Total bilirubin <= 1.5 times ULN
* ALT and AST <= 2.5 times the ULN ( < or = to 5 x ULN for patients with liver involvement)
* Creatinine <= 1.5 times ULN
Exclusion Criteria:
* Patients who have not recovered from adverse events related to therapy administered > 3 weeks earlier. This does not include hemoglobin or other hematologic or laboratory criteria.
* Patients may not be receiving any other investigational agents.
* Prior therapy with sorafenib-related compounds or compounds of similar biologic or chemical components, including compounds targeting VEGF, VEGF-R or RAF kinase.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, greater than New York Heart Association (NYHA) Class II congestive heart failure, unstable or new onset angina pectoris or myocardial infarction within the past six months, unstable arrhythmia, or psychiatric illness/social situation, e.g., severe schizophrenia, that would limit compliance with study requirements. Patients with chronic arrhythmias, such as paroxysmal atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible.
* Uncontrolled hypertension, defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, despite optimal medical management.
* Thrombotic or embolic event, including cerebrovascular accident or transient ischemic attack within the past six months. Patients with prior deep vein thromboses or pulmonary emboli on a stable anticoagulation regimen will be eligible for enrollment.
* Any factor that would significantly interfere with the inability to consume or absorb an oral medication, e.g. severe nausea/vomiting not controlled by an aggressive anti-emetic regimen, grade 3/4 dysphagia, extensive small bowel resection or active inflammatory bowel disease leading to chronic malabsorption. Patients with enteral feeding tubes are eligible as sorafenib can be crushed.
* Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C infection.
* Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.
* Patients who are taking St. John's wort or rifampin (as there may be drug-drug interactions with sorafenib.
* Patients with known brain metastases or meningeal carcinomatosis are excluded. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
* Pregnant women are excluded because sorafenib has the potential for teratogenic or abortifacient effects. Female patients must either not be of childbearing potential or must have a negative pregnancy test <= 7 days prior to treatment. Female patients are considered not of childbearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or if they are post-menopausal. Men must use effective birth control if their partners are of child-bearing potential.
* No other malignancy is allowed except for adequately treated carcinoma in-situ of the cervix, superficial transitional cell carcinoma of the bladder or basal/squamous cell skin cancer. Other cancers are permissible if the patient has been disease free for >= 3 years.
* Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks of first dose of study drug.
* Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 4 weeks of first dose of study drug.
* Serious non-healing wound, ulcer, or bone fracture.
* Evidence or history of bleeding diathesis or coagulopathy.
* Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
* Known or suspected allergy to sorafenib or any agent given in the course of this trial.
|
NCT_ID
NCT00917462
|
Study_NameSorafenib for Patients With Metastatic or Recurrent Esophageal and Gastroesophageal Junction Cancer
| 5,597 |
Study Objectives
BRF112680 is a first-time-in-human study to establish the recommended dose and schedule of the orally administered GSK2118436. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after the treatment of subjects with solid tumors. This is a two-part study. Part 1 will identify the recommended Part 2 dose using a dose-escalation procedure. Escalation may proceed until either a maximum tolerated dose is established, or the toxicokinetic safety limit is reached. The recommended Part 2 dose will be expanded to up to 12 patients. Part 2 will explore further the safety, tolerability, and clinical activity of GSK2118436 in subjects with BRAF mutation-positive tumors. In addition, the effect of GSK2118436 on midazolam will be assessed in a subset of patients in Part 2. Biologically active doses will be identified by measurement of pharmacodynamic markers in tumor tissue and blood across a range of doses and these doses may be explored in Part 2.
Conditions: Cancer
Intervention / Treatment:
DRUG: GSK2118436, DRUG: GSK2118436, DRUG: Midazolam
Location: United States, Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Written informed consent provided.
* 18 years or older. Subjects enrolled in the midazolam cohort need to be younger than 65 years.
* Histologically or cytologically confirmed diagnosis of a solid tumor that is not responsive to standard therapies or for which there is no approved or curative therapy. Subjects must have BRAF mutant positive tumors.
* Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
* Able to swallow and retain oral medication.
* Male subjects must agree to use one of the contraception methods listed in the protocol. The criterion must be followed from the time of the first dose of study medication until 16 weeks after the last dose of study medication.
* A female subject is eligible to participate if she is of non-childbearing potential or postmenopausal as defined in the protocol. A female of child-bearing potential may participate if she agrees to use one of the contraception methods listed in the protocol.
* Adequate organ system function as defined in the protocol.
* Part 2/Cohorts A, B and C: Must have radiologically and/or clinically documented disease with at least one measurable lesion as defined by RECIST criteria.
* Part 2/Cohort C only: Must have BRAF positive melanoma with the V600E mutation.
Exclusion Criteria:
* Currently receiving cancer therapy (chemotherapy, radiation therapy, immuno-therapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization).
* Use of an investigational anti-cancer drug within 28 days preceding the first dose of GSK2118436.
* Current use of a prohibited medication as defined in the protocol or requires any of these medications during treatment with GSK2118436.
* Current use of therapeutic warfarin.
* Any major surgery, radiotherapy, or immunotherapy within 4 weeks prior to first dose. Limited radiotherapy within 2 weeks prior to first dose.
* Chemotherapy regimens with delayed toxicity within four weeks prior to first dose (6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within 2 weeks prior to first dose.
* Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 Grade 1 from previous anti-cancer therapy except alopecia unless agreed to by a GSK Medical Monitor and the investigator.
* Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
* A history of known HIV infection.
* Primary malignancy of the central nervous system.
* Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Subjects previously treated for these conditions that are asymptomatic and off corticosteroids for at least two weeks are permitted. Brain metastases must be stable for at least 3 months with verification by imaging (brain MRI completed at screening). Subjects are not permitted to receive enzyme inducing anti-epileptic drugs (EIAEDs). In Part 2 of the study, subjects with asymptomatic, untreated brain metastases that have not been stable for 3 months may be enrolled with approval of the GSK medical monitor. These subjects can be on a stable dose of corticosteroids.
* History of alcohol or drug abuse within 6 months prior to the screen visit.
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
* Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
* QTc interval greater than or equal to 480 msecs.
* History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within 24 weeks prior to the first dose.
* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
* Abnormal cardiac valve morphology (subjects with minimally abnormalities can be entered on study with approval from the GSK medical monitor).
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug, or excipients as described in the protocol (to date there are no known FDA approved drugs chemically related to GSK2118436).
* Pregnant or lactating female.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Subjects with known glucose 6 phosphate dehydrogenase (G6PD) deficiency.
* Patients positive for HPV. Entry on study allowed only at the discretion of subject and investigator after informed consent regarding discussion of the risk of papillomavirus infection. If enrolled, these subjects must use condoms for sexual activity, regardless of the use of other contraceptive measures and childbearing status.
* Prior treatment with a BRAF or MEK inhibitor unless approved by the GSK medical monitor.
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NCT_ID
NCT00880321
|
Study_NameA Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors
| 16,672 |
Study Objectives
The study was set up to assess:
1. Standard-dose versus high-dose remission induction therapy. A standard ICE chemotherapy vs sequential high-dose cytarabine, with appropriate supportive/prophylactic measures, followed by morphological, cytogenetic and molecular monitoring of remission.
2. A risk-oriented postremission therapy: HR patients will be electively submitted to allogeneic stem cell transplantation (allo-SCT), whenever possible (related/unrelated donor/cord blood; ablative/non-ablative conditioning according to national and local protocols and guidelines). Provided sufficient blood stem cells were previously collected (\>2x10e6/kg Cluster of Differentiation 34 cells), SR patients and HR patients excluded from allo-SCT and aged 65 years or less will be randomized to: myeloablative autologous blood stem cell transplantation vs non-myeloablative, multicycle, autologous blood stem cell-supported high-dose cytarabine-based therapy.
* HR/SR patients unable to be randomized because of inadequate blood stem cell yield will receive intermediate-dose consolidation; patients aged \>65 years will be treated with age-adapted therapy.
Conditions: Acute Myelogenous Leukemia
Intervention / Treatment:
DRUG: cytosine arabinoside
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion criteria (Random 1):
* Age 16+ years
* Diagnosis of untreated (or only hydroxyurea/cyclophosphamide) acute myelogenous leukemia (AML, including myeloid sarcoma) or high-risk myelodysplasia (RAEB-2), either de novo or following an antecedent hematological disorder, or secondary to chemo-radiotherapy for other cancer
* Signed informed consent
* Adequate sampling for full cytological, cytochemical, cytogenetic and immunobiological disease characterization by revised FAB, EGIL and WHO criteria
* ECOG performance status 0 <= age <= 2 or reversible ECOG 3 score following intensive care of complications.
Exclusion criteria:
* Diagnosis of acute promyelocytic leukemia
* Pre-existing, uncontrolled pathology such as cardiac disease (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrythmias, NYHA classes III and IV), severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to AML), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to AML), and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan
* Known HIV positive serology
* Other active hematological or non-hematological cancers with life expectancy <1 year
* Pregnancy (fertile women will be advised not to become pregnant while on treatment; and male patients to adopt contraceptive methods)
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NCT_ID
NCT00495287
|
Study_NameA Remission Induction Therapy and Risk-oriented Postremission Strategy for Adult Acute Myelogenous Leukemia (AML)
| 18,417 |
Study Objectives
The purpose of this study is to evaluate the safety and activity of gemcitabine plus trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)+ breast cancer who have progressed on at least one prior line of chemotherapy plus HER2 targeted agent such as T-DM1, trastuzumab, or lapatinib.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Gemcitabine, DRUG: Trastuzumab, DRUG: Pertuzumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Adult males or females (aged >= 18 years) with histologically confirmed, metastatic human epidermal growth factor receptor 2 (HER2)+ (by immunohistochemistry (IHC) 3+ or fluorescence in situ hydridization (FISH) ratio >= 2.0) breast cancer
* Have progressed on at least one prior line of chemotherapy plus HER2 directed therapy such as trastuzumab and/or pertuzumab in the metastatic setting. T-DM1 would count as a line of therapy and patients previously treated with T-DM1 are eligible.
* Have not been treated with gemcitabine in the metastatic setting
* Measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 2<=
* Left Ventricular Ejection Fraction (LVEF) >= 50% at baseline as determined by either echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
* Adequate bone marrow function as indicated by the following: absolute neutrophil count (ANC) >1500/µL; Platelets >=100,000/µL; Hemoglobin >10 g/dL
* Adequate renal function, as indicated by creatinine <=1.5x upper limit of normal (ULN)
* Adequate liver function, as indicated by bilirubin <=1.5x ULN, aspartic transaminase (AST) or alanine transaminase (ALT) <2x ULN unless related to metastatic breast cancer to the liver (in which case AST/ALT < 5x ULN is allowed).
* Signed informed consent
* Adequate birth control in sexually active women of childbearing potential
Exclusion Criteria:
* Active uncontrolled infection or major concurrent illness which in the opinion of the investigator would render the participant unsafe to proceed with the study
* Uncontrolled central nervous system (CNS) metastases. Treated, non-progressing CNS disease (documented by brain magnetic resonance imaging [MRI]) off corticosteroids for at least 1 month potential participants are eligible.
* Women who are pregnant or lactating
* Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin)
* Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation)
* Other concomitant active malignancies
* History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
* Ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower
* Hypersensitivity to any of the study medications
* Untreated psychiatric conditions preventing informed consent
|
NCT_ID
NCT02139358
|
Study_NamePhase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer
| 4,448 |
Study Objectives
Gemcitabine is usually used to treat cancer of the pancreas. The purpose of this study is to determine if Kanglaite Injection (KLT) is safe in patients with cancer of the pancreas, and whether it improves the effectiveness of gemcitabine. Additionally, the effect, if any, of KLT on the signs and symptoms of cancer as well as the common side effects of chemotherapy will be evaluated.
The research drug, KLT, is purified from a traditional Chinese medicine called coix seed. It is approved in China for use in combination with chemotherapy to treat patients with advanced lung cancer and liver cancer. It is also approved in China for use by itself to treat the symptoms of cancer in patients with advanced cancer of any kind. In the US, KLT is purely experimental and is not approved for any use. While a small number of cancer patients in the US have received KLT alone in a Phase I study, this is the first US protocol to evaluate whether or not KLT is useful in pancreatic cancer.
This phase II clinical study was completed in the US in June 2014. The clinical study report was submitted to the FDA in January 2015. The designs of the phase III clinical study for KLT has been cleared by the FDA in May 2015 and will be launched soon.
Conditions: Pancreatic Cancer
Intervention / Treatment:
DRUG: Kanglaite Injection plus gemcitabine, DRUG: Gemcitabine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Must have a life expectancy of at least 84 days (12 weeks)
* Must be ambulatory and have either a Karnofsky performance status of 60 or higher or ECOG performance status of 0, 1 or 2
* Must have histologically confirmed pancreatic cancer, either locally invasive or metastatic, and not amenable to potentially curative resection
* Must have measurable or evaluable target lesions, by RECIST 1.1 criteria
* Must not have previously received chemotherapy for metastatic disease
* If female, must have negative pregnancy test, be at least one year post menopausal, or have undergone surgical sterilization and must be willing to use appropriate birth control measures unless post menopausal or post surgical sterilization
* Must be judged by the Investigator to have the initiative and means to be compliant with the protocol including the return for follow-up visits on schedule
* Must give written informed consent prior to any testing under this protocol
* Must have Hemoglobin > 9 gm/dl, WBC>2 x109/ml, and platelets >100,000/ul
* Must have Alkaline Phosphatase < 2.5 x ULN, ALT < 2.0 x ULN, AST< 2.0 x ULN and bilirubin < 2.0
* Must have stable renal function appropriate for age. A patient must have a serum creatinine of < 1.5mg/dl or a GFR > 60 mL/minute
* Must have a central venous catheter if randomized to the G + K arm of study, or if the patient does not have one, must agree to have one placed if randomized to the G+K arm.
Exclusion Criteria:
* Patient has a history of cancer within 5 years other than pancreatic cancer (excluding resected non melanoma skin carcinoma
* Patient has active (untreated or still receiving corticosteroids) brain metastases
* Patient has had prior chemotherapy for metastatic disease
* Patient has received prior gemcitabine < 12 months previously
* Patient is currently taking a bile acid sequestrant drug (such as Questran, Colestid or Welchol) or a fibric acid derivative drug (such as Lopid, Tricor, Antara, Lofibra and Trilipix) - Patients with disturbances of lipid metabolism such as pathologic hyperlipidemia (including congenital hypertriglyceridemia or cholesterolemia), lipoid nephrosis, or acute pancreatitis
* Patient has uncontrolled Type 1 or 2 diabetes mellitus
* Patient has another active medical condition(s) or organ disease(s) that may either compromise patient safety or interfere with the safety and/or outcome (e.g., survival) evaluation of the study drugs
* Patient or physician plans surgical treatment of malignancy, radiation therapy, or biological treatment for cancer including immunotherapy while on study, other than surgical bypass or stent insertion for relief of bile flow blockage
* Patient has a known allergy to soybeans (used in production of Kanglaite Injection) or Job's Tear (source of active ingredient of Kanglaite Injection), or to gemcitabine
* Patient has NYHA congestive heart failure Class II or higher from any cause
* Patient has unstable angina or history of an MI within 12 months
* Patient is pregnant or lactating
* Patient has used or plans to use another investigational agent within four weeks prior to screening through the entire study period including study termination and the follow-up visits.
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NCT_ID
NCT00733850
|
Study_NameSafety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer
| 14,479 |
Study Objectives
The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.
Conditions: Metastatic Castration-Resistant Prostate Cancer
Intervention / Treatment:
DRUG: Abemaciclib
Location: France, United States, Spain
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Participant must have metastatic prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant).
* Participant must have disease spread to soft tissue that is measurable.
* Participant must have documented evidence of progressive disease by PSA test or imaging.
* Participant must have previously received at least one of the following treatment: abiraterone acetate, apalutamide, darolutamide or enzalutamide.
* Participant must have previously received chemotherapy with docetaxel and cabazitaxel.
* Participant must be willing and amenable to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research.
* Participant must have good physical functioning ability and adequate organ function.
Exclusion Criteria:
* Participant must not have received more than 3 therapy regimens for metastatic castration-resistant prostate cancer (NOTE: GnRHa, first-generation antiandrogens (flutamide, nilutamide, or bicalutamide), diethylstilbestrol (DES) (or other estrogens), corticosteroids, ketoconazole, and bone loss-prevention will not count as systemic therapy regimens.
* Participants must not have previously received abemaciclib or any cyclin-dependent kinase (CDK)4 and/or CDK6 inhibitors.
* Participants must not have serious and/or uncontrolled preexisting medical condition(s) including but not limited to severe renal impairment, severe hepatic impairment, interstitial lung disease (ILD)/pneumonitis, severe dyspnea at rest or requiring oxygen therapy or other serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
* Participants must not have, or suspected to have, brain metastasis.
* Participants must not have untreated spinal cord compression, evidence of spinal metastases with risk of spinal compression or structurally unstable bone lesions suggesting impending fracture.
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NCT_ID
NCT04408924
|
Study_NameAbemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
| 7,305 |
Study Objectives
GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line chemotherapy in metastatic pancreatic cancer patients.
The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30 min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for three weeks followed by one week of rest.
Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then at 2 mg/kg over 30 min. for the subsequent infusions.
Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.
The patients will be subjected to research for the EGFR, HER2 and KRAS status.
Conditions: Metastatic Pancreatic Adenocarcinoma
Intervention / Treatment:
DRUG: Gemcitabine - Trastuzumab - Erlotinib
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Metastatic pancreatic adenocarcinoma confirmed by histology
* Tumor sample available
* Measurable lesion according to RECIST criteria
* Performance status >= 1
* Life expectancy > 3 months
* Hematology: Hb >= 9g/dL, neutrophils >= 1,500/mm3, platelets >= 100,000/mm3
* Renal function: creatinine <= 1.5 x ULN
* Hepatic function: total bilirubin <= 2.5 x ULN, transaminases <= 5 x ULN
* Left ventricular ejection fraction (LVEF) >= 50%
* At least a 6-month delay between the end of any previous gemcitabine-based chemotherapy and diagnosis of metastases
* Social security
* Informed consent obtained prior to inclusion.
Exclusion Criteria:
* Non metastatic advanced local disease
* Presence of cerebral metastases or symptomatic leptomeningeal carcinomatosis
* Others cancers except BBC and cervical cancer receiving curative treatment
* No previous treatment by Erlotinib or Trastuzumab
* Known severe hypersensitivity to Erlotinib, Trastuzumab, murine proteins or Gemcitabine
* Presence of significant co-morbidities
* Concomitant treatment with other experimental products or other anticancer therapies
* Breastfeeding or pregnant female, or patient of reproductive age not using adequate contraception
* Legal incapacity or limited legal incapacity
|
NCT_ID
NCT01204372
|
Study_NameTrial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma
| 9,578 |
Study Objectives
This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body.
