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Study Objectives
Breast cancer (BC) is the most common cancer diagnosis among women and the incidence is increasing. Prognosis and treatment are dependent on the expression of estrogen receptors (ER) in the tumor. ER status is determined by immunohistochemistry (IHC) on biopsy tissue. The ER expression can change over time and be heterogeneous.
The IHC score on ER expression is subjective and can lead to intra and inter observer variability. A new computer image analysis software that can give the exact percentage of colored tumor cells on sectional tumor cuts has been developed.
It is also possible to quantify the ER expression non invasive by using the tracer 16α-18F-flour-17β-estradiol (FES) and in vivo positron emission tomography (PET) scans. FES-PET/CT has a high background activity in the liver which complicates the visualization of liver metastases. Theoretically, a new whole body parametric scan method makes it possible to distinguish background activity from uptake in liver metastases.
Malignant tumors often have an increased perfusion, and previous studies have found that tumors with low metabolism relative to blood flow have the longest disease free survival (DFS). To the best of our knowledge, no previous studies have examined the correlation between ER expression and blood flow.
Conditions: Breast Cancer
Intervention / Treatment:
RADIATION: 16α-18F-fluor-17β-estradiol
Location: Denmark
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with known disseminated breast cancer
* Metastatic ER+ HER2- breast cancer with metastases in the liver, at least two separate liver foci visualised on CT
* Diagnostic CT scan done in connection with clinical control
* Treatment with aromatase inhibitors, and potential additional treatment
* Postmenopausal
Exclusion Criteria:
* Treatment with Tamoxifen or Fulvestrant completed within 5 weeks prior to FES-PET/CT
* ER- metastases
* Life expectancy under three months
* Claustrophobia
* Any pain which makes it impossible to lie in the scanner for 90 minutes
|
NCT_ID
NCT04150731
|
Study_Name16α-18F-fluor-17β-estradiol PET/CT for Visualisation of Estrogen Receptor Positive Liver Metastases From Breast Cancer
| 3,436 |
Study Objectives
This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Erlotinib
Location: Portugal
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Locally advanced or metastatic NSCLC with EGFR mutations
* Measurable disease according to RECIST criteria
* Adequate hematological, renal and liver function
Exclusion Criteria:
* Previous chemotherapy or therapy against EGFR for metastatic disease
* Symptomatic cerebral metastases
* Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
* History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
* Concomitant use of coumarins
|
NCT_ID
NCT01260181
|
Study_NameA Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
| 14,565 |
Study Objectives
The primary goal for this trial is to assess the change in PET scans with the administration of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has been established that zoledronate therapy may play a role in delaying and reducing the incidence of skeletal events. Researchers propose to evaluate the change in the uptake value of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU PET scans can successfully demonstrate and detect bony metastatic sites in prostate cancer.
In addition, investigators would like to evaluate the change in the level of the prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: zoledronate therapy, DEVICE: PET Scan
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histological diagnosis of prostate cancer
* Evidence of metastatic disease by radiologic criteria
* Bone scan within 4 weeks of starting therapy
* Creatinine within 2 weeks of registration, calculated creatinine clearance > 60ml/min.
* Minimum life expectancy of 6 months
* Willingness to have pre-therapy PET scans performed within 2 weeks after registration and post therapy PET scan performed within 1 week after dose of Zometa (a total of 3 PET scans required)
* Calculated creatinine clearance > 50ml/min.
* No prior Zoledronate therapy
* Patients must have disease progression despite testosterone suppression (level<50ng/ml); progression can be by rising PSA ( at least 2 values at least 2 weeks apart) or by new lesions on scans or progression of existing lesions on CT scan.
* No concomitant systemic therapy for metastatic prostate cancer is allowed except LHRH analogue should be continued if necessary to maintain testosterone suppression.
* No concomitant radiation therapy
* Prior RT is allowed if completed at least 2 weeks prior to registration.
* Presence of measurable or evaluable disease
* If RT has been administered, disease outside the RT port is required.
* Willingness to sign informed consent.
* Registration and willingness to sign informed consent for separate PET protocol 2335 that describes the PET scan procedure.
* Patients must have good oral hygiene which includes having a recent dental evaluation
Exclusion Criteria:
* Patients who are unable to swallow
* Patients with dental cavities that are likely to need dental extraction or root canal treatment as management
|
NCT_ID
NCT01205646
|
Study_NamePET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
| 14,373 |
Study Objectives
The purpose of this study is to determine the role of cetuximab (Erbitux) with chemotherapy for advanced colorectal carcinoma. This study will determine if this new agent can improve one's response to standard treatment.
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
DRUG: Cetuximab
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:
* Histologically or cytologically documented stage IIIB or IV NSCLC
* Measurable disease
* ECOG performance status of 0 <= age <= 1
* Asymptomatic brain metastasis; must have completed radiotherapy/radiosurgery at least 2 weeks prior to enrollment and be off steroids.
* Radiotherapy must have been completed > 2 weeks prior to enrollment and patients must have recovered from adverse events of radiotherapy.
* >= 18 years
* Adequate hematologic function: absolute neutrophil count (ANC) >= 1,500/mm3; platelets >= 100,000/mm3.
* Adequate hepatic function: total bilirubin <= 1.5 X upper limit of normal (ULN); AST and ALT <= 2.5 X ULN.
* Adequate renal function: serum creatinine <= 1.5mg/dL or creatinine clearance >= 50cc/minute if serum creatinine > 1.5
* Signed an approved informed consent for this protocol and an approved informed consent for Health Insurance Portability and Accountability Act (HIPAA)
* EGFR status by immunohistochemistry (IHC) if sufficient tissue is available
Exclusion Criteria:
* Women of childbearing potential who have a positive pregnancy test at enrollment or within 7 days of treatment. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth regulation/control. Note: Patients are considered to not be of childbearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
* Patients who have had prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years.
* Patients with significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, myocardial infarction within the past year, cardiomyopathy with decreased ejection fraction, or cardiac ventricular arrythmias within the last year requiring new treatment .
* Patients with an uncontrolled seizure disorder, or active neurological disease.
* Patients with symptomatic brain metastasis.
* Patients who have received prior systemic chemotherapy.
* Patients who have received prior cetuximab or other therapy which specifically and directly targets the EGF pathway.
* Prior infusion reaction to a monoclonal antibody or prior hypersensitivity to Cremophor EL.
* Patients with known peripheral neuropathy (> grade 1).
|
NCT_ID
NCT00315185
|
Study_NameStudy of Paclitaxel, Carboplatin, and Cetuximab for Advanced Lung Cancer
| 18,077 |
Study Objectives
The goal of this clinical research study is to determine the safety and effects of giving a special kind of immune cells called "alloreactive natural killer (NK) cells" with high dose chemotherapy and allogeneic hematopoeitic stem cell transplantation with the goal of defining the maximum tolerated dose of NK cells. The NK cells will be donated from a relative of yours who has certain genetic type in their blood called HLA, that almost matches yours. The stem cells you will receive will come from a separate HLA matched (HLA A, B, C, DR) relative or unrelated donor. The safety of this treatment will also be studied.
Conditions: Myelodysplastic Syndrome, Leukemia
Intervention / Treatment:
DRUG: Thymoglobulin, DRUG: Busulfan, DRUG: Fludarabine, PROCEDURE: Alloreactive NK Infusion, DRUG: G-CSF, DRUG: Tacrolimus, DRUG: Methotrexate, DRUG: Interleukin-2
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 age <= 70 years with one of of the following: Acute myeloid leukemia past first remission, in first or subsequent relapse, in second or greater remission or primary induction failure; Myelodysplastic syndromes with intermediate or high risk IPSS score; CML which has progressed to accelerated phase or blast crisis despite imatinib treatment
* Patients must have an HLA matched (HLA A, B, C, DR) related or unrelated donor willing to donate for allogeneic peripheral blood progenitor cell transplantation. (Recent large analyses of the National Marrow Donor Program indicate that a mis-match at the DQ locus has no adverse effect on outcome. The current national standard of care is to consider only these 4 loci in identifying suitably "matched" donors.)