In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
Conditions: Metastatic Colorectal Adenocarcinoma
Intervention / Treatment:
DRUG: Trastuzumab, DRUG: Tucatinib
Location: United States, Spain, Italy, Belgium, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria
* Histologically and/or cytologically documented adenocarcinoma of the colon or rectum that is metastatic and/or unresectable
* Unless contraindicated, participants must have received and failed regimens containing the following agents: fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ramucirumab, or ziv-aflibercept), and an anti-PD-(L)1 therapy (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins or is MSI-High.
* Have progression of unresectable or metastatic CRC after the last systemic therapy, or be intolerant of last systemic therapy
* Have RAS wild-type in primary or metastatic tumor tissue, based on expanded RAS testing
* Willing and able to provide the most recently available tissue blocks obtained prior to treatment initiation. If archival tissue is not available, then a newly-obtained baseline biopsy of an accessible tumor
* Have confirmed HER2-positive mCRC, as defined by having tumor tissue tested at a Clinical Laboratory Improvement Act (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory, meeting at least one of the following criteria:
* HER2+ overexpression (3+ immunohistochemistry [IHC]) by an FDA-approved or Conformité Européene (CE)-marked HER2 ICH test
* HER2 2+ IHC is eligible if the tumor is amplified by an FDA-approved or CE-marked HER2 in situ hybridization assay (FISH or chromogenic in situ hybridization [CISH]))
* HER2 (ERBB2) amplification by CLIA-certified or ISO-accredited next generation sequencing (NGS) sequencing assay
* Have radiographically measurable disease assessable by RECIST 1.1, with at least one site of disease that is measurable and that has not been previously irradiated; or, if the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Life expectancy greater than 3 months
* Have adequate hematological, hepatic, renal, coagulation, and cardiac function
Exclusion Criteria
* Previous treatment with anti-HER2 targeting therapy
* Previous treatment with any systemic anticancer therapy, non-central nervous system radiation, or experimental agent within 3 weeks of first dose of study treatment
* Toxicity related to prior cancer therapies that has not resolved to <= Grade 1, with the following exceptions:
* Alopecia and neuropathy, which must have resolved to <= Grade 2
* Congestive heart failure (CHF), which must have been <= Grade 1 in severity at the time of occurrence, and must have resolved completely
* Anemia, which must have resolved to <= Grade 2
* Decreased ANC, which must have resolved to <= Grade 2
* Have clinically significant cardiopulmonary disease
* Have known myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery within 6 months prior to first dose of study treatment
* Major surgical procedure, open biopsy, or significant traumatic injury <=28 days prior to enrollment (<=56 days for hepatectomy, open thoracotomy, or major neurosurgery) or anticipation of need for major surgical procedure during the study
* Serious, non-healing wound, ulcer, or bone fracture
* Known to be positive for hepatitis B by surface antigen expression
* Known to have active hepatitis C infection
* Exception for participants with a documented sustained virologic response of 12 weeks
* Known to be positive for human immunodeficiency virus (HIV)
* Subjects who are pregnant, breastfeeding, or planning a pregnancy
* Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications
* Have used strong CYP2C8 inhibitor within 5 half-lives of the inhibitor, or have used a strong CYP2C8 or CYP3A4 inducer within 5 days prior to first dose of study treatment
* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
* Exceptions are malignancies with a negligible risk of metastasis or death
* Subjects with known active CNS metastasis
* Irradiated or resected lesions are permitted, provided the lesions are fully treated and inactive, subject is asymptomatic, and no steroids have been administered for at least 30 days
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NCT_ID
NCT03043313
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Study_NameTucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer
| 7,553 |
Study Objectives
The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.
Conditions: Breast Cancer, Anemia
Intervention / Treatment:
DRUG: Darbepoetin Alfa, DRUG: Recombinant Human Erythropoietin
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria: - Female subjects receiving multi-cycle chemotherapy - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV) infection
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NCT_ID
NCT00120692
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Study_NameTreatment for Patients Suffering From Anemia Due to Chemotherapy
| 5,059 |
Study Objectives
This phase I/II trial studies the best dose and effect of pimasertib in combination with bintrafusp alfa in treating patients with cancer that has spread to the brain (brain metastases). Immunotherapy with bintrafusp alfa, a bifunctional fusion protein composed of the monoclonal antibody anti-PD-L1 and TGF-beta, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pimasertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pimasertib and bintrafusp alfa may help to prevent or delay the cancer from progressing (getting worse) and/or coming back.
Conditions: Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Hematopoietic and Lymphoid Cell Neoplasm, Hormone Receptor Positive Breast Adenocarcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Triple-Negative Breast Carcinoma, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Intervention / Treatment:
DRUG: Bintrafusp Alfa, DRUG: Pimasertib, OTHER: Quality-of-Life Assessment
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Age >= 18 years
* Life expectancy > 12 weeks
* Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
* At least one measurable untreated brain lesion >= 0.5 cm and < 3.0 cm in the longest axis according to modified RECIST 1.1
* Prior stereotactic radiosurgery (SRS) with up to 3 lesions treated with at least a 14 day interval is allowed as long as the previous treatment volume does not overlap with the current targets
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
* Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy in the 10 days prior to beginning protocol therapy
* Prior treatment with immunotherapy and targeted therapy allowed as long as it did not include a combination of MEK inhibitor (i) + anti-PD(L)-1 antibody and is > 14 days prior to start of protocol therapy. All tumor types will be eligible and included in the dose escalation phase. Dose expansions will include 10 patients each from lung, breast, and melanoma
* Patients with melanoma must have received prior PD-1 based therapy and have evidence of progression
* Patients with non-small cell lung cancer (NSCLC) must have received prior PD-1 based therapy and have evidence of progression
* Patients with triple-negative breast cancer (TNBC) and hormone receptor positive (HR+) are included (any number of prior lines of therapy-including immuno-oncology [IO] naive patients)
* For HR+ patients, patients are allowed to receive endocrine therapy with or without CDK4/6 inhibitors per treating physician discretion (Arimidex, letrozole, exemestane, or fulvestrant)
* Systematic radiation therapy is allowed (> 14 day washout)
* Prior platinum-based chemotherapy for NSCLC patients is allowed
* Absolute neutrophil count (ANC) >= 1500/uL
* Platelets >= 100 000/uL
* Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L
* Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
* Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for participant with creatinine levels > 1.5 x institutional ULN
* Creatinine clearance (CrCl) should be calculated per institutional standard
* Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases)
* International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants
* Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
* Women of child-bearing potential (WOCBP) must not be breastfeeding and must have a negative pregnancy test within 3 days prior to initiation of dosing. She must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 120 days after the last dose of study drug. WOCBP must agree to adhere to the contraceptive guidance
* Note: A female participant is eligible to participate if she is not a woman of childbearing potential
* Fertile men must agree to use an acceptable method of birth control while on study drug and up to 120 days after the last dose of study drug and also refrain from donating sperm during this period
* All associated toxicity from previous or concurrent cancer therapy must be resolved (to =< grade 1 or baseline) prior to study treatment administration. Steroids for physiological replacement are allowed
Exclusion Criteria:
* Patients with clinical or radiographic evidence of leptomeningeal disease
* Those who experienced grade 3 or 4 neurotoxicity from prior SRS
* Prior external beam radiation to the brain or whole brain radiation
* Contraindications to MRI (implanted metal device or foreign bodies) or MRI contrast (insufficient renal function or allergy)
* Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled
* Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the principle investigator (PI). Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Subjects with a completely treated prior malignancy and no evidence of disease for >= 2 years are eligible
* Has a known history of or is positive for hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus infection (note treated and cured history of hepatitis C is allowed) (hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
* Note: Without known history, testing needs to be performed to determine eligibility. Hepatitis C antibody (Ab) testing is allowed for screening purposes in countries where HCV RNA is not part of standard of care
* Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
* The use of corticosteroids is not allowed for 10 days prior to initiation of therapy (based upon 5 times the expected half-life of dexamethasone) except patients who are taking steroids for physiological replacement. If alternative corticosteroid therapy has been used, consultation with the PI is required to determine the washout period prior to initiating study treatment
* Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study initiation. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
* Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed) or anticipation of the need for major surgery during the study
* Non-healing wound, ulcer, or bone fracture
* Women who are breast-feeding or pregnant
* Subjects with a history of serious intercurrent chronic or acute illness, such as cardiac or pulmonary disease, hepatic disease, bleeding diathesis or recent major bleeding events or other illness considered by the Investigator as high risk for investigational drug treatment
* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication)
* History of clinically significant cardiac disease or congestive heart failure > New York Heart Association (NYHA) class 2. Subjects must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months
* Investigational drug use within 14 days (or 5 half-lives, whichever is longer) of the first dose of bintrafusp alfa and/or pimasertib
* Has a history of (grade 3 or 4) non-infectious pneumonitis that required steroids or current pneumonitis
* Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of retinal vein occlusion (RVO) or any eye condition that would be considered as risk factor for RVO (e.g. uncontrolled glaucoma or ocular hypertension)
* Creatine phosphokinase level at baseline National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 (> 2.5 x ULN - 5 x ULN) and/or previous history of myositis or rhabdomyolysis
* For NSCLC cohort patients whose tumor exhibit activating EGFR mutation, ALK or ROS translocation and have a standard of care molecular targeted therapy available for these mutations, will be excluded from this study. Patients who progressed or could not tolerate these standard of care molecular targeted agents are eligible for this study. Lung adenocarcinoma patients may be consented prior to the EGFR and ALK status being known, but EGFR and ALK status must be determined prior to initiating therapy
* Administration of live, attenuated vaccine therapies for the prevention of infectious diseases within 4 weeks prior to day 1 of treatment and during therapy
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NCT_ID
NCT04789668
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Study_NameBintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases
| 9,188 |
Study Objectives
To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization \[WHO\] grade 3 and 4).
Conditions: Cancer, Lymphoma, Leukemia
Intervention / Treatment:
DRUG: palifermin, RADIATION: Total Body Irradiation, DRUG: Cyclophosphamide, DRUG: Etoposide, DRUG: Placebo
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
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Inclusion Criteria:
* Written informed consent
* Subjects with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma
* Minimum of 1.5 x 10^6 CD34+ cells/kg cryopreserved and to be transplanted.
Exclusion Criteria:
* Cancer other than those specified in inclusion criteria above (except: adequately treated basal cell carcinoma of the skin)
* Prior bone marrow or peripheral blood stem cell transplantation - Negatively selected (purged) stem cell product - Current active infection or oral mucositis
* Congestive heart failure as defined by New York Heart Association class III or IV.
* History of or current diagnosis of pancreatitis
* Inadequate renal function (serum creatinine greater than 1.5x the upper limit of normal per the institutional guidelines)
* Inadequate liver function (direct bilirubin greater than 1.5x the upper limit of normal, aspartate aminotransferase (AST) greater than 3x upper limit of normal and/or alanine aminotransferase (ALT) greater than 3x upper limit of normal per the institutional guidelines)
* Inadequate pulmonary function as measured by a corrected diffusion capacity of carbon monoxide (DLCO) less than 50% of predicted.
* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
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NCT_ID
NCT00109031
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Study_NamePalifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
| 1,959 |
Study Objectives
This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.
Conditions: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Intervention / Treatment:
DRUG: Nilotinib
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Patients who complete CAMN107A1101 and obtained Informed concent by document
Exclusion Criteria:
* None
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NCT_ID
NCT01279473
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Study_NameStudy to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)
| 1,223 |
Study Objectives
This randomized Phase II trial to establish the efficacy of traditional Chinese medicine (TCM) herbal products above control group for treating fatigue in patients with cancer.
Conditions: Cancer-related Problem/Condition
Intervention / Treatment:
DRUG: RSYRT decoction, DRUG: Astragalus membranaceus
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
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Inclusion Criteria:
Pathological diagnosis of malignant tumors; 3 months without surgery, radiotherapy and chemotherapy, biological treatment; Hemoglobin > 11g/L; Complete remission of the lesion, or recent review of the Disease is stable, the estimated survival time is more than 6 months; ECOG score is 0 <= age <= 2, fatigue score of the last 24 hours > 4 ; Age is 18 <= age <= 65 years; TCM syndrome differentiation for deficiency of qi; Liver, kidney function, electrolyte normal; Willing to join the group and sign the informed consent.
Exclusion Criteria:
Allergies to herbs and plant drugs; Uncontrollable diabetes, hypertension, TSH abnormalities, uncontrollable pain, and a history of myocardial infarction within 6 months; Scores of anxiety disorders and depression (HAD-D) were 11 or more, antidepressants and antioxidants were used in the past month; Breast cancer receptor positive patients took endocrine therapy drugs; Tonics were used in the past 2 weeks.; Children, pregnant and lactating women; Receiving anemia-related treatment; Chinese medicine syndrome differentiation with excessive heat; Unable to read or understand the scale.
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NCT_ID
NCT03911921
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Study_NameRSYR for Fatigue Reduction in Cancer Survivors
| 16,291 |
Study Objectives
This study aim is to compare the effect of magnesium sulphate combined with low dose rocuronium versus standard dose rocuronium
Conditions: Anesthesia
Intervention / Treatment:
DRUG: standard rocuronium dose, DRUG: Magnesium sulfate
Location: Egypt
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
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Inclusion Criteria:
Patients with Laryngeal tumors
ASA I-II
Age 30 <= age <= 70 years
Exclusion Criteria:
Renal and or hepatic insufficiency
Neuromuscular disease
Large glottic and/or supra-glottic lesions with or without breathing difficulties
Known allergy to any of the used drug
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NCT_ID
NCT04510337
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Study_NameDoes Adding Magnesium Sulphate to Low Dose Rocuronium Affects Depth of Blockade
| 15,419 |
Study Objectives
Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of rubitecan in this patient population.
Conditions: Tumors
Intervention / Treatment:
DRUG: Rubitecan
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* The patient is at least 18 years.
* The patient has histologically or cytologically proven malignancy recurrent or refractory to standard treatment or for which there is no standard therapy.
* The patient has measurable disease.
* The patient has sufficiently recovered from the acute toxic effects of previous chemotherapy, radiotherapy (no less than 3 weeks prior to randomization), and/or immunotherapy.
* The patient's estimated life expectancy is at least 8 weeks.
* The patient has a National Cancer Institute Common Toxicity Criteria (NCI CTC) Performance Status between 0 and 2.
* The patient has adequate bone marrow function.
* The patient must not have active central nervous system (CNS) metastases.
Exclusion Criteria:
* The patient has any serious, uncontrolled intercurrent illness or infection.
* The patient is receiving anti-retroviral therapy (HAART) for HIV infection.
* The patient is pregnant or nursing.
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NCT_ID
NCT00113113
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Study_NameStudy of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction
| 7,474 |
Study Objectives
This is a multicenter,open-label trial to evaluate activity and safety of the investigational intensive in HIV+ patients with Burkitt's lymphoma.
Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL was thought to limit the ability to administer intensive chemotherapeutic regimens due to infection rate. However, the advent of highly active antiretroviral therapy (HAART) and evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard chemotherapeutic regimens with improved outcomes have led investigators to treat HIV-positive patients with the same intensive chemotherapy regimens used to treat immuno-competent patients. Data suggest that these current approaches, along with supportive care, may result in improved patient outcomes, similar to those in the immuno-competent patient population.
Conditions: HIV, Burkitt's Lymphoma
Intervention / Treatment:
DRUG: Induction Phase, DRUG: Consolidation Phase (on day +50), DRUG: Intensification phase, DRUG: BEAM conditioning, RADIATION: Consolidation radiotherapy
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Histologic diagnosis of Burkitt's lymphoma (WHO 2008)
* HIV sero-positivity
* Age >=18 and <=60 years
* ECOG-PS <=3
Exclusion Criteria:
* CNS parenchymal involvement
* Absolute neutrophil count <1.000 cells/μL and platelets count <75 × 109/L (Burkitt unrelated)
* Creatinine >1,5N (Burkitt unrelated)
* SGOT and/or SGTP >2,5N (Burkitt unrelated)
* Bilirubin >2N (Burkitt unrelated)
* Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance
* Significant cardiac disease or acute myocardial infarction in the last 12 months
* Severe active infection (except for HBV and/or HCV co-infection)
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NCT_ID
NCT01516593
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Study_NameShort Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma
| 19,948 |
Study Objectives
Chronic neuropathic pain is a common problem for breast cancer survivors. Even with the best medical treatment, some survivors continue to experience disabling pain. It is well-established that an interdisciplinary approach is key to the treatment of some types of chronic pain, but little research has been done on the effectiveness of interdisciplinary treatments for cancer survivors with chronic neuropathic pain. The investigators will evaluate the effectiveness of an interdisciplinary approach combining medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life among breast cancer survivors with chronic neuropathic pain. The investigators will also evaluate the impact of the program on psychological distress, pain cognitions, biomarkers of stress and immune function, cognitive function, as well as brain structure and function.
Conditions: Breast Cancer, Painful Neuropathy, Chronic Pain, Worries; Pain or Disability, Quality of Life
Intervention / Treatment:
BEHAVIORAL: Mindfulness-Based Stress Reduction
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
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Inclusion Criteria:
* Female.
* >= 18 years.
* Completed treatment for breast cancer a minimum of 1 year prior to study enrollment.
* Have been experiencing neuropathic pain following their cancer treatment for a minimum of 6 months.
* Report pain intensity levels >=4 (moderate to severe).
Exclusion Criteria:
* Metastatic disease or current evidence of cancer recurrence
* Pregnancy or breastfeeding
* Unable to complete questionnaires in English or French.
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NCT_ID
NCT02125006
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Study_NameThe Effect of an Inter-Disciplinary Program, Including MBSR, in Breast Cancer Survivors With Chronic Neuropathic Pain
| 12,460 |
Study Objectives
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: 5-FU, DRUG: FOLFOX regimen, DRUG: Placebo, DRUG: bevacizumab [Avastin], DRUG: leucovorin, DRUG: onartuzumab [MetMAb]
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Interventional Model: PARALLEL
Masking: DOUBLE
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Inclusion Criteria:
* Adult patients, >= 18 years
* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Measurable disease by RECIST criteria
* Adequate organ system function, as defined by protocol
Exclusion Criteria:
* Prior systemic or radiation therapy for metastatic colorectal cancer
* Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease
* Previously untreated brain metastases
* History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
* History of hematemesis or hemoptysis <= 1 months prior to study enrollment
* Significant cardiovascular disease or disorder
* History of abdominal fistula or gastrointestinal perforation <= 6 months prior to Day 1
* Positive for hepatitis B, hepatitis C or HIV infection
* Other active cancers or history of treatment for invasive cancer within the last 5 years, except for non-melanoma skin cancer
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NCT_ID
NCT01418222
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Study_NameFOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
| 2,541 |
Study Objectives
The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort, dose finding study to assess the safety and efficacy of eltrombopag in patients with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin. Phase I of the study will examine safety and tolerability of various doses of eltrombopag to identify a dose and schedule of eltrombopag. Phase II will confirm that the chosen dose and schedule of eltrombopag from Phase I can deliver clinically meaningful benefit(s) to thrombocytopenic patients by improving platelet numbers.
Conditions: Thrombocytopaenia
Intervention / Treatment:
DRUG: Eltrombopag olamine, OTHER: Placebo
Location: Israel, Germany, Poland, United States, Czech Republic, Italy, Ireland, Belgium, Canada, Greece, Finland, Hungary, India
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
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Inclusion Criteria:Inclusion Criteria Subjects eligible for enrolment in Phase I and II of the study must meet all of the following criteria:
* Signed written informed consent.
* Age >= 18 years.
* Subjects with confirmed solid tumor and scheduled to receive at least two cycles of either gemcitabine monotherapy OR gemcitabine in combination with carboplatin or cisplatin at the same dosages and schedule in the study. Novel anticancer agents (e.g. bevacizumab, erlotinib) may be allowed if considered a standard treatment by the investigator. Subjects with only ONE current diagnosis of primary solid tumor will be allowed into the study.
* Note: For patients scheduled to receive any novel anticancer agents (e.g. bevacizumab, erlotinib), consultation and approval from the GSK medical monitor should occur before the subject is enrolled into the study.
* Life expectancy of at least 3 months, in the opinion of the investigator.
* ECOG-Zubrod performance status <= 2
* For Phase I: Pre-chemotherapy platelet count <= 300 Gi/L in the screening period before the subject start their first planned cycle of treatment with gemcitabine monotherapy OR gemcitabine in combination with carboplatin or cisplatin in the study.
* For Phase II (Part 1 and 2): Subjects must meet one of the following platelet count entry criteria:
1. Subjects have not started the first cycle in this disease setting and have a platelet count < 150 Gi/L in the screening period as measured within 3 days before Day -5, OR
2. Subjects started chemotherapy for this disease setting and had platelet count < 150 Gi/L on Day 1 in the preceding cycle before entry into the study, OR
3. Platelet count < 100 Gi/L at Day 8 in the preceding cycle before entry into the study, OR
4. Platelet count < 100 Gi/L at Day 15 in the preceding cycle before entry into the study (for subjects receiving Gemcitabine monotherapy) Note: For any of these platelet counts, a repeated platelet count may be allowed only once to ensure that the subject meets the above platelet count criteria and the latest count will be taken for the assessment of eligibility to the study..
* Subjects with previous chemotherapy treatment in a previous disease setting are allowed provided they have recovered from chemotherapy related toxicity except alopecia (and the lab parameters mentioned in Inclusion criteria in #9).
* Adequate organ function during screening period defined by the criteria below (adequate baseline organ function):
* SYSTEM LABORATORY VALUES
* Hematologic
* Platelets, see Inclusion criteria
* ANC (absolute neutrophil count) >=1.5 × 109/L
* Hemoglobin >=9 g/dL
* Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) Within 80 to 120% of the normal range
* Hepatic
* Albumin >=2.5 g/dL
* Serum bilirubin <=1.5 x ULN AST and ALT
* 3 × ULN without liver metastases
* 5 × ULN if documented liver metastases
* Renal
* Serum Creatinine <= 1.2 x ULN
* Subjects with AST, ALT or bilirubin values outside the range(s) in the table due to Gilbert's syndrome or asymptomatic gall stones are not excluded.
* Women of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to randomization and agree to use effective contraception, during the study and for 4 weeks following the last dose of investigational product.
* Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from 2 weeks prior to randomization until 13 weeks after the last dose of study treatment.
* Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
* Lactating females.
* Pre-existing cardiovascular disease (congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), unstable angina, or subjects with a QTc >450 msec (QTc >480 msec for subjects with Bundle Branch Block) at study entry, or myocardial infarction within the preceding 6 months. Subjects with a34 pacemaker or defibrillator are not excluded provided that their cardiac function is within normal ranges.
* Note: For patients with pre-existing NYHA Grade II cardiovascular disease, the investigator should consult with GSK medical monitor before enrolling the subject into the study.
* Patients with known factor V leiden, antiphospholipid antibody syndrome, prothrombin gene mutations, ATIII deficiency, protein C deficiency, protein S deficiency OR recent history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the preceding 6 months.
* Note: for patients with known risk factors for thromboembolism e.g., diabetes, hypercholesterolemia, recent major surgery etc., the investigator should consult with GSK medical monitor before enrolling the patient into the study and all risk factors should be documented in the CRF.
* Prior surgery within two weeks before study randomization or radiotherapy (RT) within four weeks before study randomization. Subjects with prior surgery or RT are not permitted into the study unless they have completely recovered from surgery and/or acute RT toxicity except for alopecia.
* Note: Note: patients with minor surgeries or outpatient procedures (e.g. insertion of central venous catheter) are immediately allowed in the study provided that there were no complications from the procedure or surgery.
* History of prior radiotherapy to more than 20% bone marrow bearing sites.
* History of platelet agglutination abnormality, platelet disorders or dysfunction or bleeding disorder that prevents reliable measurement of platelet counts.
* Subjects with a history of CNS metastases or clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan unless properly treated. Subjects with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to randomization will be excluded.
* Treated brain metastases are defined
* Having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed.
* Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician.
Note: if subject has performed a CT scan immediately prior to the screening period and CT could not be repeated, an MRI should be performed in the screening period to exclude the development of brain metastases and/or the progression of the pre-existing brain metastatic lesion(s).
* Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of investigational product in the study. Concurrent participation in another interventional clinical trial or administration of any investigational drug during the study is also not permitted.
* A known immediate or delayed hypersensitivity reaction or idiosyncrasy that, in the opinion of the Investigator or GSK Medical Monitor is due to drugs chemically related to eltrombopag or excipients (e.g. mannitol).
* Subjects with known Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV). Subjects with Gilbert's Syndrome are permitted into the study.
|
NCT_ID
NCT01147809
|
Study_NameSafety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag
| 17,810 |
Study Objectives
The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease.
This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine.
All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD).
This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people:
* who are Turkish citizens
* who are older than 18 years
* who were found out to have mRCC
* who received sunitinib as the first line treatment after finding out the cause for the disease
This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.
Conditions: Carcinoma, Renal Cell, Clear-cell Metastatic Renal Cell Carcinoma
Intervention / Treatment:
DRUG: Sunitinib
Location: Turkey
Study Design and Phases
Study Type: OBSERVATIONAL
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Inclusion Criteria:
* Being a Turkish citizen.
* Being older than 18 years-old.
* Being clinically diagnosed with mRCC and treated.
* Being treated with Sunitinib in first line
Exclusion Criteria:
* Patients whose treatment was initiated but excluded from follow-up for any reason.
|
NCT_ID
NCT05745142
|
Study_NameA Study to go Back Into Records and Observe How People With Metastatic Renal Cell Carcinoma (mRCC) Who Received a Medicine Called Sunitinib Responded to This Medicine.
| 11,517 |
Study Objectives
The purpose of this research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab instead of by the immune system which then recruit the immune system to help fight cancer cells.
All final eligible subjects will receive an intravenous infusion of CT-011. This study will test two dose levels of the study drug:
Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).
Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).
Each group will be given the study drug through an IV (a needle put into a vein in the arm) on day 1. After day 1, the study drug will be given every other week. Patients may be given a total of up to 27 study drug infusions for about 12 months while they are in the study. Approximately 100 patients will participate in this study.
Conditions: Melanoma, Malignant Melanoma
Intervention / Treatment:
DRUG: CT-011
Location: Israel, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Participants must have a histologically or cytologically documented diagnosis of metastatic melanoma.
* Participants age is >= 18 years.
* Stage IV disease that is clearly progressive since last therapy
* ECOG performance status of 0 or 1.
Exclusion Criteria:
* Patients with uveal melanoma.
* Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (eg: + ANA, +RF, antithyroglobulin antibodies) or mild arthritis requiring no therapy or manageable with NSAIDs.
* Prior use of anti PD-1, anti PD-L1 or PD-L2 therapy.
* More than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments.
* Women of child bearing potential who are pregnant
Note: This is only a partial list of eligibility criteria.
|
NCT_ID
NCT01435369
|
Study_NameSafety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma
| 11,277 |
Study Objectives
This phase I trial studies the side effects and best dose of alisertib and romidepsin in treating patients with B-cell or T-cell lymphomas that have returned after a period of improvement (relapsed) or have not responded to treatment (refractory). Alisertib and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Conditions: MYC Positive, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Burkitt Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent Hodgkin Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Burkitt Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Follicular Lymphoma, Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Refractory Hodgkin Lymphoma, Refractory Mantle Cell Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Intervention / Treatment:
DRUG: Alisertib, OTHER: Laboratory Biomarker Analysis, DRUG: Romidepsin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed Hodgkin lymphoma, Burkitt's lymphoma, double-hit lymphoma, other c-Myc positive B-cell lymphoma, diffuse large-B cell lymphoma including those patients with history of transformed follicular lymphoma, mantle cell lymphoma, or peripheral T-cell lymphoma
* Patients must have at least one 1.5 cm bidimensional measurable lesion
* Relapsed or refractory after at least 1 front-line therapy
* Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
* Life expectancy of greater than 12 weeks
* Absolute neutrophil count >= 1,500/mcL
* Platelets >= 75,000/mcL
* Direct bilirubin =< 1 mg/dL
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
* Creatinine =< 2 x institutional upper limits of normal
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of MLN8237 plus romidepsin administration; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MLN8237 plus romidepsin administration
* Ability to understand and the willingness to sign a written informed consent document
* According to current guidelines, patients must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration; these guidelines may change pending results from an ongoing food effects study
Exclusion Criteria:
* Patients who have had chemotherapy, radiation therapy, or other investigational agents within 3 weeks prior to entering study, 6 weeks for nitrosoureas or mitomycin
* Patients with known brain metastases should be excluded from this clinical trial
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237, including but not limited to established allergic reaction to benzodiazepines, or romidepsin; agents that alter gastric pH may change MLN8237 absorption are not permitted; proton pump inhibitors need to be stopped 4 days prior to the first dose of MLN8237; histamine-2 (H2) receptor antagonists are not permitted from the day prior (day -1) through to the end of MLN8237 dosing; antacid preparations are not permitted for 2 hours before or 2 hours after administration of MLN8237
* Co-administration of enzyme-inducing antiepileptic drugs, rifampin, rifabutin, rifapentine, or St. John's wort is not permitted; concurrent bisphosphonate therapy is allowed if it was started before study entry and is maintained at recommended dosing intervals; bisphosphonate therapy may not be initiated after study entry
* Any serious active disease or co-morbid condition, which in the opinion of the principal investigator, will interfere with the safety or compliance of the trial
* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MLN8237 and/or romidepsin
* Ejection fraction (EF) < 40% or myocardial infarction (MI) within the past 3 months; known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen; or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237
* Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed
* Inability to swallow oral medication or to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption, or resection of pancreas or upper bowel; treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, oxcarbazepine, primidone or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study; patients must be cautiously co-medicated with agents that cause corrected QT interval (QTc) prolongation and agents that are strong or moderate enzyme inhibitors during the study
|
NCT_ID
NCT01897012
|
Study_NameAlisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas
| 13,610 |
Study Objectives
The purpose of this study is to determine whether weekly SMS reminders are effective in improving medication adherence of adjuvant aromatase inhibitors in women with breast cancer.
Conditions: Breast Cancer, Medication Adherence
Intervention / Treatment:
OTHER: SMS reminder
Location: Singapore
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Women who have been receiving adjuvant endocrine therapy for at least 1 year, and are continuing to receive adjuvant AI therapy for at least 1 more year.
* Have cellular phone that can receive text messages.
* Singaporean or permanent resident who is currently residing in Singapore.
* Able to give informed consent.
Exclusion Criteria:
* Unable or not willing to comply with study procedures.
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NCT_ID
NCT02524548
|
Study_NameSMS Reminders to Improve Medication Adherence of Aromatase Inhibitors
| 930 |
Study Objectives
The purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) in prostate cancer participants in daily medical practice.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Leuprorelin acetate
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria: Prostate cancer participants who meet all the following criteria:
* Participants for whom prostate cancer was initially diagnosed on or after January 1, 2005
* Participants with no prior history of treatment with Leuplin SR 11.25 mg Injection Kit (as an exception, participants with prior history of treatment with Leuplin 3.75 mg Injection Kit may be enrolled in the survey )
* Participants with prostate-specific antigen (PSA) level determined at baseline or within 3 months prior to the start of treatment with Leuplin SR 11.25 mg Injection Kit
Exclusion Criteria:
*
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NCT_ID
NCT02167893
|
Study_NameLeuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
| 20,742 |
Study Objectives
The purpose of this study is to determine the Maximum Tolerated Dose, Dose Limiting Toxicities and optimal dosing schedule of 4SC-202 investigating its safety, tolerability and pharmacokinetics.
Conditions: Advanced Hematologic Malignancies
Intervention / Treatment:
DRUG: 4SC-202
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Male or female patients, age >= 18 years.
* Patients with Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM),Myelodysplastic Syndrome (MDS) or malignant lymphoma which are relapsed and/or refractory to standard therapy or for which no standard therapy exists. Patients who are not eligible for curative stem cell transplantation or patients who have refused or are not eligible for frontline (chemo-) therapy may also be included.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
* Patients must have a live expectancy of 12 weeks or more.
* Patients must have adequate bone marrow reserve as well as adequate renal and hepatic function and serum electrolytes within a clinically acceptable range.
* Patients must have recovered from any treatment-related toxicities (to Grade 0 or 1 according to Common Terminology Criteria for Adverse Events (CTCAE); except for alopecia, fatigue and Grade 1 neurotoxicity) prior to registration.
Exclusion Criteria:
* Patients who have received previous treatment with an HDAC inhibitor.
* Patients with any gastrointestinal disorder that could interfere with the absorption of 4SC-202
* Patients who are unable to take oral medication.
* Patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate specific antigen (PSA) value of < 0.1 ng/ml; or cervical intraepithelial neoplasia.
* Patients with a history of, who were treated for, or who are suspected of having, hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Patients suspected of having any of these conditions should undergo appropriate evaluations prior to being enrolled in the study.
* Patients with precedent anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last two weeks or a longer period depending on the known PK characteristics of the agents used.
* Patients with history or current evidence of clinically relevant allergies or idiosyncrasy to drugs (especially of similar chemical composition to the study drug) or food.
* Patients with symptomatic brain metastases/central nervous system (CNS) involvement.
* Patients with significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure (New York Heart Association (NYHA) Class III or IV) related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
* Patients with a marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval > 450 msec (Grade 1 CTCAE); Long-QT-Syndrome; the required use of concomitant medication on 4SC-202 dosing days that may cause Torsade de Pointes.
* Therapy with agents known to prolong the QT interval, such as certain antibiotics (i.e. erythromycin, clarithromycin), antidepressants (i.e. doxepin, amitryptilin) or neuroleptics (i.e. haloperidol, clozapin).
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NCT_ID
NCT01344707
|
Study_NameOral Histone Deacetylase Inhibitor 4SC-202 in Patients With Advanced Hematologic Malignancies (TOPAS)
| 17,705 |
Study Objectives
This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.
Conditions: Neoplasms, Breast
Intervention / Treatment:
DRUG: Trastuzumab, DRUG: Paclitaxel, DRUG: FEC75, DRUG: Lapatinib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Have signed an informed consent form (ICF) and a Patient Authorization Form (HIPAA).
* Have histologically or cytologically confirmed ErbB2- (HER2/neu-) overexpressing invasive breast cancer (T2 <= age <= 4, N0 <= age <= 2).
* ErbB2 overexpressing breast cancer, defined as one of the following definitions:
* 3+ staining by immunohistochemistry (IHC),
* a fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus
* a FISH ratio of more than 2.2.
* Have either measurable or evaluable disease.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 <= age <= 1 (Refer to Section 11.4).
* Have LVEF within the institutional range of normal as measured by either echocardiogram (ECHO) or MUGA scans. The same modality must be used consistently throughout the study.
* Be deemed able to tolerate 8 cycles of preoperative chemotherapy, including 4 cycles with an anthracycline (epirubicin).
* Must be willing to undergo 2 mandatory core biopsies (4 passes each) after diagnosis to obtain tissue for biologic expression profiling. Any subject with clinically palpable residual disease may undergo an optional third biopsy to allow identification of presumed pathways of resistance to therapy. This information might be useful in providing the subject with options for other targeted therapies if definitive surgery confirms residual disease. Definitive local therapy with surgery and radiation therapy as indicated will be performed after completion of 12 weeks of paclitaxel-based chemotherapy.
* Are able to swallow and retain oral medication (intact pill).
* Are able to complete all screening assessments as outlined in the protocol.
* Have adequate organ function as defined in Table 4:
Table 1 Baseline Laboratory Values
Hematologic:
ANC (absolute neutrophil count) >1.5 x 109/L hemoglobin >9 g/dL platelets >75 x 109/L
Hepatic:
albumin >2.5 g/dL serum bilirubin <1.25 x ULN AST / ALT <3 x ULN if no documented liver metastases AST / ALT <3 x ULN with documented liver metastases
Renal:
serum creatinine <2.0 mg/dL
* OR - calculated creatinine clearance >40 mL/min
* Are subjects aged >18 years with any menopausal status:
Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal)
Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility.) This category includes women with oligomenorrhea (severe), women who are perimenopausal, and young women who have begun to menstruate. These subjects must have a negative serum pregnancy test at screening and agree to one of the following:
Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or Consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progestogen only) where not contraindicated for this subject population or per local practice.; or barrier methods, including diaphragm or condom with a spermicide.
Please note that breast cancer subjects on this trial cannot receive injectable levonorgestrel or injectable progestogen due to the potential for an adverse effect of anti-hormonal therapies on chemotherapy administered for breast cancer [Albain, 2002]. Progestogen may also affect the proliferative rate of endocrine-responsive tumors.