* Patients must have a haploidentical relative who is predicted to be alloreactive based upon the presence of the relevant KIR genes and incompatibility with the recipient for HLA C and Bw antigens.
* Zubrod performance status <= 2.
* Left ventricular ejection fraction >= 45%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
* No symptomatic pulmonary disease. forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) >= 50% of expected, corrected for hemoglobin.
* Serum creatinine <= 1.8mg%.
* Serum glutamate pyruvate transaminase (SGPT) <= 200 IU/ml unless related to patients malignancy.
* Bilirubin <= 1.5 mg/dl (unless Gilbert's syndrome).No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
* Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
* No known allergy to mouse proteins or monoclonal antibodies
Exclusion Criteria:
* Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
* Pleural/pericardial effusion or ascites estimated to be >1L.
* HIV-positive.
* Pregnancy: Positive Beta Human Chorionic Gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
* Known allergy to mouse proteins.
* Patient has received other systemic chemotherapeutic drugs (including Mylotarg) within 14 days prior to trial enrollment or has unresolved grade >1 toxicity from prior chemotherapy treatment. (Hydroxyurea or low dose ara-c less than or equal to 20 mg/m2/d is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed lumbar microdiscectomy (LMD), that is in remission prior to enrollment on this study).
|
NCT_ID
NCT00402558
|
Study_NameAlloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
| 6,893 |
Study Objectives
This study is being done to examine the effect of Parenteral (intravenous) nutrition support in the home setting on quality of life in cancer patients. In addition, this study is being done to examine the effect of home parenteral nutrition on the use of pain and anti-nausea medication.
Conditions: Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: Home Parenteral Nutrition
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Patients with a cancer diagnosis who have been receiving parenteral nutrition in the hospital or have started on HPN while at Cancer Treatment Centers of America and meet the criteria for home parenteral nutrition.
* Patient expected to have a life expectancy of greater than 90 days post discharge.
Exclusion Criteria:
* Patients less than 18 years
* HPN patients who do not receive nutrition assessment and follow-up by the Coram Healthcare nutrition support team
* Refuse to participate
|
NCT_ID
NCT01152879
|
Study_NameHome Parenteral Nutrition in Cancer Patients
| 17,429 |
Study Objectives
This phase II trial is studying how well SB-715992 works in treating patients with recurrent or metastatic head and neck cancer. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.
Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland 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 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, 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 Oropharynx, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Intervention / Treatment:
DRUG: ispinesib, OTHER: laboratory biomarker analysis, OTHER: pharmacological study
Location: Canada
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 squamous cell carcinoma of the head and neck that is recurrent or metastatic; with the exception of the nasopharynx, all primary sites (including oral cavity, oropharynx, hypopharynx, and larynx) will be eligible; MedDRA disease terms:
* Oral neoplasms NOS, 10031008
* Oropharyngeal cancer recurrent, 10031098
* Hypopharyngeal cancer recurrent, 10021044
* Laryngeal cancer recurrent, 10023828
* Maxillofacial sinus neoplasm, 10026956
* Head and neck, 90002024
* Patients may have had a maximum of one prior chemotherapy regimen for recurrent or metastatic disease; patients may enter this study and receive SB-715992 as their first-line therapy for recurrent and/or metastatic disease; prior platinum-based chemotherapy delivered concurrently with radiotherapy, or prior platinum-based induction chemotherapy, is allowed; there must be at least a 4 week interval between any chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy or surgery and study enrollment; exceptions may be made however, for low dose, non-myelosuppressive radiotherapy - please contact the Principal Investigator (Dr. E. Winquist) PRIOR to registration if questions arise about the interpretation of this criterion; for patients who received local therapy prior to study entry, there must be either progression of measurable disease documented within the treatment field, or must have measurable disease outside the treatment field prior to study entry
* 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 >= 10 mm with spiral CT scan
* Life expectancy of greater than 12 weeks.