Exclusion Criteria:
* Have received any prior chemotherapy.
* Had prior therapy with an ErbB1 and/or ErbB2 inhibitor.
* Are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication.
* Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded.
* Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety.
* Have an active or uncontrolled infection.
* Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
* Have active cardiac disease, defined as one or more of the following:
History of uncontrolled or symptomatic angina History of arrhythmias requiring medications, or clinically significant Myocardial infarction <6 months from study entry Uncontrolled or symptomatic congestive heart failure Ejection fraction below the institutional normal limit Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
* Are pregnant or breastfeeding.
* Have received concurrent treatment with an investigational agent or participate in another clinical trial.
* Have received concurrent treatment with prohibited medications (refer to Section 5.8.2 for details on prohibited medications).
* Have used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.
* Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the agents used in this study or their excipients.
* Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin).
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NCT_ID
NCT00524303
|
Study_NameLapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.
| 17,292 |
Study Objectives
The development of biomarkers will lead the dynamic of personalized medicine and fill the unsatisfied needs in oncology for prediction of therapeutic response.
Molecular imaging enables non invasive quantification of biomarkers. The development of molecular imaging biomarkers is closely related to the development of therapeutic molecules. Among the potential targets, kinases offer a lot of advantages: (i) they play a central role in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic (imatinib, sorafenib, sunitinib...) with application across a variety of therapeutic indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the most sensitive and dedicated to evaluate small molecules. However few radiotracers are available and their specificity limits their clinical use. The IMAkinib® approach is an innovative method proposed to develop new PET radiotracers adapted to current medical and economical challenges.
The epidermal growth factor receptor (EGFR) is an established target for the treatment of advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs) Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19). Unfortunately the majority of patients will develop a resistance to the TKI in the long term (6-12 months). If the mechanism of resistance is not yet fully characterized, most patients (50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated (\[18F\]-ODS2004436) which was further evaluated in a preclinical imaging study to determine the feasibility of TKI-PET. The investigators proved in vivo that \[18F\]-ODS2004436 a compound is a good candidate to evaluate the EGFR activity in human lung tumours using PET imaging.
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
OTHER: Injection of [18F]-ODS2004436 radiotracer
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* more than 18 years,
* Willing and able to sign written informed consent,
* Histologically confirmed diagnosis of adenocarcinoma NSCLC:
1. positive mutated KRas homogeneous population for EGFR Wild type (WT) patients (exclusive with EGFR mutation)
2. EGFR activating mutation (All mutations: 719, 790, 861, 858 or del exon 19 and exon 20),
* Patient with EGFR mutation will be sensitive to TKI
* Treatment naïve patients,
* Performance status <= 2 on the Eastern Cooperative Oncology Group (ECOG) criteria,
* No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole,
* Adequate hematologic (ANC count >= 1,500/uL, platelet count >= 100,000/mm3), hepatic (bilirubin level <= 1.5 mg/dL, Transaminase (AST/ALT) <= 80 IU/L), and renal (creatinine concentration <= 1.5 mg/dL) function,
* Patients with brain metastasis are allowed unless there were clinically significant neurological symptoms or signs.
Exclusion Criteria:
* Known severe hypersensitivity to Gefitinib or Afatinib or any of the tablet excipients,
* Inability to swallow tablets,
* Other coexisting malignant disease,
* Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's wort; severe or uncontrolled systemic disease; clinically active interstitial lung disease (except uncomplicated lymphangitic carcinomatosis),
* Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control,
* Subjects under guardianship, curators or judicial protection
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NCT_ID
NCT02847377
|
Study_NameA Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
| 21,219 |
Study Objectives
This phase I trial will determine safety, dose-limiting toxicities (DLT) and maximum tolerable dose (MTD) of the protease inhibitor, Nelfinavir (NFV), when given with chemoradiotherapy as post-operative therapy for glioblastoma multiforme (GBM). Oral NFV is a standard therapy for patients with HIV and the safety of 1250 mg BID NFV is well-established. Case studies have also reported that HIV patients have received radiotherapy for cancer, while on 1250 mg BID NFV. This is the first trial of oral NFV and chemoradiotherapy for GBM patients. Although unacceptable toxicity is unlikely, two NFV dose levels (625, and 1250 mg BID) will be evaluated in a cohort escalation design of 3-6 subjects. At the MTD, 19 additional subjects will be enrolled to generate pilot data on radiographic response and to evaluate further toxicity. A maximum of 31 subjects will be enrolled on the trial.
Conditions: Glioma
Intervention / Treatment:
DRUG: Nelfinavir
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients > 18 years.
* Newly diagnosed and histologically confirmed supratentorial WHO Grade IV astrocytoma status-post maximally achievable resection.
* ECOG performance status 0 <= age <= 2.
* Absolute Neutrophil Count >= 1500 per mm3
* Platelet count >= 100,000 per mm3
* Serum creatinine < 1.5 times the upper limit of normal
* Serum AST or ALT < 2 times the upper limit of normal
* Serum bilirubin < 1.5 mg/dl
* Patients who were receiving corticosteroids have to receive a stable or decreasing dose for at least 14 days before randomization.
* No prior cranial radiotherapy will be permitted.
* No known HIV infection.
* The effects of NFV on the developing human fetus have been studied in HIV positive women.
We do not, however, know the risks along with radiation. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Patients must sign an informed consent document that indicates they are aware of the investigative nature of the treatment in this protocol as well as the potential risks and benefits.
Exclusion Criteria:
* Prior cranial radiotherapy.
* Patients may not be receiving or have received any other investigational agents during/or within 1 month prior to treatment with NFV.
* Pregnant or lactating women.
* Patients receiving the following drugs that are contraindicated with NFV will be excluded: antiarrhythmics (amiodarone, quinidine), antimycobacterial (rifampin), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), herbal products (St. John's wort), HMG-CoA reductase inhibitors (lovastatin, simvastatin), neuroleptic (pimozide), proton pump inhibitors, sedatives/hypnotics (midazolam, triazolam).
* Patients receiving the following drugs will be clinically evaluated as to whether dosage/medication can be changed to permit patient on study: anti-convulsants (carbamazepine, phenobarbital, phenytoin), anti-mycobacterial (rifabutin), PDE5 inhibitors (sildenafil, vardenafil, tadalafil), HMG-CoA reductase inhibitor (atorvastatin, rosuvastatin), immunosuppressants (cyclosporine, tacrolimus, sirolimus), narcotic analgesic (methadone), oral contraceptive (ethinyl estradiol), macrolide antibiotic (azithromycin), antidepressant (trazadone).
|
NCT_ID
NCT01020292
|
Study_NameA Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
| 5,023 |
Study Objectives
Methadone is a synthetic mu opioid agonist that has been proved as clinically effective in pain management. However, methadone usage for pain control in Thailand has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. Therefore, this prospective study was conducted to evaluate the efficacy and safety of a methadone protocol in Thai patients with severe chronic noncancer and cancer pain.
Conditions: Pain, Chronic
Intervention / Treatment:
DRUG: Methadone
Location: Thailand
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Outpatients aged 18 or over who suffered from severe chronic cancer or noncancer pain to be firstly treated with methadone as analgesics
Exclusion Criteria:
* QTc interval that was more than 500 msec
* History of opioid addiction
* Having structural heart diseases
* During pregnancy or lactation period
* Patients who have hypersensitivity to methadone
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NCT_ID
NCT02335398
|
Study_NameDevelopment and Evaluation of a Methadone Protocol for Severe Chronic Pain Management
| 22,386 |
Study Objectives
Randomized trial to determine if neo-adjuvant subcutaneous GM-CSF restores the host regional lymph node immunity
Conditions: Melanoma
Intervention / Treatment:
DRUG: GM-CSF, OTHER: Standard of Care
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria
To be eligible for the study, patients must satisfy the following criteria:
* Histologically confirmed primary cutaneous malignant melanoma
* 1 <= age <= 4mm Breslow depth
* Scheduled for sentinel lymph node biopsy as part of their standard surgical management
* Man or woman, age >= 18 years
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 2 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Sexually active WOCBP must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. All WOCBP must have a negative pregnancy test prior to first receiving GM-CSF.
* Men must agree to use and utilize an adequate method of contraception throughout treatment and for at least 2 weeks after study drug is stopped
* All patients must be willing and able to give written informed consent.
Exclusion Criteria Subjects meeting any of the following criteria are ineligible for study entry
* Clinical stage III or IV disease
* Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of immunologic disease (e.g. rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis, motor neuropathy considered of autoimmune origin)
* Any underlying medical conditions which, in the opinion of the investigator, will make the administration of GM-CSF hazardous or obscure the interpretation of adverse events; such as, psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and followup schedule
* Any vaccination therapy within 4 weeks prior to GM-CSF administration
* Concomitant therapy with any of the following within the past 3 months: GM-CSF, interferon, other non-study immunotherapy regimes; cytotoxic chemotherapy
* Immunosuppressive mediations (steroids, tumor necrosis factor (TNF)-inhibitors, azathioprine, etc.) within the past 6 weeks
* Active or chronic infection with HIV, hepatitis B or hepatitis C
* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and 2 weeks after cessation of the study drug.
* Prisoners or subjects who are compulsorily detained
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NCT_ID
NCT02451488
|
Study_NameNeoadjuvant Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Cutaneous Stage L-lll Melanoma
| 18,217 |
Study Objectives
This study is for patients with prostate cancer that is metastatic, progressive, and resistant to hormonal manipulation and mitoxantrone chemotherapy.Patients have previously been treated with surgical removal of the testes or hormone therapy, and subsequently with chemotherapy that included the drug, mitoxantrone (Novantrone). Patients will have prostate cancer that has worsened despite these treatments.
We hope to learn whether the combination chemotherapy decreases cancer symptoms and tests, and to determine how frequently serious side effects occur with acceptable toxicity from the chemotherapy.
Conditions: Prostate Adenocarcinoma
Intervention / Treatment:
DRUG: Estramustine, DRUG: Docetaxel, DRUG: Carboplatin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patient must have had a histological diagnosis of adenocarcinoma of prostate and currently must have metastatic disease (stage TxNxM1) that is unresponsive or refractory to hormone therapy and mitoxantrone-based chemotherapeutic regimens. Patients must have metastatic prostate cancer deemed to be hormone- and mitoxantrone refractory by one or more of the following (despite androgen ablation, anti-androgen withdrawal and mitoxantrone therapy where applicable):
1. Progression of measurable disease assessed within 28 days prior to registration.
2. Progression of non-measurable (i.e. bone scan or PET scan) disease assessed within 42 days prior to registration.
3. Rising PSA - defined as at least 2 consecutive rises in PSA documented over a reference value (measure 1). The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater then the second measure and it must be obtained at least 7 days after the 2nd measure. Patient must have a PSA concentration of at least 10 ng/ml in addition to increasing PSA to be eligible based on PSA criteria alone. No minimum PSA is required for patients with measurable disease or non-PSA evaluable disease.
* Age > 18 years
* Must have pre-study PSA (within 28 days prior to registration) Note: The PSA result (done within 28 days prior to registration) need not be elevated for inclusion provided other criteria for progression are met.
* Must have received prior hormonal therapy and have a castrate level of testosterone. Patients treated with orchiectomy are eligible. If they have been treated with non-steroidal anti-androgens, the patients must have ceased taking flutamide or nilutamide at least 28 days prior to enrollment and at least 42 days prior to enrollment for bicalutamide, and patients must have demonstrated disease progression. Either method of castration can have been supplemented with nonsteroidal antiandrogen (e.g. flutamide, bicalutamide, nilutamide).
* Must have received prior mitoxantrone therapy
* Prior radiation therapy is allowed but it must have been to less than 25% of total body bone marrow (see Appendix 5). This includes prior use of samarium, but patients cannot have received strontium. (>28 days must have elapsed since completion of RT with recovery from side effects. Soft tissue disease irradiated in the prior 2 months is not and may not be designated as measurable disease).
* May have received prior surgery (21 days must have elapsed since completion of surgery with recovery from side effects)
* Creatinine less than or equal to 1.5x the institutional upper limit of normal (within 28 days prior to registration)
* Bilirubin less than or equal to the institutional upper limit of normal (within 28 days prior to registration).
* Liver enzymes: If alkaline phosphatase is less than or equal to 4 x institutional upper limit of normal (ULN), then AST and ALT must be less than or equal to 2.0 x ULN. If alkaline phosphatase is > 4 x ULN in patients with bone metastases, then AST and ALT must be < 1.25 x ULN.
* Adequate bone marrow function. Complete blood count with differential must be done within 14 days prior to registration
1. WBC greater than or equal to 3000 cells/mm3
2. Absolute neutrophil count greater than or equal to 1500 cells/mm3
3. Platelet count greater than than or equal to 100,000 cells/mm3
4. Hemoglobin greater than or equal to 9.0 g/dl
* ECOG performance status 0 <= age <= 3. (For patients with PS of 3, cause must be due to pain secondary to bone metastases to be eligible)
* Must have pain (or be controlled on treatment for pain) attributable to metastatic prostate cancer as defined by a PPI score greater than or equal to 1. Subjects must have stabilization of their analgesic medications for at least one week prior to receiving study medication.
* No other chemotherapy, biological response modifiers, RT, radioisotope therapy (e.g. samarium or strontium), corticosteroid (>10mg of prednisone per day or equivalent), bisphosphonates or concomitant hormonal therapy may be given during protocol treatment. Patients may be treated with bisphosphonates provided they are initiated prior to study entry.
* Completed baseline QOL measures prior to registration (EORTC QLQ-C30 plus prostate cancer module; McGill Pain Questionnaire; Pain Medication Log. The nurse or CRA must complete QOL Cover sheet for baseline assessment prior to registration. Patient must be willing to complete other questionnaires while on study. If unable to complete questionnaires in English or Spanish, patient can be registered without contributing to QOL study).
* Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period (90 days) thereafter.
* Patients must be available for treatment and follow-up of any objective responses and/or residual toxicities.
* Willing and able to give informed consent and have signed an IRB approved informed consent
Exclusion Criteria:
* Myocardial infarction or angina pectoris within one year of registration
* History of brain metastases or currently has treated or untreated brain metastasis. (Patients with neurological symptoms must have CT or MRI brain negative for metastatic disease within 56 days prior to registration)
* Active thrombophlebitis or hypercoagulability.
* Known history of pulmonary embolism or deep venous thrombosis.
* Not recovered from major infections and/or surgical procedures, or has significant active concurrent other medical illness precluding protocol therapy or survival.
* Known or anticipated severe hypersensitivity reaction to estramustine, docetaxel, polysorbate 80 or carboplatin
* Other prior malignancy (except patients who have had another stage I or II malignancy currently in complete remission or other cancer with no evidence of disease for greater than 5 years from accrual to the current trial. Patients with basal or squamous cell carcinoma of the skin that have been treated with curative intent can be accrued to this trial 30 days after treatment).
* Preexistent peripheral neuropathy greater than or equal to grade 2
* Prior therapy with estramustine, taxanes (e.g. paclitaxel, docetaxel) or platinum-based (e.g. cisplatin, carboplatin, oxaliplatin) drugs or ongoing therapy
* Ongoing therapy with drugs known to inhibit P4503A4 drug metabolism including: Macrolide antibiotics: erythromycin, troleandomycin, azithromycin; Calcium antagonists: nifedipine, diltiazem; Imidazole antifungal agents: ketoconazole, itraconazole, fluconazole; HIV protease inhibitors; Immunosuppressive agents: cyclosporin, FK-506
* Ongoing therapy with drugs known to induce P4503A4 drug metabolism including: Phenobarbital, phenytoin, carbamazepine, griseofuvin and rifampin.
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NCT_ID
NCT00183924
|
Study_NameEstramustine, Docetaxel, and Carboplatin for Patients With Hormone Refractory Prostate Cancer Progressing After Mitoxantrone-Based Chemotherapy.
| 6,515 |
Study Objectives
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: AMG 386, DRUG: AMG 386, DRUG: AMG 386 Placebo, DRUG: Pemetrexed, DRUG: Carboplatin
Location: United States, Spain, Australia, Belgium, Canada, Greece
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
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Inclusion Criteria:
* Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
* Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
* Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL >= 45 mL/min
* Other criteria may apply
Exclusion Criteria:
* Any prior chemotherapy or targeted therapy for non-squamous NSCLC
* Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
* Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
* Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
* History or presence of central nervous system metastases
* Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization
* History of pulmonary hemorrhage or gross hemoptysis within 6 months
* History of arterial or venous thromboembolism within 12 months
* History of clinically significant bleeding within 6 months
* Clinically significant cardiovascular disease within 12 months
* Other criteria may apply
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NCT_ID
NCT01666977
|
Study_NamePhase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
| 22,003 |
Study Objectives
The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.
Conditions: Adult Acute Lymphocytic Leukemia
Intervention / Treatment:
DRUG: Cyclophosphamide, DRUG: Dexamethasone / Prednisolone, DRUG: Cytarabine, DRUG: Idarubicin, DRUG: Granulocyte-Colony-Stimulating Factor, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Rituximab, DRUG: HDARAC, DRUG: Vincristine, DRUG: Depocyte, DRUG: Asparaginase
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Diagnosis of acute lymphoblastic leukemia (pro B, pre B, c-ALL or T-ALL), proved by morphology and immunophenotyping
* Age > 55 yrs (no upper age limit)
* Written informed consent
Exclusion Criteria:
* Severe leukemia associated complications, not controllable before therapy onset e.g.
* life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding)
* Severe comorbidity e.g.
* decompensated renal failure if not caused by leukemia with Creatinine > 2x ULN
* heart failure (NYHA II/IV), instable Angina, significant coronary stenosis
* hepatic insufficiency e.g. liver cirrhosis or chronic active hepatitis with bilirubin > 1,5 x ULN and/or ASA, ALA, AP > 2,5 ULN
* decompensated metabolic disturbances (e.g. not controllable diabetes)
* severe obstructive or restrictive pulmonary disease with hypoxaemia
* Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
* Active second neoplasia
* HIV infection
* Severely reduced general condition
* Cytostatic pre-treatment of ALL
* Chemotherapy treatment of any other malignancy during the last 5 years
* Participation in other clinical trials interfering with the study therapy
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NCT_ID
NCT00198978
|
Study_NameGerman Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
| 18,051 |
Study Objectives
In vitro statins, inhibitors of the HMG-CoA-reductase, have been shown to overcome cell adhesion mediated drug resistance at very low concentrations. The purpose of the study is to investigate the in vivo efficacy of simvastatin as inhibitor of cell adhesion mediated drug resistance. Patients refractory to ongoing chemotherapy will receive concomitantly simvastatin and response will be monitored by paraprotein levels
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Simvastatin
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* proven multiple myeloma,
* refractory to ongoing chemotherapy (bortezomib,
* bendamustin dexamethasone),
* measurable paraprotein,
* serum protein below 11 g/dl,
* age > 18 years,
* life expectancy greater 6 months,
* contraception in women,
* expected compliance,
* written consent
Exclusion Criteria:
* severe heart failure,
* not controlled hypertension or diabetes,
* risk factors for rhabdomyolysis,
* creatinin kinase below 30ml/min,
* active liver disease,
* myopathy,
* allergy to simvastatin,
* pregnancy,
* acute infectious disease
|
NCT_ID
NCT00399867
|
Study_NameSimvastatin as Inhibitor of Cell Adhesion Mediated Drug Resistance in Patients With Refractory Multiple Myeloma.
| 9,634 |
Study Objectives
This is a phase I, open-label, multiple dose, dose escalation study to assess the safety, tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally in patients with advanced cancer and lymphomas.
Conditions: Neoplasms
Intervention / Treatment:
DRUG: Aneustat (OMN54)
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histological or cytological evidence of malignancy
* Male or female, >= 18 years
* Presence of advanced tumours, i.e., measurable or non-measurable disease (RECIST criteria, version 1.1)that have recurred or progressed following standard therapy
* Able to swallow the oral capsule form of the drug
* Failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
* Haematology within 7 days of Day 1 (initial dose):
* Hemoglobin (Hb) > 9.0 g/dL
* Platelets >= 100,000 cells/mm3 (or, >=100 x 10/L)
* Absolute neutrophil count (ANC) > 1.5 cells x109/L (or, > 1500 cells/mm3)
* Chemistry within 7 days of Day 1 (initial dose):
* AST(SGOT)/ALT(SGPT) <= 2.5 x ULN if no liver metastases, AST(SGOT)/ALT(SGPT) < 5 x ULN if liver metastases
* Bilirubin < 1.5 x ULN unless Gilbert's Syndrome
* Serum creatinine <= 1.25 ULN
* Coagulation within 7 days of Day 1 (initial dose):
*INR <= 1.5
* ECOG Performance Status between 0 - 2 and estimated life expectancy of > 3 months.
* Having the initiative and means to be compliant with the protocol (as judged by the Principal Investigator) and is within a feasible geographical proximity of the study center to make the required study visits.
* Written informed consent obtained prior to any study screening procedures
* Females of childbearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus) must have a negative urine pregnancy test (UPT) within 7 days of Day 1 (initial dose)
* Females of childbearing potential must agree to use an effective method of contraception (i.e., sexual abstinence, condoms, intrauterine device, diaphragm) from Screening period and throughout study participation.
Exclusion Criteria:
* Patient has uncontrolled or symptomatic brain metastases (If a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to Day 1 dosing).
* Use of an investigational medication or device within 30 days of initiating study therapy (Day 1).
* Major surgery within 30 days prior to first dose (Day 1).
* Radiotherapy, chemotherapy, or immunotherapy within 28 days prior to Day 1 (not including palliative radiotherapy at focal sites).
* Pregnancy or lactation.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY Heart Association Class III or IV, see Appendix 3), unstable angina pectoris, unstable cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
* Screening (within approximately 28 days of registration) 12-lead electrocardiogram (ECG) that is abnormal and clinically significant
* Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption.
* Use of warfarin, i.e., Coumadin®, Jantoven® within 7 days prior to Day 1 (initial dosing)
* Intolerance or aversion to porcine ingredients that are used for the OMN54 oral capsules in the investigational medicine, OMN54 (Aneustat™).
* Known hypersensitivity to any of the three botanical constituents of Aneustat™ (OMN54), or other similar plants; or to plants belonging to Labiatae or Lamiaceae families, soy, or Aneustat™ (OMN54) excipients
* Use of Sophora subprostrata root (SSR) or herba serissae within 14 days prior to Day 1.
|
NCT_ID
NCT01555242
|
Study_NameA Study of Aneustat (OMN54) in Patients With Advanced Cancer and Lymphomas
| 12,090 |
Study Objectives
This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.
Conditions: Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage IV Non-Small Cell Lung Cancer AJCC v7
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, OTHER: Placebo, OTHER: Quality-of-Life Assessment, DRUG: Sunitinib Malate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion Criteria:
* Histologic or cytologic documentation of primary non-small cell lung cancer
* Stage IIIB or IV disease patients who are not candidates for combined modality therapy (chemoradiotherapy)
* No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis; patients with central nervous system (CNS) metastases must be asymptomatic, must have received definitive therapy (>= 6 weeks since resection or >= 2 weeks since radiotherapy) for brain metastases, and be off steroids or on a stable dose for 2 weeks prior to registration
* No cavitary lesions
* Patients must have received one chemotherapy regimen for stage IIIB or IV NSCLC; the regimen must include four cycles of platinum-based doublet chemotherapy with or without bevacizumab (bevacizumab may not be given beyond the fourth cycle of chemotherapy); patients must have achieved a complete response, partial response, or stable disease to first-line chemotherapy and have no evidence of disease progression; patients will be registered 3 <= age <= 5 weeks following day 1 of cycle 4 of prior therapy
* No prior adjuvant chemotherapy for stage I-III resected NSCLC or combined modality therapy for stage III NSCLC
* No other primary therapy (including experimental therapy) for NSCLC; palliative radiation therapy must have been completed at least one week before planned start of protocol therapy
* Patients must have measurable or non-measurable disease
* Measurable disease: lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan
* Non-measurable disease: all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Non-pregnant and non-nursing
* No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT (QTc) interval >= 500 msec (within 2 years prior to registration); the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy
* Patients with class I New York Heart Association (NYHA) heart failure are eligible; patients with a history of class II NYHA heart failure are eligible, provided they meet at least one of the following criteria:
* Patients with a history of class II heart failure who are asymptomatic on treatment
* Patients with prior anthracycline exposure
* Patients who have received central thoracic radiation that included the heart in the radiotherapy port
* Patients with a history of class III or IV NYHA heart failure within 12 months prior to registration are not eligible
* No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident or transient ischemic attack within the last year
* Patients with hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical therapy) are not eligible
* Patients who require use of therapeutic anticoagulation for thromboembolic disease are not eligible; Note: low doses of coumadin (up to 2 mg daily) are permitted for prophylaxis of thrombosis
* No history of venous thrombosis, pulmonary embolism, or hypercoagulopathy syndrome
* No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis; patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 ml of blood per episode and less than 10 ml of blood per 24-hour period in the best estimate of the investigator
* Patients with a history of hypothyroidism are eligible, provided they are currently euthyroid
* None of the following within 28 days of beginning treatment: abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound, ulcer, or bone fracture
* The following inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited within 7 days before beginning and during treatment with sunitinib: azole antifungals (ketoconazole, itraconazole), diltiazem, clarithromycin, erythromycin, verapamil, delavirdine, and human immunodeficiency virus [HIV] protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir); the following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib: rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John?s Wort, efavirenz, tipranavir; other inhibitors and inducers of CYP3A4 may be used if necessary, but their use is discouraged
* Patients unable to take oral medication are not eligible
* Granulocytes >= 1,500/mcl
* Platelet count >= 100,000/mcl
* Total bilirubin =< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=< 2.5 x ULN; patients with liver metastases may have AST and ALT =< 5 x ULN; all other patients will have AST and ALT =< 2.5 x ULN
* Creatinine =< 1.5 mg/dl
|
NCT_ID
NCT00693992
|
Study_NameSunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy
| 5,459 |
Study Objectives
The purpose of this study is to evaluate the effect of food on the single-dose pharmacokinetics (PK) of alisertib administered as an enteric-coated tablet (ECT) formulation in participants with advanced solid tumors or lymphomas.
Conditions: Advanced Solid Tumors, Lymphoma
Intervention / Treatment:
DRUG: Alisertib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
|
Inclusion Criteria:
* >= 18 years
* Histologically or cytologically confirmed advanced tumors or lymphomas for which standard curative or life-prolonging treatment does not exist, or is no longer effective or tolerable
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Participant must meet protocol-specified laboratory values
* Suitable venous access
* Female participants who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time or agree to practice true abstinence
* Male participants who agree to practice effective barrier contraception during the entire study and through 4 months after the last dose of study drug OR agree to practice true abstinence
Exclusion Criteria:
* Prior or current investigational therapies within 4 weeks before the first dose of alisertib
* Female participants who are lactating or pregnant
* Participant requiring treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days before the first dose of alisertib and during the study
* Medical conditions requiring daily, chronic, or regular use of proton pump inhibitors (PPIs) within 7 days preceding the first dose of alisertib, or histamine (H2)-receptor antagonists
* Participant requiring systemic anticoagulation
* Ongoing nausea or vomiting that is Grade 2 or worse in intensity
* Known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption, excretion, or tolerance of alisertib
* History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease
* Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
* Participant who are lactose-intolerant or are unwilling/unable to consume the protocol specified standardized high-fat breakfast
Other protocol-defined inclusion/exclusion criteria may apply
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NCT_ID
NCT01898078
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Study_NameFood Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas
| 18,002 |
Study Objectives
RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by lenalidomide and azacitidine. Giving autologous lymphocytes after the transplant may help destroy any remaining cancer cells.
PURPOSE: This pilot trial is studying how well giving lenalidomide together with azacitidine works when followed by autologous stem cell transplant and autologous lymphocyte infusion in treating patients with multiple myeloma.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Azacitidine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion criteria:
* Patients with a diagnosis of multiple myeloma, who have residual measurable disease (in partial remission or with stable disease) and are eligible to undergo an autologous stem cell transplant will be able to participate in this trial; measurable disease will comprise of either, quantifiable serum or urinary, M protein or free light chains in the presence of a positive immunofixation or bone marrow plasma cells > 5%
* Patients who have received prior lenalidomide therapy will be eligible if >= partial response (PR) was observed on a prior lenalidomide containing regimen and patients did not progress while receiving lenalidomide; isolated bone lytic lesions in the absence of measurable para-proteins will not be considered measurable disease
* A minimum period of two weeks must have elapsed following the prior myeloma therapy; this does not include therapy with bisphosphonates
* Eastern Cooperative Oncology Group (ECOG) performance status =< 2
* No clinical evidence of uncontrolled viral, fungal, bacterial infection
* Negative serology for human immunodeficiency virus (HIV)
* Serum bilirubin =< 1.5 times upper limit of normal (ULN)
* Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) =< 3x ULN
* Calculated creatinine clearance >= 60ml/min by Cockcroft-Gault formula; creatinine clearance >= 60 ml/min or serum creatinine =< 2.0 mg/dL
* Absolute neutrophil count (ANC) >= 1500/uL
* Platelet count >= 100,000/ uL
* Hemoglobin (Hgb) >= 10 g/dL following recovery from last therapy
* Cardiac and pulmonary function adequate for transplant
* Ability to sign informed consent
* All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 <= age <= 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing
* Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
Exclusion criteria:
* Known or suspected hypersensitivity to azacitidine or mannitol
* Patients with multiple myeloma refractory to therapy with lenalidomide; progression following discontinuation of prior therapy with lenalidomide is allowed as long as patients have not failed rechallenge with lenalidomide
* Pregnant or breast feeding
* Other concomitant malignancies
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
* Concurrent use of other anti-cancer agents or treatments
* Known hypersensitivity to thalidomide or lenalidomide
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NCT_ID
NCT01050790
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Study_NameLenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma
| 16,434 |
Study Objectives
This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Platinum-based chemotherapy, DRUG: Bevacizumab [Avastin]
Location: Poland, United Kingdom, Australia, Austria, Lithuania, Denmark, Ecuador, Egypt, France, Slovenia, Lebanon, Netherlands, Canada, Turkey, China, Slovakia, Estonia, Venezuela, Portugal, Bosnia and Herzegovina, Germany, Sweden, Spain, Czech Republic, Italy, Taiwan, Mexico, Romania, Switzerland, Hong Kong, Argentina, Israel, Iceland, Brazil, Latvia, Serbia, Russian Federation, Colombia, Finland, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* adult patients, >=18 years;
* histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
* ECOG PS status 0 <= age <= 2;
* life expectancy >= 12weeks;
* adequate renal, liver and hematological function.
Exclusion Criteria:
* mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
* hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
* evidence of tumor invading major blood vessels on imaging;
* evidence of CNS metastases, even if previously treated.
* major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
* prior chemotherapy for stage IIIb/IV disease.
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NCT_ID
NCT00451906
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Study_NameA Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
| 15,006 |
Study Objectives
The goal of this part (Part 1) of this clinical research study is to learn about the safety of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients with bladder cancer that has come back. The goal of Part 2 of this study is to learn about the safety of giving 2 more doses of SCH 72105 directly into the bladder of Part 1 participants who had no sign of bladder cancer after Week 12. The level of effectiveness of SCH 72105 will also be studied by measuring the interferon (IFN) levels in the urine.
Conditions: Bladder Cancer
Intervention / Treatment:
DRUG: SCH 721015
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules.
* Histologically proven recurrent urothelial carcinoma of the bladder or prostatic urethra, Stage Tis, Ta
* Patients with recurrent T1 disease who do not wish to have cystectomy.
* Subjects must have failed at least two prior courses of BCG with or without recombinant interferon alpha administration or be BCG intolerant. This includes either two six week induction courses of BCG or a 6 week induction course followed by a 3 week mini-induction course of maintenance BCG.
* At least 3 months must have passed since last BCG therapy or intravesical treatment for bladder carcinoma.
* Subjects must be 18 years or older
* Life expectancy of at least 3 months
* Adequate performance status (Karnofsky score >= 70%)
* Adequate laboratory values. a) Hemoglobin >=10 gm/dL. b) White blood cell count (WBC) >= 3000/µL. c) Absolute neutrophil count (ANC) >= 1500/µL. d) Platelet count >=100,000/µL. e) PT <= 1.5 x upper limit of normal (ULN). f) Activated partial thromboplastin time (aPTT) <= 1.5 x ULN. g) AST <=1.5 x ULN. h) ALT <= 1.5 x ULN. i) Total bilirubin <= 1.5 x ULN. j) Creatinine <=1.5 x ULN.
* Female subjects of childbearing potential (Female subjects who are not surgically sterilized, not at least 1 year postmenopausal) must agree to use adequate contraception (e.g. intrauterine device (IUD), condom plus spermicide, diaphragm, or cervical cap plus spermicide) or medical contraception: during the study and for at least 1 month prior to drug administration and for 4 months after treatment. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the Study.
* Male subjects who are sexually active must agree to use a condom from the beginning of treatment and for 1 month after the last dose
Exclusion Criteria:
* Pregnant or nursing women
* Suspected hypersensitivity to interferon alpha
* Participation in another clinical trial or use of any investigational drug within 30 days prior to study entry
* Subjects with organ transplants
* Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as:
* b. Central nervous system (CNS) trauma or active seizure disorders requiring medication
* c. Significant cardiovascular dysfunction within the past 6 months including symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring hospitalization or emergency room visit within last 3 months
* d. Poorly controlled diabetes mellitus (HbA1C >10.0%);
* e. Unstable pulmonary disease requiring hospitalization or emergency room visit within the last 3 months.
* f. Immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis, immune mediated glomerulonephritis).
* Donation of blood within the preceding 60 days prior to study registration.
* Any other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the protocol.
* History of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration
* Untreated bladder infection
* Positive for hepatitis BsAg or HIV Ab or hepatitis C
* Immunosuppressive therapy within the last 3 months
* Subjects who are part of the staff personnel directly involved with this study
* Subjects who are family members of the investigational study staff
* Traumatic catheterization within 1 month
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NCT_ID
NCT01162785
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Study_Name1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer
| 19,290 |
Study Objectives
This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly administered a single 10.0 mCi dose of 123I-MIP-1072 or 123I-MIP-1095 (study drugs). The second (alternate) study drug will be administered approximately 14 days after the first. A final follow-up visit will occur approximately 2 weeks after the injection of the alternate study drug.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: 123-I-MIP-1072, DRUG: 123-I-MIP-1095
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: SINGLE
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Inclusion Criteria:
* Have a prior histological diagnosis of prostate cancer.
* Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus:
1. PSA> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or
2. PSA> 20 if intact prostate
* Have platelet count of > 50,000/mm3
* Have neutrophil count of > 1,000/mm3
* Provide written informed consent and willing to comply with protocol requirements
* Greater than or equal to 18 years
* Can be on hormonal therapy if dose stable for > 90 days
Exclusion Criteria:
* Karnofsky performance status of <60
* Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
* Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants).
* Patient received external beam therapy or chemotherapy within the last 30 days
* Administered a radioisotope within 5 physical half lives prior to study enrollment
* Serum creatinine > 3.5 mg/dL
* Total bilirubin > 2.5 times the upper limit of normal
* Liver transaminases greater than 5x the upper limit of normal
* Received an investigational compound and/or medical device or is part of an investigational study within the past 30 days before enrollment into this study
* Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
* Is determined by the Investigator that the patient is clinically unsuitable for the study
* Have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin.
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NCT_ID
NCT00712829
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Study_NameStudy to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents
| 1,464 |
Study Objectives
Primary Objectives:
* Phase I: To evaluate safety and tolerability of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.
* Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.
Secondary Objectives:
* To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events were assessed.
* To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule.
* To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria.
* To assess the relationship between Baseline cluster of differentiation 38 (CD38) receptor density on multiple myeloma cells and efficacy.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Isatuximab SAR650984
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
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Inclusion criteria:
* Males or females, age >= 20 years.
* Participants had a known diagnosis of symptomatic multiple myeloma.
* Participants had received at least 3 prior lines of therapies OR participants whose disease was double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI).
* Participants had been responsive (i.e., minimal response [MR] or better) to at least one prior line of therapy.
* Refractory to the most recently received IMiD or PI included therapy.
* Participants with measurable disease defined as at least one of the following:
* Immunoglobulin G (IgG) Type: Serum M-protein >=1 gram per deciliter (g/dL) (>=10 g/L);
* Immunoglobulin A (IgA) and D Type: Serum M-protein, quantification should be performed;
* Urine M-protein >=200 mg/24 hours.
* Participants with a Eastern Cooperative Oncology Group (ECOG) performance status <=2.
Exclusion criteria:
* Participants treated with any anti-CD38 agent.
* Diagnosed or treated for another malignancy within 5 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low-risk prostate cancer after curative therapy.
* Prior anticancer therapy (chemotherapy, targeted agents, immunotherapy) within 21 days prior to the first drug infusion unless otherwise specified below:
* Alkylating agents (e.g., Melphalan) within 28 days prior to the first dose of study treatment.