* ECOG performance status 0,1, or 2
* Leukocytes >= 3,000/uL
* Absolute neutrophil count >= 1,500/uL
* Platelets >= 100,000/uL
* Total bilirubin =< 1.5 X institutional upper limit of normal
* AST(SGOT)/ALT(SGPT) =< 3.0 X institutional upper limit of normal (=< 5.0 X if liver metastases)
* Creatinine =< 1.5 X institutional upper limit of normal
* Peripheral neuropathy may be no greater than grade 1
* Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of SB-715992 will be determined following review of their use by the TREATING RESPONSIBLE investigator; patients receiving nonprohibited medications or substances known to interact with CYP450 isoenzymes may be eligible but should be monitored carefully; questions about eligibility related to concommitant use of medications should be discussed with the Principal Investigator
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
* Patients requiring oral anticoagulants (coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring INR. If medically appropriate and treatment available, the investigator may also consider switching these patients to LMW heparin, where an interaction with SB-715992 is not expected
* 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
Exclusion Criteria:
* Patients with non-squamous cell carcinomas of the head and neck or nasopharyngeal cancer
* 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 AEs due to agents administered more than 4 weeks earlier
* Patients may not have received any other investigational agents within 28 days of study entry
* Patients may not receive other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study
* The following lists of medications/substances are moderate to significant inhibitors/inducers of CYP3A4 that, if administered concomitantly with SB-715992, may alter study drug exposure; the use of these medications/substances within 14 days (>= 6 months for amiodarone) prior to the administration of the first dose of SB-715992 through discontinuation from the study is prohibited
* Inhibitors of CYP3A4:
* Antibiotics: clarithromycin, erythromycin, troleandomycin
* Antifungals: itraconazole, ketoconazole, fluconazole (doses > 200 mg/day), voriconazole
* Antidepressants: nefazodone, fluovoxamine
* Calcium channel blockers: verapamil, diltiazem
* Miscellaneous: amiodarone*, grapefruit juice, bitter orange
* Use of amiodarone within 6 months prior to the administration of the first dose of SB-715992 is prohibited
* Inducers of CYP3A4:
* Anticonvulsants: phenytoin, carbamazepine, Phenobarbital, oxcarbazepine
* Antibiotics: rifampin, rifabutin, rifapentine
* Miscellaneous: St. John's wort, modafinil
* 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 SB-715992
* 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 SB-715992 is a mitotic 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 SB-715992, breastfeeding should be discontinued if the mother is treated with SB-715992
|
NCT_ID
NCT00095628
|
Study_NameSB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
| 19,830 |
Study Objectives
The purpose of this study is to analyse clinical data of well-differentiated grade 3 digestive neuroendocrine tumors. These rare tumors may have a different disease evolution, response to chemotherapy and prognostic.
Conditions: Neuroendocrine Tumors
Intervention / Treatment:
DRUG: platinum chemotherapy
Location: France
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Well-differentiated grade 3 neuroendocrine digestive tumors
* Patient of 18 years and more
Exclusion Criteria:
* Patient opposed to data collection as part of the study
* Digestive neuroendocrine tumors Grade 1 <= age <= 2
* Grade 3 poorly differentiated digestive neuroendocrine tumors
* Malignant disease diagnosed in the last 5 years (except basal cell of the skin and in situ cervical carcinoma)
* Other non-digestive neuroendocrine tumors
* Mixed neuroendocrine non neuroendocrine neoplasm
|
NCT_ID
NCT04365023
|
Study_NameCohort of Well-differentiated Grade 3 Neuroendocrine Digestive Tumors
| 12,757 |
Study Objectives
This is a Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological effects of PRMT5 inhibitor, GSK3326595, in Early Stage Breast Cancer
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: GSK3326595
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Female patients with newly diagnosed histologically confirmed primary invasive breast cancer currently not undergoing any treatment while awaiting surgery
* Operable breast cancer as assessed by treating surgical oncologist
* Tumor >= 1.0 cm by palpation or imaging
* ER or PR positive (>=1%) breast adenocarcinoma
* Her2 negative as per ASCO 2018 guidelines 61
* Invasive ductal or lobular carcinoma, invasive carcinoma Not Otherwise Specified (NOS)
* ECOG PS 0 <= age <= 2 (Appendix A)
* Post-menopausal and not of child bearing potential as defined as: by having 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40mlU/ml and estradiol < 20 pg/mL or have had documented surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior.
* Able to provide written informed consent for the study.
* Able to swallow and retain orally administered medication.
Exclusion Criteria:
* Locally Advanced or metastatic breast cancer
* Prior therapy with chemotherapy or planned neoadjuvant chemotherapy
* Prior hormonal therapy including tamoxifen, aromatase inhibitors
* Pre-dominant histology other than invasive ductal or lobular carcinoma
* Concomitant other invasive malignancy.
* Hgb < 100 g/L, Platelets < 100 x 10^9 per liter, Absolute Neutrophil Count < 1.5 x 10^9/L
* Bilirubin >= 1.5 times Upper Limit Normal (ULN)
* ALT >= 2.5 times ULN
* Albumin < 25 g/L
* INR/PTT > 1.5 times ULN
* Creatinine clearance calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of less than 50 mL/min/1.73m2.
* Cardiac abnormalities as evidenced by any of the following:
1. Baseline QTcF interval >= 480 msec
2. Clinically significant conduction abnormalities or arrhythmias
3. Presence of cardiac pacemaker or defibrillator with a paced ventricular rhythm limiting ECG analysis.
4. History or evidence of current >= Class II congestive heart failure as defined by New York Heart Association (NYHA).
5. History of acute coronary syndromes (including unstable angina and myocardial infarction), coronary angioplasty, or stenting within the past 3 months.
6. Clinically significant cardiomegaly, ventricular hypertrophy, or cardiomyopathy.
* Any serious known immediate or delayed hypersensitivity reaction(s) to GSK3326595, or idiosyncrasy to drugs chemically related to the investigational drugs.
* Current use of a prohibited medication or planned use of any forbidden medications during treatment with GSK3326595, which include chemotherapy, immunotherapy, biologic therapy, investigational therapy, or hormonal therapy (other than corticosteroids) while on treatment in this study. GSK3326595 should not be co-administered with potent inhibitors of either BCRP or Pgp such inhibitors include cyclosporine, tacrolimus, and ketoconazole
* Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption, such as malabsorption syndrome, chronic gastrointestinal disease, or major resection of the stomach and/or bowels that could preclude adequate absorption of the study medication.
* Severe, uncontrolled systemic disease (respiratory, cardiac, renal, hepatic, bleeding)
* Currently active liver or biliary disease
* History of active HIV, Hepatitis B or C infection.
* Any other criteria which, in the investigator's opinion, renders the patient ineligible to be on study.
* Subjects with signs/symptoms suggestive of COVID-19 or known COVID-19 positive contacts in the past 14 days would be tested as per local Public Health and/or Institutional Guidelines. If patients are COVID-19 positive at the time of screening, they would be excluded from the trial.
|
NCT_ID
NCT04676516
|
Study_NameA Phase II Window of Opportunity Trial of PRMT5 Inhibitor, GSK3326595, in Early Stage Breast Cancer
| 8,050 |
Study Objectives
Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered surgery. There are different types of procedures and most of them are complex with a risk for complications. The researchers want to start a pilot study on 10 patients with a new surgical technique using neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an important role in facial pain. There have been a few trials trying to block this structure in trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers technique requires local anesthesia only (awake patient). The researchers believe that this treatment can become a "low threshold"-treatment for patients who do not have enough effect with pharmacological treatment and a better alternative to other complex surgical approaches. Using this new neuronavigation system the researchers can reach this neural structure with high precision.