* Steroids treatment (e.g., prednisone greater than (>)10 mg/day orally or equivalent except patients being treated for adrenal insufficiency/replacement therapy or treated for inhalation corticosteroids) within 14 days prior to the first dose of study treatment.
* Participated in another clinical trial within 30 days prior to the first dose of study treatment.
* Participants treated with systemic radiation therapy within 4 weeks prior to the first dose of study treatment OR Localized radiation therapy within 1 week prior to the first dose of study treatment.
* Major surgical procedure within 4 weeks prior to the first dose of study treatment.
* Any toxicity Grade >=2 (excluding alopecia, neutropenia or neuropathy) related to any prior anti-cancer therapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
* Neuropathy Grade >=3 or painful peripheral neuropathy Grade >=2.
* History of significant cardiovascular disease unless the disease within the past 6 months was well-controlled.
* Previously received an allogenic stem cell transplant.
* Diagnosed Crow-Fukase (POEMS) syndrome OR plasma cell leukemia.
* Participants with known or suspected amyloidosis.
* Participants with Waldenstrom's macroglobulinemia OR Multiple myeloma IgM subtype.
* Participants with active infection.
* Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection.
* Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.
* Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results.
* Hypersensitivity or history of intolerance to boron or mannitol, sucrose, histidine (as base and hydrochloride salt) and polysorbate 80 or any of the components of study therapy that are not amenable to pre-medication with steroids and H2 blockers or would prohibit further treatment with these agents.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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NCT_ID
NCT02812706
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Study_NameIsatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients
| 12,279 |
Study Objectives
This phase II trial is studying how well giving UCN-01 together with topotecan works in treating patients with small cell lung cancer that relapsed or progressed after previous chemotherapy. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. UCN-01 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also increase the effectiveness of topotecan by making tumor cells more sensitive to the drug. Giving UCN-01 together with topotecan may kill more tumor cells.
Conditions: Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
Intervention / Treatment:
DRUG: topotecan hydrochloride, DRUG: 7-hydroxystaurosporine
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Patients must have histologically confirmed extensive stage small cell lung cancer that is incurable but amenable to treatment with chemotherapy
* Patients must have measurable disease as defined by the Response Evaluation Criteria in Solid Tumours (RECIST); they must have either measurable disease outside the field or progression post radiation therapy
* Patient must have received ONLY first-line platinum-based chemotherapy and relapsed or progressed >= 3 months post completion of therapy (patients with chemo-sensitive disease)
* Patient must have completed any prior chemotherapy at least 3 months before study entry, have completed surgery or radiotherapy at least 4 weeks before study entry and must have recovered from the toxic effects from any prior therapy; patient must not have had more than 40% of their bone marrow radiated
* ECOG performance status =< 2 (Karnofsky >= 60%)
* Leucocytes >= 3 x 10^9/L OR
* ANC >= 1.5 x 10^9/L
* Platelets >= 100 x 10^9/L
* Total serum bilirubin =< 1.5 x UNL
* AST/ALT =< 3 x UNL (=< 5 x UNL if documented liver metastases)
* Creatinine =< institutional upper limit of normal OR creatinine clearance >= 50 ml/min/1.73m^2 for patients with creatinine levels above institutional normal
* The effects of UCN-01 on the developing human fetus are unknown; for this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; contraception should be continued at least 3 months after the last dose of UCN-01; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients who have had prior therapy with a topoisomerase I inhibitor (topotecan or irinotecan) will be excluded
* Patients who have had other chemotherapy regimens other than first-line platinum-based chemotherapy will be excluded
* Patients may not be receiving any other investigational agents
* Patients may not be receiving concurrent radiation therapy while on study treatment
* Patients with uncontrolled/symptomatic CNS metastases; routine CT scans are not required to rule these out except when there is clinical suspicion of CNS disease
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to UCN-01 or other agents used in study
* Because of cardiopulmonary toxicity seen in patients on other studies, patients with a history of coronary artery disease and/or symptomatic cardiac dysfunction should be excluded
* Because UCN-01 may cause hyperglycemia, patients with insulin dependent diabetes mellitus will be excluded; patients with diet-controlled diabetes mellitus or those on oral hypoglycemic agents can be entered at the discretion of the investigator
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study because UCN-01 is a serine-threonine kinase inhibitor with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with UCN-01, breastfeeding should be discontinued if the mother is treated with UCN-01; these potential risks may also apply to other agents used in this study
* Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with UCN-01 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
* Patients may not have had any other active malignancy in the past 5 years except for cervical carcinoma in situ and non-melanomatous skin cancer
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NCT_ID
NCT00098956
|
Study_Name7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer
| 19,357 |
Study Objectives
The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with non-small cell lung cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.
Conditions: Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: ABT-751
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria
* Stage IIIB or IV non-small cell lung cancer.
* Recurrent tumor following treatment with paclitaxel or docetaxel.
* Able to tolerate normal activities of daily living.
* Adequate bone marrow, kidney and liver function.
Exclusion Criteria
* Pregnant or breast feeding.
* Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
* CNS metastasis.
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NCT_ID
NCT00073151
|
Study_NameA Study of ABT-751 in Patients With Non-Small Cell Lung Cancer
| 21,901 |
Study Objectives
The purpose of this study is to evaluate the effect of treatment with epoetin alfa versus placebo on the percentage of red blood cells in anemic patients with chronic lymphocytic (white blood cell) leukemia and its effect on the patients' quality-of-life. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Conditions: Anemia, Leukemia, Lymphocytic, Chronic, Leukemia, Lymphocytic, Cancer, Neoplasms, Quality of Life
Intervention / Treatment:
DRUG: epoetin alfa
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Patients with chronic lymphocytic (white blood cell) leukemia
* having received either no cancer treatment, or treated with single-agent chemotherapy and/or prednisone for one month or a combination chemotherapy regimen
* having a Performance score of 0 (fully active, no disease restriction) to 3 (capable of only limited self-care, confined to bed or chair more than 50% of waking hours)
* having a life expectancy of at least 6 months
* having a hematocrit of <32%, a corrected reticulocyte count of <3%, platelets >25,000 cells/millimeter cubed, creatinine <2.0 mg/mL, a negative Coombs test (test for antibodies to red blood cells) and no occult blood in the stool
Exclusion Criteria:
* Patients with a clinically significant disease besides cancer
* having uncontrolled high blood pressure or a history of seizures
* received androgen therapy within 2 months of study
* received a transfusion within 1 week of study entry
* received radiation therapy within 1 month of study entry
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NCT_ID
NCT00270049
|
Study_NameEpoetin Alfa for the Treatment of Anemia Resulting From Chronic Lymphocytic Leukemia
| 14,982 |
Study Objectives
The goal of this clinical research study is to compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be studied.
Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die.
Conditions: Myeloma
Intervention / Treatment:
DRUG: Busulfan, DRUG: Melphalan, OTHER: Questionnaire, DRUG: G-CSF, DRUG: High Dose Melphalan, PROCEDURE: Stem cell transplant
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patients with multiple myeloma in complete remission (CR), partial remission (PR), or very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain MM detected in the serum by free light chain assay.
* Patients with non-secretory multiple myeloma [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis (SPEP) and immunofixation (SIFE) and the absence of Bence Jones protein in the urine (UPEP) defined by use of conventional electrophoresis and immunofixation (UIFE) techniques] but with measurable disease on imaging studies like MRI, CT scan or PET scan.
* Who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.
* 70 years or younger.
* Karnofsky performance score 70% or higher.
* Cardiac function: left ventricular ejection fraction at rest > 40% within 3 months of registration.
* Hepatic function: bilirubin < 2x the upper limit of normal and ALT and AST < 2.5x the upper limit of normal.
* Renal function: creatinine clearance of >= 40 mL/min, estimated or calculated.
* Pulmonary function: DLCO, FEV1, FVC >= 50% of predicted value (corrected for hemoglobin) within 3 months of registration
* Signed informed consent form.
Exclusion Criteria:
* Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
* Patients seropositive for the human immunodeficiency virus (HIV).
* Patients with history of myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* Patients participating in an investigational new drug protocol within 14 days before enrollment.
* Female patients who are pregnant (positive b-HCG) or breastfeeding.
* Prior stem cell transplantation allogeneic or autologous.
* Prior organ transplant requiring immunosuppressive therapy.
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NCT_ID
NCT01413178
|
Study_NameA Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
| 17,869 |
Study Objectives
This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted, ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute myelogenous leukemia (AML).
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
BIOLOGICAL: ALT-803
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Diagnosis of acute myeloid leukemia (AML) and meets one of the following disease criteria:
* Primary induction failure:
* De novo AML - no CR after 2 or more chemotherapy induction attempts
* Secondary AML (from MDS or treatment related): no CR after 1 or more chemotherapy induction attempts
* Relapse after chemotherapy: not in CR after 1, 2, or 3 re-induction attempts
* Patients > 60 years, the 1 cycle of chemotherapy is not required
* Relapse after hematopoietic stem cell transplant:
* Relapse must have occurred > 18 months after transplant
* No re-induction required and no more than 1 re-induction attempt is allowed
* Notes:
1. For hypomethylating agents (i.e. decitabine, azacitidine) to count as an induction/re-induction attempt, the patient must have completed a minimum of 3 monthly cycles
2. For targeting agents (i.e. sorafenib) to count as an induction/re-induction attempt, the patient must have completed a minimum of 1 month without attaining CR
3. 7+3 followed by 5+2 counts as TWO induction attempts
4. Use of hydroxyurea is permitted to control blasts until Day -3 per Section 8.7
5. A history of AML related CNS involvement is allowed if CSF analysis is negative on 2 test dates at least 2 weeks apart prior to study treatment. The use of ongoing CNS maintenance therapy is allowed while on study.
* HLA-haploidentical related donor (aged 12 <= age <= 75) with donor/recipient match based on a minimum of intermediate resolution DNA based Class I typing of the A and B locus (at least 2/4 class I allele)
* Karnofsky Performance Status >= 60%
* Adequate organ function within 14 days of study registration (28 days for pulmonary and cardiac) defined as:
* Creatinine: <= 2.0 mg/dL
* Hepatic: AST and ALT < 3 x upper limit of institutional normal
* Pulmonary Function: oxygen saturation >= 90% on room air; PFT's required only if symptomatic or prior known impairment - must have pulmonary function >50% corrected DLCO and FEV1.
* Cardiac Function: LVEF >= 40% by echocardiography, MUGA or cardiac MRI, no uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* Able to be off prednisone or other systemic immunosuppressive medications for at least 3 days prior to NK cell infusion (excluding preparative regimen pre-medications) .
* Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy .
* Voluntary written consent prior to the performance of any research related procedures.
Exclusion Criteria:
* Acute leukemias of ambiguous lineage
* Pregnant or breastfeeding - The agents used in this study include those that fall under Pregnancy Category D - have known teratogenic potential. Women of child bearing potential must have a negative pregnancy test at screening
* Active autoimmune disease requiring systemic immunosuppressive therapy
* History of severe asthma and currently on systemic chronic medications (mild asthma requiring inhaled steroids only is eligible)
* New or progressive pulmonary infiltrates on screening chest X-ray or chest CT scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).
* Uncontrolled bacterial, fungal or viral infections including HIV-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
* Received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine)
* Prior ALT-803
|
NCT_ID
NCT03050216
|
Study_NameQUILT-3.033: Haplo NK With SQ ALT-803 for Adults With Relapsed or Refractory AML
| 7,417 |
Study Objectives
This is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Participants will also provide a waist circumference measurement at Baseline and Week 12.
Conditions: Polycystic Ovary Syndrome, Hormone Imbalance
Intervention / Treatment:
DIETARY_SUPPLEMENT: Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: OTHER
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Women aged between 18 - 55
* BMI less than 35
* Self-reported symptoms of PCOS like irregular periods, excessive hair growth, weight gain, oily skin, or acne
* Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
* Self-reported concerns with hormonal skin issues
* Has access to a tape measure for waist measurement
* Generally healthy - don't live with any uncontrolled chronic disease
Exclusion Criteria:
* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
* Anyone with known severe allergic reactions
* Anyone who is pregnant or breastfeeding
* Unwilling to follow the study protocol
|
NCT_ID
NCT06158932
|
Study_NameA Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance
| 15,335 |
Study Objectives
This study is for elderly patients who haven't been given prior chemotherapy or for patients who cannot be treated with platinum based chemotherapy. The patients who are eligible for this study will have been diagnosed with advanced or metastatic non-small cell lung cancer. The patients will be randomly assigned to one of two treatment options: single agent pemetrexed or single agent pemetrexed with single agent gemcitabine following right after the pemetrexed treatment.
Conditions: Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: pemetrexed, DRUG: gemcitabine
Location: Italy, Germany, United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* histologically or cytologically confirmed NSCLC not amenable to surgery or radiotherapy of curative intent
* locally advanced or metastatic Stage IIIb (with N3 supraclavicular or T4 for pleural effusion) or IV NSCLC
* no prior chemotherapy
* measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Therasse et al. 2000)
* men and women greater than or equal to 70 years or patients who, in the investigator's opinion, are not eligible for platinum-based chemotherapy
Exclusion Criteria:
* have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* have symptomatic brain metastases
* have a history or presence of other malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
* are unable to interrupt therapy with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen, piroxicam, diflunisal, or nabumetone around each dose of pemetrexed (5 days for short-acting or 8 days for long acting preparations)
* are unable or unwilling to take steroids
* are unable or unwilling to take folic acid or vitamin B12 supplementation
* have clinically detectable (by physical examination) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
* have other serious concomitant illness or medical conditions according to investigator criteria, including but not limited to the following:
* congestive heart failure or angina pectoris, except if it is medically controlled
* previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or arrhythmias
* active infection requiring iv antibiotics
* active ulcer, unstable diabetes mellitus, or other contra-indication to corticotherapy
* superior vena cava syndrome
|
NCT_ID
NCT00489983
|
Study_NameTrial of Pemetrexed or Pemetrexed With Gemcitabine for Patients With Advanced Lung Cancer Who Are Not Eligible for Platinum-Based Chemotherapy and Have Not Previously Been Treated With Chemotherapy
| 20,844 |
Study Objectives
The purpose of this phase III study is to determine whether Doxorubicin Transdrug (DT) is effective in the treatment of patients suffering from advanced Hepatocellular Carcinoma (HCC) after failure or intolerance to Sorafenib. Patients with HCC with or without cirrhosis and with good liver functions are eligible. Only those who can not benefit from treatment for which efficacy is demonstrated are eligible.
These patients are usually proposed either best standard of care (BSC) or participation to clinical trials. Patients eligible for the RELIVE study will receive either DT at 20 mg/m2 or DT at 30 mg/m2 or the BSC.
Conditions: Carcinoma, Hepatocellular
Intervention / Treatment:
DRUG: Doxorubicin 20 mg/m2, DRUG: Doxorubicin 30 mg/m2, DRUG: Best Standard of Care
Location: Germany, Lebanon, United States, Spain, Italy, Austria, Belgium, Turkey, Egypt, France, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Male or non-pregnant, non-breast feeding female;
* Aged >= 18 years;
* Patient with:
* advanced HCC (BCLC-C according to BCLC staging classification) having progressed under Sorafenib therapy or intolerant to Sorafenib, or;
* intermediate HCC (BCLC-B) non eligible or non responders to transarterial chemoembolization (TACE), and having progressed under or intolerant to Sorafenib therapy
* Patients with porta hepatis lymph nodes, extrahepatic metastases, or portal/suprahepatic vein thrombosis without extension in inferior/superior vena cava, are eligible;
* HCC diagnosed according to the American Association for Study of Liver Diseases (AASLD) and/or European Association for the Study of the Liver (EASL) criteria:
* Radiological Criteria applicable in cirrhotic liver:
* Nodule >= 10 mm: one imaging technique among MRI and CT-scan showing typical appearances for HCC defined as arterial enhancement and rapid washout in portal venous or delayed phase;
* If appearance not typical for HCC on initial imaging: second contrast enhanced study (CT or MRI) showing typical appearances for HCC defined as arterial enhancement and rapid wash-out in portal venous or delayed phase;
* And/Or cyto-histology criteria (e.g. in case of atypical lesions for HCC at imaging, absence of cirrhosis);
* Without cirrhosis or with a non decompensated cirrhosis (Child-Pugh score from A5 to B7 included);
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
* Laboratory tests as follows:
* Platelets >= 50,000 /mm3
* Neutrophil count >= 1000/mm3
* Hemoglobin >= 10g/dL
* Serum transaminases < 5 upper limit normal (ULN) (NCI/common toxicity criteria (CTC) grades 0, 1, or 2)
* Alkaline phosphatases < 5 ULN (NCI/CTC grades 0, 1, or 2)
* Serum bilirubin < 35 micromolar (µM)/L (or 2.0 mg/dL);
* Signed and dated written informed consent form.
Exclusion Criteria:
* Cirrhosis with a Child-Pugh score B8-C15;
* Untreated chronic hepatitis B;
* Patients eligible for curative treatments (transplantation, surgical resection, percutaneous treatment);
* Patients eligible for palliative treatments with demonstrated efficacy: TACE, Sorafenib; Patients who failed to Sorafenib treatment or intolerant to sorafenib are eligible and can be included if Sorafenib has been stopped at least 2 weeks before randomization;
* Prior history of malignancy with the exception of adequately treated basal cell carcinoma or in situ cervical cancer in complete remission since five years at least;
* HCC developed on transplanted liver;
* HIV infection;
* Risk of variceal bleeding;
* Oxygen saturation (SaO2) < 95%;
* Presence of a significant acute or chronic respiratory disease defined as NCI/CTCAE > grade 2;
* Presence of recent (< 6 months) or current cardiac failure (class III or IV New York Heart Association (NYHA) classification), recent (< 6 months) acute coronary syndrome, clinically significant ECG abnormalities or recent (less than 6 months) acute vascular diseases (stroke, myocardial infarction (MI)...);
* Prior cumulative dose of 300 mg/m² of doxorubicin or equivalent;
* Patients currently treated with immunosuppressive agents that cannot be stopped;
* Patients whose medical or surgical conditions are unstable and may not allow the study completion or compliance, and specially patients with uncontrolled diabetes;
* Uncontrolled systemic infection;
* Patients with a life expectancy of less than 2 months;
* Patients who have received an experimental drug in another clinical trial in the last 30 days prior to randomization in the present clinical trial;
* Women of child-bearing age who are unwilling or unable to use an effective contraception method during the study treatment period and for 6 months after the last administration of study drug, and their male partner(s) refusing to use a condom (if applicable);
* Men who are unwilling or unable to use a condom during the study treatment period and for 6 months after the last administration of study drug, and their female partner(s) refusing to use one of the appropriate effective contraception methods (if applicable);
* Patients unwilling or unable to comply with protocol requirements and scheduled visits.