Conditions: Trigeminal Neuralgia, Headache Disorders
Intervention / Treatment:
DRUG: Botulinum Toxin Type A
Location: Norway
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Informed and written consent
* Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria
* Unsatisfactory effect of pharmacological treatment
Exclusion Criteria:
* Microvascular decompression is seen as a better alternative
* Heart or lung disease
* Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
* Psychiatric illness that hinders participation in the study
* Known pregnancy or breast feeding
* Inadequate use of contraceptives
* Overuse or abuse of opioids
* Abuse of medications, narcotics or alcohol
* Anomalies which hinder or impede the used method of injection
* Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication
* Treatment with medication that can interact with botulinum toxin type A
|
NCT_ID
NCT02662972
|
Study_NameBotulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
| 9,146 |
Study Objectives
The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.
Conditions: Biliary Tract Cancer (BTC), Colorectal Cancer (CRC), Endometrial Cancer, Gastroesophageal Cancer (GC), Ovarian Cancer, Solid Tumors
Intervention / Treatment:
DRUG: INCB001158, DRUG: Oxaliplatin, DRUG: Leucovorin, DRUG: 5-Fluorouracil, DRUG: Gemcitabine, DRUG: Cisplatin, DRUG: Paclitaxel
Location: Belgium, United Kingdom, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
* Presence of measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.
* Resolution of treatment-related toxicities.
* Adequate hepatic, renal, cardiac, and hematologic function.
* Additional cohort-specific criteria may apply.
Exclusion Criteria:
* Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
* Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
* Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
* Has received prior approved radiotherapy within 14 days of study therapy.
* Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Has an active infection requiring systemic therapy.
* Has known active CNS metastases and/or carcinomatous meningitis.
* Women who are pregnant or breastfeeding.
|
NCT_ID
NCT03314935
|
Study_NameA Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
| 4,555 |
Study Objectives
This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil 0.5% cream against the brand product (Carac) in participants with actinic keratoses.
Conditions: Actinic Keratosis
Intervention / Treatment:
DRUG: Generic Fluorouracil Cream, DRUG: Carac® (Fluorouracil) Cream, DRUG: Vehicle Cream
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
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Inclusion Criteria:
* Participant is male and/or female, 18 years or older.
* Participant is willing and able to give written informed consent.
* Participant is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
* Participant has a clinical diagnosis of actinic keratoses with at least 5 and no more than 10 clinically typical, visible or palpable, discrete, actinic keratoses (AK) lesions, each at least 4 millimeters (mm) in diameter on the face (excluding ears) or balding scalp.
* Participant is in good general health and free of any disease state or physical condition that might impair evaluation of AK lesions or which, in the investigator's opinion, exposes the participant to an unacceptable risk by study participation.
* Females must be post-menopausal, surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit.
Exclusion Criteria:
* Participant is pregnant, lactating, or is planning to become pregnant during the study.
* Participant is currently enrolled in an investigational drug or device study.
* Participant has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.
* Participant has hyperkeratotic, hypertrophic, or large mat-like AK lesions (for example, an AK lesion >1 cm^2 in size) within the treatment area.
* Participant has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study.
* Participant is immunosuppressed (for example, human immunodeficiency virus (HIV), systemic malignancy, graft host disease)
* Participant has experienced an unsuccessful outcome from previous topical fluorouracil therapy (an unsuccessful outcome is defined as after a reasonable therapeutic study with no compliance issues and the topical drug did not work).
* Participant has a history of sensitivity to any of the ingredients in the test articles.
* Participant has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
* Participant used topical creams, lotions, or gels of any kind within the selected treatment area within 1 day prior to entry into the study.
* Participant has used topical medications; corticosteroids, alpha hydroxy acids (for example, glycolic acid, lactic acid, etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate; or prescription retinoids (for example, tazarotene, adapalene, tretinoin) within the selected treatment area (face or balding scalp) within 1 month prior to the Baseline Visit.
* Participant has had cryodestruction, curettage, photodynamic therapy, surgical excision, or other treatments for AK within the selected treatment area (face or balding scalp) within 1 month prior to the Baseline Visit.
* Participant has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies, or retinoids within 1 month prior to the Baseline Visit.
* Participant has had dermatologic procedures or surgeries such as: laser resurfacing, Psoralen + ultraviolet A (PUVA) therapy, ultraviolet B therapy, chemical peels, or dermabrasion within the selected treatment area (face or balding scalp) within 6 months prior to the Baseline Visit.
* Participant has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or balding scalp).
* Participant has any skin pathology or condition on the face or balding scalp that, in the Investigator's opinion, could interfere with the evaluation of the test article or requires the use of interfering topical, systemic, or surgical therapy.
* Participant has any condition which, in the Investigator's opinion, would make it unsafe or preclude the participant's ability to fully participate in this research study.
* Participant is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, impaired cerebral function, or physical limitations.
* Participant is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (for example, due to alcoholism, drug dependency, mental incapacity) in the opinion of the Investigator.
* Participant has been previously enrolled in the same study.
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NCT_ID
NCT02616601
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Study_NameMulticenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis
| 11,296 |
Study Objectives
The main purpose of this study is to evaluate the safety of different doses of olaratumab and to determine which dose should be used for future pediatric studies. The present study is open to children with advanced cancer or cancer that has spread to another part of the body. The study has three parts. In the first two parts, a specific dose of olaratumab will be given in 21 day cycles, followed by one of three standard chemotherapy regimens. In the third part, a specific dose of olaratumab will be given with one of three standard chemotherapy regimens in 21 day cycles. Participants will only enroll in one part.
Conditions: Neoplasm Metastasis
Intervention / Treatment:
DRUG: Olaratumab, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Irinotecan, DRUG: Ifosfamide
Location: Japan, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* The participant must have histological or cytological evidence of a diagnosis of solid tumor, excluding lymphomas and melanoma, but including central nervous system (CNS) tumors, that is relapsed or refractory, not be amenable to curative treatment.
* The participant has the presence of measurable and/or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST Version 1.1). Response Assessment in Neuro-Oncology (RANO) Criteria or Macdonald Criteria should be used for CNS tumors.
* The participant has a Lansky (<16 years) or Karnofsky (>=16 years) performance score of at least 50.
* The participant has adequate hematologic, organ, and coagulation function <=2 weeks (14 days) prior to first dose of study drug:
* Absolute neutrophil count (ANC) >=750 cubic millimeters (mm³)
* Platelets >=75,000/mm³
* Hemoglobin >=8 grams per deciliter (g/dL)
* Total bilirubin (sum of conjugated + unconjugated) <=1.5 x upper limit of normal (ULN) for age
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3.0 x ULN
* Serum creatinine is based on age/gender
* Adequate coagulation function as defined by International Normalized Ratio <=1.5 or prothrombin time <=1.5 x ULN, and partial thromboplastin time <=1.5 x ULN
* Both female and male participants of child-bearing potential must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of olaratumab, or longer for other study drugs according to their label.
* Participants must have fully recovered from the acute toxic effects of all prior anticancer therapies or must adhere to post-treatment conditions as follows:
* Myelosuppressive chemotherapy
* Hematopoietic growth factors
* Biologic (anti-neoplastic agent)
* Antibody therapy
* Radiation
* Stem cell infusion without traumatic brain injury
* Corticosteroids
Exclusion Criteria:
* Have received treatment within 21 days of the initial dose of olaratumab with an investigational product or non-approved use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Participants that have had bone marrow or solid organ transplant are excluded.