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NCT_ID
NCT01655693
|
Study_NameEfficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma
| 19,645 |
Study Objectives
The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCR in children with high-risk neuroblastoma. In the present study, a single arm trial of tandem HDCT/ASCR will be carried out. In the present study, the investigators will investigate whether tandem HDCT/ASCR might improve the survival of patients with high-risk neuroblastoma with acceptable toxicity.
Conditions: Neuroblastoma
Intervention / Treatment:
DRUG: Cyclophosphamide, DRUG: Etoposide, DRUG: Carboplatin, DRUG: Thiotepa, DRUG: Melphalan, RADIATION: Total body irradiation
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with high-risk neuroblastoma
* Patients with intermediate-risk neuroblastoma if gross tumor remained after surgery
Exclusion Criteria:
* Patients with progressive disease before high-dose chemotherapy
* Patients whose parents want to stop or change the planned treatment
* Patients with organ toxicities of NCI grade >2 before high-dose chemotherapy
|
NCT_ID
NCT00793845
|
Study_NameTandem High-dose Chemotherapy and Autologous Stem Cell Rescue in Patients With High-risk Neuroblastoma
| 22,429 |
Study Objectives
The purpose of this study is to compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of actinic keratosis.
Conditions: Actinic Keratosis
Intervention / Treatment:
DRUG: Ingenol Mebutate (Perrigo), DRUG: Ingenol Mebutate (Reference), DRUG: Placebo gel
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria
* Provide written informed consent/assent
* Healthy male or non-pregnant females, >18 years
* Subjects must have clinical diagnosis of actinic keratosis
* Subjects must be in general good health and free from any clinically significant disease that might interfere with the study evaluations in the opinion of the investigator
* Subjects must be willing to refrain from using non-approved products on the targeted treatment area during the study period.
* Subjects should be willing to refrain from using any type of bandage or dressing on the treatment area or apply the gel to open skin wounds, infections, or exfoliative dermatitis.
* Subjects must be willing and able to comply with the requirements of the study for the duration of the study period.
* Females of childbearing potential willing to use an acceptable form of birth control
Exclusion
* Females who are pregnant, nursing, or planning a pregnancy within the study participation period
* Subjects who are immunocompromised or HIV positive or who have any immune-system disorders including auto-immune disease
* Subjects who have or had an active herpes infection within 14 days prior to the baseline visit
* Subjects who have any evidence of carcinoma or any other cancer on the face and scalp
* Presence of an incompletely healed wound within the treatment area or within 5cm of the treatment area
* Presence of any skin condition in the treatment area that may be made worse by treatment with the study medication
* Subjects who have used a tanning salon, tanning booth, sunbathing or have excessive prolonged exposure to the sun 7 days prior to Visit 1/Day 1 (baseline) or planned throughout the study
* Subjects who plan to use artificial tanners within 5cm of the selected treatment area throughout the study
* Use of NSAIDs within 7 days from Visit 1/Day 1 (Baseline) or initiation during the trial.
* Subjects who had select cosmetic or therapeutic procedures within 2cm of the selected treatment area and within 14 days of Visit 1/Day 1 (baseline) or within 10cm of the selected treatment area planned anytime during the study.
* Subjects who have had or are scheduling elective surgery within 1 month before or after the study period
* Prior use within 30 days of Visit 1/ Day 1 (baseline) or planned use during the study of immunomodulators, immunosuppressive therapies, interferon, interferon inducers, systemic corticosteroids, and cytotoxic drugs
* Subjects undergoing treatment or received treatment within 8 weeks of Visit 1/Day 1 (baseline) and within 2cm of the selected area or planned during anytime in the study of: 5-FU, imiquimod, diclofenac, photodynamic therapy used in combination with photosensitizing cream.
* Subjects who used PUVA or UVB therapy on the face or scalp within 6 months prior to Visit 1/Day 1 (baseline) or are planning to receive PUVA therapy, UVB therapy, or nonprescription UV light sources anywhere on the body during the study.
* Subjects who have taken systemic chemotherapy medications within the last 6 months prior to Visit 1/Day 1 (baseline) or planned use anytime during the study.
* Subjects who have undergone resurfacing procedures within the last 6 months prior to Visit 1/Day 1 (baseline) or planned use anytime during the study.
* Subjects who have been treated within 1 month or planning to receive treatment with systemic retinoids, hyaluronic acid, other medicated actinic keratosis therapy, or topical steroids anywhere on the head during the study.
* Subject who have a history of hypersensitivity or allergy to any ingredient in the drug product.
* Use of medicated make-up in the treatment area or significant change in the use of consumer products within 30 days of Visit 1/Day 1 (baseline) and planned use or change throughout the study.
* Start or change of dose of hormonal treatment within the past 3 months (90 days) or planned start/change throughout the study.
* Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
* Participation in any clinical study involving an investigational product, agent, or device in the 30 days prior to Visit 1/Day 1 (baseline) or throughout the study
* Subjects who have been previously enrolled in this study
* Employee of the research center or private practice
* Subjects who in the opinion of the investigator are unlikely to be able to follow the restrictions of the protocol and complete the study
|
NCT_ID
NCT02385318
|
Study_NameTo Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis
| 8,203 |
Study Objectives
The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.
Conditions: Cancer
Intervention / Treatment:
DRUG: IC83/LY2603618, DRUG: IC83/LY2603618, DRUG: IC83/LY2603618, DRUG: IC83/LY2603618, DRUG: IC83/LY2603618, DRUG: pemetrexed, DRUG: pemetrexed
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Has at least one lesion that can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
* Has fully recovered from all toxicities due to the following:
1. Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1.
2. Surgery.
* Has a life expectancy of at least 3 months.
* Negative serum pregnancy test.
Exclusion Criteria:
* Is pregnant or breastfeeding.
* Is a woman of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
* Is a man of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
* Has a history of brain metastases, unless adequately treated and without radiologic evidence of progressive disease for at least 3 months after completion of therapy.
* Has a known active infection.
|
NCT_ID
NCT00415636
|
Study_NameSafety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
| 8,489 |
Study Objectives
The objective is to treat elderly AML and MDS patients with sapacitabine.
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Sapacitabine, Arm A, DRUG: Sapacitabine, Arm B, DRUG: Sapacitabine, Arm C, DRUG: Sapacitabine, Arm D, DRUG: sapacitabine, Arm E, DRUG: sapacitabine, Arm F, DRUG: Sapacitabine, Arm G, DRUG: Sapacitabine, Arm H, DRUG: Sapacitabine, Arm I
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* A histologically or pathologically confirmed diagnosis of AML based on WHO classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents
* Age >= 70 years for AML and >= 60 years for MDS
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2
* Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (ULN)
* Adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver)
* Life expectancy reasonably adequate for evaluating the treatment effect
* Patient must be able to swallow capsules
* Patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments
* All men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists
* Ability to understand and willingness to sign the informed consent form
Exclusion Criteria:
* AML is of the sub-type of acute promyelocytic leukemia
* Having received more than one induction systemic therapy for AML or having received a standard dose or high dose ara-C containing regimen for MDS
* Patients with known central nervous system (CNS) involvement by leukemia
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than AML, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients receiving intravenous antibiotics for infections that are under control may be included in this study
* Known to be HIV-positive
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NCT_ID
NCT00590187
|
Study_NameEfficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
| 18,802 |
Study Objectives
This phase II trial studies how well second mitochondrial-derived activator of caspases (SMAC) mimetic LCL161 alone or with cyclophosphamide works in treating patients with multiple myeloma that has returned or does not respond to treatment. Biological therapies, such as SMAC mimetic LCL161, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving SMAC mimetic LCL161 alone or with cyclophosphamide is more effective in treating multiple myeloma.
Conditions: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Intervention / Treatment:
DRUG: Cyclophosphamide, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, OTHER: Quality-of-Life Assessment, DRUG: Smac Mimetic LCL161
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Relapsed or refractory multiple myeloma and has already received =< 4 standard treatment regimens; note: induction, transplant, consolidation, and maintenance is considered one regimen
* Have received prior therapy with an immunomodulatory agent, a proteosome inhibitor, and glucocorticoids
* Absolute neutrophil count (ANC) >= 1000/uL
* Untransfused platelet count >= 75,000/uL
* Aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) =< 3 x ULN
* Total bilirubin =< 1.5 mg/dL
* Serum creatinine =< 2.5 mg/dL
* Hemoglobin >= 8 g/dL
* Measurable disease of multiple myeloma as defined by at least ONE of the following:
* Serum monoclonal protein >= 1.0 g/dL
* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
* Monoclonal plasmacytosis >= 30% (evaluable disease)
* Measurable plasmacytoma that has not been radiated
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
* Willing and able to comply with scheduled visits, treatment plan and laboratory tests
* Able to swallow and retain oral medication
* Provide informed written consent
* Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
* Willing to provide all biological specimens as required by the protocol for correlative research purposes
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Mayo Clinic Arizona only: Willing to participate in associated biobanking study, 919 <= age <= 04; the patient must sign consent to enroll onto the mandatory companion biobanking study in order to participate in this treatment study
* Mayo Clinic Rochester and Florida only: Willing to participate in associated biobanking study, 521 <= age <= 93; the patient must sign consent to enroll onto the mandatory companion biobanking study in order to participate in this treatment study
Exclusion Criteria:
* Prior use of investigational drugs =< 14 days prior to registration
* Prior use of growth factors =< 14 days prior to registration
* Prior radiation therapy =< 14 days prior to registration
* Prior autologous stem cell transplant =< 12 weeks prior to registration
* Any of the following:
* Pregnant women
* Nursing women
* Women of childbearing potential who are unwilling to employ adequate contraception while receiving treatment on this study and for 4 months after stopping treatment on this study
* Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while receiving treatment on this study and for 4 months after stopping treatment on this study NOTE: Postmenopausal women are allowed to participate in this study; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, a woman is considered to be of not child bearing potential only when her reproductive status has been confirmed by follow-up hormone level assessment
* Prior allogeneic transplant of any kind
* Known active infection requiring parenteral or oral anti-infective treatment
* Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation
* Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection
* Active autoimmune/inflammatory conditions requiring ongoing immunosuppressive therapy
* Use of more than low dose corticosteroids (e.g., prednisone up to but no more than 10 mg PO QD or its equivalent) for symptom management and comorbid conditions, except for the following:
* Topical applications (e.g. rash)
* Inhaled sprays (e.g. obstructive airways diseases)
* Eye drops or local injections (e.g. intra-articular)
* Joint injections (e.g. arthritis) Doses of corticosteroid should be stable for at least 7 days prior to registration
* Any concurrent severe and/or uncontrolled medical conditions that could increase the patient's risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities
* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
* History or presence of ventricular tachyarrhythmia
* Presence of unstable atrial fibrillation (ventricular response > 100 bpm) (NOTE: patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria)
* Clinically significant resting bradycardia (< 50 bpm)
* Angina pectoris or acute myocardial infarction =< 3 months prior to registration
* Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen)
* Currently receiving treatment with agents that are metabolized solely through cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) and have a narrow therapeutic index or are strong cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors; or are receiving treatment with agents that carry a risk for QT prolongation and are CYP3A substrates; caution should be used in patients taking other CYP2C8- or CYP3A4/5-interacting agents
* Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LCL161
|
NCT_ID
NCT01955434
|
Study_NameSMAC Mimetic LCL161 Alone or With Cyclophosphamide in Treating Patients With Relapsed or Refractory Multiple Myeloma
| 10,252 |
Study Objectives
The study is an open-label phase 2 clinical and translational trial designed to evaluate the effects of nilotinib on the leukemic stem cell population in subjects with newly diagnosed chronic phase chronic myeloid leukemia (Ph+ CML in CP). Nilotinib is FDA-approved to treat subjects with Ph+ CML in CP. Subjects on study will be monitored according to accepted National Cancer Comprehensive Network \[NCCN\] clinical guidelines for 24 months. After 24 months, if continued therapy is needed subjects will be transitioned to commercial supply of study drug.
Conditions: Chronic Myeloid Leukemia
Intervention / Treatment:
DRUG: Nilotinib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: BASIC_SCIENCE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients >= 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance status 0,1, or 2
* Documented diagnosis of Ph+ Chronic phase CML:
* Chronic phase: None of the criteria for accelerated or blastic phase
* Accelerated phase
1. Blasts >= 15% in blood or BM
2. Blasts plus progranulocytes >= 30% in blood or bone marrow (BM)
3. Basophilia >= 20% in blood or BM
4. Platelets < 100 × 109/L unrelated to therapy
5. Cytogenetic clonal evolution
* Blast phase
1. >= 30% blasts in blood or BM
2. Extramedullary disease with localized immature blasts
* Adequate end organ function, defined as the following:
* Creatinine < 1.5 x upper limit of normal (ULN)
* Absolute neutrophil count (ANC) > 1.5 x 109/L
* Platelets > 100 x 109/L
* Total bilirubin < 1.5 x ULN (Does not apply to patients with isolated hyperbilirubinemia [e.g., Gilbert's disease] grade <3)
* Aspartate aminotransferase (AST) (SGOT) and Alanine aminostransferase (ALT) (SGPT) < 3 x ULN
* Serum amylase and lipase <= 2 x ULN
* Alkaline phosphatase <= 2.5 x ULN
* Patients must have the following laboratory values (WNL = within normal limits at the local institution lab) or corrected to within normal limits with supplements prior to the first dose of study medication:
1. Potassium (WNL)
2. Magnesium (WNL)
3. Phosphorus (WNL)
4. Calcium (WNL)
Exclusion Criteria:
* Previous treatment with any other tyrosine kinase inhibitor except for up to 2 weeks of nilotinib
* Impaired cardiac function including any one of the following:
* Inability to monitor the QT interval on ECG
* Congenital long QT syndrome or a known family history of long QT syndrome.
* Clinically significant resting brachycardia (<50 beats per minute)
* Q-T Corrected (corrected Q-T interval) (QTc) > 450 msec on baseline ECG. If QTc >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc
* Myocardial infarction within 12 months prior to starting study Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension)
* History of or presence of clinically significant ventricular or atrial tachyarrhythmias
* Complete left bundle branch block
* Right bundle branch block plus left anterior/posterior hemiblock
* Use of ventricular-paced pacemaker
* History of unstable angina within 1 year of study entry
* Patients currently receiving treatment with strong CYP3A4 inhibitors and treatment cannot be either discontinued or switched to a different medication prior to starting study drug. (http://medicine.iupui.edu/clinpharm/ddis/) ).
* Patients currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug (http://crediblemeds.org/)
* Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection or gastric bypass surgery).
* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
* Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, uncontrolled infection)
* History of another active malignancy within 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively
* Known presence of significant congenital or acquired bleeding disorder unrelated to cancer
* Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered from prior surgery
* Treatment with other investigational agents within 30 days of Day 1.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of female after conception and until the termination of gestation, confirmed by a positive Human chorionic gonadotropin (hCG) laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 14 days after the final dose of nilotinib.
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NCT_ID
NCT02353728
|
Study_NameStem Cell Monitoring for CML Patients Undergoing Nilotinib Therapy
| 20,071 |
Study Objectives
This phase I trial studies the side effects and best dose of alisertib when combined with fractionated stereotactic radiosurgery in treating patients with high-grade gliomas that have returned after previous treatment with radiation therapy (recurrent). Alisertib may stop the growth of tumor cells by blocking an enzyme needed for the cells to divide. Radiation therapy uses high energy x rays to kill tumor cells. Stereotactic radiosurgery uses special positioning equipment to send a single high dose of radiation directly to the tumor and cause less damage to normal tissue. Delivering stereotactic radiosurgery over multiple doses (fractionation) may cause more damage to tumor tissue than normal tissue while maintaining the advantage of its accuracy.
Conditions: Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Adult Oligodendroglioma, Adult Pilocytic Astrocytoma, Adult Pineal Gland Astrocytoma, Adult Subependymal Giant Cell Astrocytoma, Recurrent Adult Brain Tumor
Intervention / Treatment:
RADIATION: Hyperfractionated radiation therapy, RADIATION: Stereotactic radiosurgery, DRUG: Alisertib, PROCEDURE: Quality-of-life assessment
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Patients must have a previously histologically or cytologically confirmed high grade glioma (astrocytic or oligodendroglial supratentorial tumors grade 3 or 4) that has been previously treated with fractionated radiation therapy and now shows evidence of recurrence.
* Patients must have recovered from the toxic effects of prior therapy.
* Patients must have recovered from the effects of surgery. There must be a minimum of 21 days from the day of surgery to the day of protocol treatment. For core or needle biopsy, a minimum of 7 days must have elapsed prior to the day of protocol treatment.
* Prior treatment with cytotoxic and biological agents is permissible. There should be at least a 2-week break between prior treatment and the protocol treatment.
* Prior treatment with fractionated radiation therapy (up to 60Gy) is an eligibility criterion, however there should not have been a second course of fractionated radiotherapy to the supratentorial area.
* One prior single fraction radiosurgical procedure within the treatment field is acceptable if V12<5 cc (V12 is the volume of normal brain (outside GTV) receiving 12 or more Gy). Additional radiosurgical procedures outside of the treatment area are acceptable.
* Subject must be able to take oral medication and to maintain a fast, is required for 2 hours before and 1 hour after MLN8237 administration.
* ANC > 1500/mm³, platelets > 100,000/mm³, Hgb > 9 g/dL. Values must be obtained without need for myeloid growth factor or platelet transfusion support within 14 days of registration. However, erythrocyte growth factor is allowed as per published ASCO guidelines.
* Total bilirubin <= ULN, SGOT (AST) and SGPT (ALT)< 1.5 x ULN, within 14 days of registration.
* Adequate renal function as defined by: calculated creatinine clearance must be >=40 mL/minute (Cockcroft-Gault), within 14 days of registration.
* Age >18 years.
* ECOG performance status <2 (see Appendix I).
* Life expectancy of greater than 2 months.
* Women of childbearing potential must have a negative β-HCG pregnancy test documented within 7 days prior to registration.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease requiring supplemental oxygen.
* Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection.
* Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
* Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
* Patient has received other investigational drugs within 14 days before enrollment
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study.
* Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study.
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion.
* Patients have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated basal or squamous cell carcinoma of skin, superficial bladder cancer or carcinoma in situ of cervix, AJCC (version 7.0) stage 0 or I breast cancer, AJCC (version 7.0) stage I, or II prostate cancer.
* Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is considered to be over 25%.
* Patients who cannot swallow whole tablets (i.e. medication tablets)
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NCT_ID
NCT02186509
|
Study_NameAlisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas
| 18,122 |
Study Objectives
The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer
Conditions: Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated
Intervention / Treatment:
DRUG: Zoledronic acid
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Written informed consent must be obtained
* Age > 18 years
* Histologically confirmed diagnosis of carcinoma of the prostate
* Current (or previous) objective evidence of metastatic disease to the bone
* Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments
* ECOG performance status of 0, 1, or 2
Exclusion Criteria:
* Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less
* Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
* WBC<3.0x1'000'000'000, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x 1'000'000'000/L.
* Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
* Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
* Known hypersensitivity to zoledronic acid or other bisphosphonates
* Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
Other protocol-defined inclusion / exclusion criteria apply.
|
NCT_ID
NCT00172016
|
Study_NameA Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates
| 4,671 |
Study Objectives
There is some evidence that vitamin D could be used to reduce breast cancer risk. Randomized controlled trials would provide definitive evidence about this effect. However, trials with breast cancer as outcome are expensive and time-consuming. Use of surrogate outcomes has been advocated to accelerate progress in the identification of interventions that could prevent breast cancer. Mammographic breast density is one of the strongest breast cancer risk indicators and is already used as a surrogate outcome in several breast cancer prevention trials. The aim of this double-blind randomized controlled trial is to determine whether daily oral supplementation with vitamin D3 (1,000, 2,000 or 3,000 IU) over a period of 1 year reduces breast density in premenopausal women compared to placebo. A total of 376 women (94 per arm) who live in Quebec City will be recruited. Showing that vitamin D reduces breast density would provide strong support for the idea that vitamin D can be a safe and inexpensive approach for the prevention of breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: Vitamin D3, DIETARY_SUPPLEMENT: Placebo
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* be premenopausal at baseline;
* have breast density of at least 20% at baseline;
* have normal baseline serum calcium (2,12 <= age <= 2,60 mmol/L) and serum creatinine (45 <= age <= 85 μmol/L);
* agree to have her mammogram at 12 months of follow-up at the same mammography clinic (same site) as the one where the mammogram at recruitment was done.
Exclusion Criteria:
* taking > 400 IU/day of supplemental vitamin D and refusing to reduce (<= 400 IU/day) or cease such intake;
* taking > 600 mg/day of supplemental calcium and refusing to reduce (<= 600 mg/day) or cease such intake;
* have contra-indications for use of vitamin D supplementation (hypersensitivity to vitamin D or its analogues; a history of renal calculi or hypercalcemia, hypervitaminosis D);
* taking medication suspected to interact with vitamin D: frequent use of antacids containing magnesium or aluminium; regular use of anticonvulsants (phenytoin, phenobarbital), digoxin, cholestyramine, colestipol, orlistat, mineral oil;
* have a personal history of breast cancer;
* have a personal history of cancer other than non-melanoma skin cancer within 5 last years;
* have had breast reduction or augmentation including breast implantation (or planning to undergo such surgery during the trial);
* be pregnant or planning a pregnancy in the next year.
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NCT_ID
NCT01747720
|
Study_NameVitamin D and Mammographic Breast Density
| 1,837 |
Study Objectives
This study aims to evaluate the overall response rate after 4 cycles and the best response to induction therapy with combination of lenalidomide, subcutaneous bortezomib, and dexamethasone (RsqVD) in patients with newly diagnosed multiple myeloma.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: lenalidomide, DRUG: Subcutaneous bortezomib, DRUG: Dexamethasone
Location: Ireland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Participants must have a diagnosis of symptomatic MM, according to International Myeloma Foundation 2003 Diagnostic Criteria:
* Clonal plasma cells > 10% on bone marrow biopsy
* A monoclonal protein (paraprotein) in either serum or urine ( except in the cases of non-secretory myeloma).
If no monoclonal protein is detected (non-secretory disease), then >= 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required.
* Evidence of end-organ damage felt related to the plasma cell disorder related organ or tissue impairment (ROTI), commonly referred to by the acronym 'CRAB':
* Hypercalcaemia: serum calcium (corrected for albumin) > 10.5mg/sL/>2.65mmol/L or upper limit of normal
* Renal insufficiency defined as serum creatinine > 2mg/sL/177μmol/L
* Anaemia: Normochromic, normocytic with a haemoglobin value > 2g/dL below the lower limit of normal or a haemoglobin < 10g/dL
* Bone lesions (lytic lesions, severe osteopenia or pathologic fractures) as shown by CT scan and/or skeletal survey
* Patient has received no prior treatment with any systemic therapy for the treatment of multiple myeloma.
* Prior treatment of hypercalcaemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period)
* Bisphosphonates are permitted
* Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible. Two weeks must have lapsed since last date of radiotherapy, which is recommended to be a limited field. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and 2 weeks have passed since the last date of therapy.
* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
* Age >= 18 years at the time of signing Informed Consent
* Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Lenalidomide Pregnancy Prevention Risk Management Plan. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL 10 to14 days prior to therapy and repeated again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by Lenalidomide Pregnancy Prevention Risk Management Plan) and must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must practice complete abstinence or agree to use a condom during sexual contact with a FCBP even if they have had a successful vasectomy. All study participants must be registered into the mandatory Lenalidomide Pregnancy Prevention Risk Management Plan, and be willing and able to comply with the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.*A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e. has had menses at any time during the preceding 24 consecutive months)
* All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrolment
* Subject has an ECOG performance status of < 2 or Karnofsky performance status of >= 60 (Appendix E).
* Subject must be able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
* Patient has >= Grade 2 peripheral neuropathy on clinical examination within 14 days before enrolment
* Renal insufficiency (serum creatinine levels > 2.5 mg/dL/221μmol/L, calculated creatinine clearance with Cockcroft-Gault formula (see Appendix G) < 45 ml/min)
* Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e. unable to maintain a platelet count 50,000 cells/mm3)
* Subjects with an absolute neutrophil count (ANC) < 1000 cells/mm3. Growth factors may not be used to meet ANC eligibility criteria
* Subjects with a haemoglobin < 8.0 g/dL
* AST (SGOT) and ALT (SGPT) > 2 x ULN, bilirubin levels 1.5 ULN
* Concomitant therapy medications that include corticosteroids (except as indicated in inclusion criteria)
* Myocardial infarction within 6 months prior to enrolment or has New York Heart Association (NYHA) Class III or IV heart failure (Appendix G), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Clinically relevant active infection requiring treatment (antibiotics, antivirals, antifungals)
* Any serious co-morbid condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study.
* Female subject is pregnant or breast-feeding
* Serious psychiatric illness or addiction likely to interfere with participation in this clinical study
* Uncontrolled diabetes mellitus
* Contraindication to any required concomitant drugs or supportive therapies including hypersensitivity to all anticoagulation and antiplatelet options or hypersensitivity to acyclovir or similar anti-viral drug. History of allergic reaction/hypersensitivity attributed to compounds containing boron, mannitol, polysorbate 80 or sodium citrate dehydrate
* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
* Known seropositive for or active HIV infection or active hepatitis B or C viral infection. Patients who are seropositive because of hepatitis B virus vaccine are eligible
* Known intolerance to steroid therapy
* Patient has hypersensitivity to bortezomib, boron, or mannitol
* Diagnosed or treated for another malignancy within 2 years of enrolment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
* Participation in clinical trials with other anti-myeloma investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
* Radiation therapy within 2 weeks before randomization. Enrolment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy.
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NCT_ID
NCT02219178
|
Study_NameStudy of the Efficacy and Safety of RsqVD Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
| 17,953 |
Study Objectives
The purpose of this study is to determine the effect of treatment with guselkumab in participants with familial adenomatous polyposis (FAP) on rectal/pouch polyp burden.
Conditions: Adenomatous Polyposis Coli
Intervention / Treatment:
DRUG: Guselkumab, DRUG: Placebo
Location: Israel, Germany, Poland, United States, Spain, Sweden, Netherlands, Puerto Rico, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Phenotypic familial adenomatous polyposis (FAP) with disease involvement of the colorectum by either genetic or clinical diagnosis: Adenomatous polyposis coli (APC) germline mutation with or without family history, or with greater than (>)100 adenomas in large intestine and a family history of FAP, attenuated FAP is allowed. FAP phenotype post colectomy for polyposis with a family history of FAP may be allowed
* Post-colectomy or subtotal colectomy
* Polyps with a sum of diameters greater than or equal to (>=)10 millimeter (mm) in the rectum or pouch on biopsy at screening
* A woman of childbearing potential must agree not to get pregnant during the study and at least 12 weeks after the last dose of study administration
* A woman must agree not to breast feed or donate eggs (ova, oocytes) during the study and for a period of 12 weeks after the last administration of study drug
Exclusion Criteria:
* Prior use of any biologic therapy targeting interleukin (IL)-12/23, IL-17, or IL-23 receptor
* Use of non-steroidal anti-inflammatory drugs other than aspirin during the study. The use 100 milligram (mg) of aspirin a day or 700 mg of aspirin per week is allowed
* Treatment with other FAP-directed drug therapy (including NSAID [Nonsteroidal anti-inflammatory drug] drugs), unless completes a 4-week washout period prior to randomization
* High grade dysplasia or cancer on biopsy at screening in GI tract (including stomach, duodenum, and colon/rectum/pouch)
* Duodenal, colorectal, or pouch polyp: >2 centimeter (cm) unless excised at the screening evaluation; and 1 to 2 cm with evidence of high-grade dysplasia upon biopsy unless excised
|
NCT_ID
NCT03649971
|
Study_NameA Study of Guselkumab in Participants With Familial Adenomatous Polyposis
| 18,347 |
Study Objectives
This is a randomized, double-blind, vehicle-controlled, parallel group dose response study evaluating the safety and effectiveness of 2 concentrations of NFX-179 Gel in subjects with cutaneous neurofibromas. At Visit 1, the investigator will identify 10 Target cNFs that fulfil the enrollment criteria. The Target cNFs must be located on the subject's face, anterior trunk, or upper extremities. Two Target cNFs must be on the face and 8 must be on the anterior trunk or upper extremities. The study medication will be applied topically QD to the Target cNFs for 182days (26 weeks). During the duration of the study subjects will be evaluated for safety and efficacy.
Conditions: Cutaneous Neurofibroma, Neurofibromatosis 1
Intervention / Treatment:
DRUG: NFX-179 gel, DRUG: Vehicle gel
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
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Inclusion Criteria:
* Subject is at least 18 years
* Subject must provide written informed consent prior to any study procedures
* Subject must have a clinical diagnosis of NF1
* Subject has 10 clinically diagnosed Target cNFs with preferably 2 Target cNFs located on the face and 8 Target cNFs located on the anterior trunk or upper extremities. Alternatively, at least 1 Target cNF is located on the face, in which case 9 Target cNFs must be located on the anterior trunk or upper extremities. Each Target cNF must meet the following criteria:
* Has, in the investigator's opinion, a clinically typical appearance
* Is not within 1 cm of the orbital rim
* Is not covered with hair that might, in the investigator's opinion, interfere with obtaining photographs or impair evaluation of the cNF
* Has a Physician's Tumor Assessment grade >=2
* Is dome shaped
* Is not pedunculated
* Is a discrete cNF surrounded by sufficient non-affected skin that, in the investigator's opinion:
* The dimensions can be measured
* The perimeter can be outlined in the study photographs
* Is not irritated (e.g., bleeding, inflamed)
* Is not in an area subject to repeated trauma (e.g., area that is shaved, on the beltline, under a bra strap, etc.)
* Does not have an active cutaneous infection
* Target cNFs on the face must have the following tumor dimensions:
* Has a length that is >=5mm and <=14mm
* Has a width that is >=5mm and <=14mm
* Has a height that is >=2mm.
* Target cNFs on the anterior trunk or upper extremities must have the following tumor dimensions:
* Has a length that is >=7mm and <=14mm
* Has a width that is >=5mm and <=14mm
* Has a height that is >=2mm.
* Subject agrees to avoid exposure of Target cNFs to excessive sunlight and to use her/his routine sunscreen if excessive exposure cannot be avoided
* Subject agrees NOT to use tanning beds
* Subject is willing to forego treatment of each Target cNF, except protocol specified therapy, during the study
* Female subjects who are women of childbearing potential must have a negative urine pregnancy test result and be willing to use a protocol approved, contraceptive method for the duration of the study
* Subject is willing and able to follow all study instructions and to attend all study visits.
Exclusion Criteria:
* Subject has used any of the following topical therapies within the specified period prior to Visit 1 on or in proximity to any Target cNF that, in the investigator's opinion, impairs evaluation of any the cNFs or which exposes the subject to an unacceptable risk by study participation:
* Corticosteroids; 30 days
* Prescription retinoids (e.g., tazarotene, tretinoin, adapalene); 30 days
* > 5% of an alpha-hydroxy acid (e.g., glycolic acid, lactic acid); 30 days
* Fluorouracil; 30 days
* Imiquimod; 30 days
* LASER, light (e.g., intense pulsed light [IPL], photo-dynamic therapy [PDT]) or other energy-based therapy; 180 days
* MEK inhibitor or BRAF inhibitor; ever.
* The subject has used any of the following systemic medications therapies within the specified period prior to Visit 1:
* Retinoids (e.g., etretinate, isotretinoin); 90 days
* MEK inhibitors; 180 days
* BRAF inhibitors; 180 days
* Subject has a history of hypersensitivity to any of the ingredients in the study medications
* Subject has any known intercurrent illness or physical condition that would, in the investigator's opinion, impair evaluation of a Target cNF or which exposes the subject to an unacceptable risk by study participation
* Subject has, in the investigator's opinion, clinically relevant history of liver disease, including viral hepatitis, current alcohol abuse, or cirrhosis
* Subject has a history of metastatic disease, or active cancer (excluding nonmelanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or Stage 0 chronic lymphocytic lymphoma) within the previous 5 years
* Subject has any condition (e.g., other skin conditions or diseases, metabolic dysfunction, physical examination findings, clinical laboratory findings) or situation (e.g., vacation, scheduled surgery) that would, in the investigator's opinion, impair evaluation of a Target cNF or which exposes the subject to an unacceptable risk by study participation
* Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within the previous 30 days
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NCT_ID
NCT05005845
|
Study_NameNFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)
| 22,448 |
Study Objectives
This phase II trial is studying how well giving GTI-2040 together with capecitabine works in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. GTI-2040 may help capecitabine kill more tumor cells by making them more sensitive to the drug
Conditions: Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
Intervention / Treatment:
BIOLOGICAL: GTI-2040, DRUG: capecitabine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed metastatic adenocarcinoma of the breast
* Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
* Patients must have progressed on at least one but no more than two prior chemotherapy regimens for metastatic disease; patients must not have received prior capecitabine or 5-fluorouracil; patients with hormone-sensitive tumors should have received hormone treatment and any prior number of hormonal agents will be allowed; patients with tumors that overexpress HER-2/neu (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received herceptin, either in the adjuvant or metastatic setting, unless there is a contraindication to herceptin therapy; all prior therapies must have been completed 4 weeks before treatment
* Life expectancy of greater than 3 months
* ECOG performance status =< 2 (Karnofsky >= 50%)
* Leukocytes >= 3,000/μL
* Absolute neutrophil count >= 1,500/μL
* Platelets >= 100,000/μL
* Total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
* Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min
* Patients must have completed radiation treatment > 4 weeks prior to study entry; previously radiated area(s) must not be the only site of disease
* All major surgical procedures must be completed > 4 weeks prior to study entry; placement of vascular access device or tissue biopsy will not be considered major surgery
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
* Patients must agree to the placement of a central venous catheter in order to receive the continuous infusion treatment
Exclusion Criteria:
* Patients with only non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, which include the following:
* bone lesions
* leptomeningeal disease
* ascites
* pleural/pericardial effusion
* inflammatory breast disease
* lymphangitis cutis/pulmonis
* abdominal masses that are not confirmed and followed by imaging techniques
* cystic lesions
* Patients who have had chemotherapy, hormone therapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients may not be receiving any other investigational agents; patients may not have received prior GTI-2040
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to GTI-2040 or to capecitabine or 5-fluorouracil
* Patients requiring anticoagulant therapy; low-dose anticoagulant (warfarin 1 mg per day) for the primary prophylaxis of venous catheter-associated thrombosis is permitted
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study because GTI-2040 and capecitabine have the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GTI-2040 and capecitabine, breastfeeding should be discontinued if the mother is treated
* Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GTI-2040 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
|
NCT_ID
NCT00068588
|
Study_NameGTI-2040 and Capecitabine in Treating Patients With Metastatic Breast Cancer
| 20,899 |
Study Objectives
The purpose of this study is to determine the safety, tolerability, and the highest dose of GC4419 that can be given to patients with squamous cell cancer of the head and neck who are receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419 for the following:
* Effect on the incidence and severity of radiation induced oral mucositis;
* Effect on the response rate of squamous cell cancer of the head and neck who are receiving radiation therapy and chemotherapy;
* Total concentrations of GC4419 that can be achieved in the blood;
* Changes in proteins and genetics associated with oral mucositis;
* Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open the mouth);
* Observe changes in genetic and molecular markers of oral mucositis;
* Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube use, etc.) of study patients;
* Assess the overall quality of life in study patients with oral mucositis.
Conditions: Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
Intervention / Treatment:
DRUG: GC4419
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: SUPPORTIVE_CARE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN), defined as SCC of the oral cavity or oropharynx, that will be treated with standard cisplatin and Intensity-Modulated Radiation Therapy (IMRT)
* Males or females aged >= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status <= 2
* Adequate bone marrow, liver and kidney function
* Negative serum pregnancy test for females of childbearing potential
* Properly obtained written informed consent
Exclusion Criteria:
* Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, salivary glands or unknown primary tumor
* Metastatic disease (Stage IV C)
* Prior chemotherapy for SCCHN and/or radiotherapy to the region of the study cancer or
* Receiving any agent classified as an antioxidant
* History of malignant tumors other than SCCHN within the last 5 years, except non-melanoma skin cancer or curatively excised in situ cervical carcinoma
* Active infectious disease excluding oral candidiasis
* Presence of oral mucositis at study entry
* Chronic immunosuppression
* Known history of HIV or active hepatitis B/C )
* Prior history of hearing impairment
* Use of investigational agent within 30 days of study entry
* Known allergies or intolerance to cisplatin and similar platinum-containing compounds
* Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
|
NCT_ID
NCT01921426
|
Study_NameA Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck
| 49 |
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