* The participant has an active fungal, bacterial, and/or known severe viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
* Female participants who are pregnant or breastfeeding are excluded.
* If the participant is to be enrolled in the doxorubicin combination arm, a left ventricular dysfunction (LVEF < 50%) or shortening fraction of <27% by echocardiogram (either multigated acquisition [MUGA] or echocardiogram [ECHO] are required, not both).
* Participants that have received prior anthracycline therapy if the participant is to be enrolled in the doxorubicin combination arm.
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NCT_ID
NCT02677116
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Study_NameA Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer
| 4,735 |
Study Objectives
This phase I trial studies the side effects and best dose of tivantinib when given in combination with temsirolimus in treating patients with solid tumors that have spread to other parts of the body or cannot be removed by surgery. Tivantinib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions: Adult Solid Neoplasm
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, DRUG: Temsirolimus, DRUG: Tivantinib
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 confirmed solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which standard curative or palliative systemic therapies (such as chemotherapy, targeted therapies or immunotherapy) do not exist or are no longer effective
* Patients must have measurable or evaluable disease, as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
* No prior treatment with temsirolimus or an agent specifically targeting met proto-oncogene (c-Met)
* Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
* Life expectancy of greater than 12 weeks
* Hemoglobin >= 9.0 g/dL
* Leukocytes >= 3,000/mcL
* Absolute neutrophil count >= 1,500/mcL
* Platelets >= 100,000/mcL
* Total bilirubin =< 1.5 X institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< institutional upper limit of normal
* Serum creatinine =< institutional upper limit of normal or creatinine clearance (either estimated or calculated) >= 60 mL/min/1.73 m for patients with creatinine levels above institutional normal
* Fasting glucose =< 150 mg/dL
* Fasting cholesterol level < 350 mg/dl
* Fasting triglycerides =< 300 mg/dl
* Phosphorus >= institutional lower limit of normal (repletion allowed)
* Patients with treated, stable brain metastases are allowed to enroll; patients must be at least 4 weeks from radiation and off any medications used to treat brain metastases including steroids; patients are allowed to be on antiepileptic medications that are not metabolized by cytochrome P450 3A4 or 2C19; patients with brain metastases must have stable brain imaging within 4 weeks prior to starting study
* Women of child-bearing potential 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 up to 3 months after discontinuation of study drugs; 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 ARQ 197 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
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Any of the following:
* Chemotherapy =< 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C)
* Radiotherapy, endocrine therapy or targeted therapy for malignancy =< 2 weeks prior to registration
* Patients who have not recovered (=< grade 1) from adverse events due to agents administered more than 4 weeks earlier (tolerable grade 2 adverse events may be allowed at the discretion of the investigator; diarrhea must be grade 1 or lower without the scheduled use of antidiarrheal medications)
* Prior anticancer therapy with an mammalian target of rapamycin (mTOR) inhibitor (everolimus, temsirolimus, desferolimus) or agent specifically targeting c-Met
* Patients who are receiving any other investigational agents
* Patients may not have clinically symptomatic hypothyroidism; testing is not required for eligibility
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ARQ 197 or temsirolimus
* ARQ 197 is a sensitive substrate for 2C19 and 3A4, a strong inhibitor for 2C19 and moderate inhibitor by in vitro data only for 3A4; temsirolimus is a sensitive substrate for CYP 3A4 and a weak inhibitor of CYP2D6 and CYP3A4/5; per the UWinRx Drug Interaction Policy, the following medications are contraindicated or must be used with caution
* Contraindicated:
* CYP2C19 sensitive substrates (unless close monitoring with labs or drug levels with dose adjustments is feasible), inducers, and moderate/strong inhibitors of CYP2C19; patients taking these concurrent medications are ineligible unless they can be switched to alternative medications prior to initiation of the study
* CYP3A4/5 inducers and moderate/strong inhibitors of CYP3A4/5; patients taking these concurrent medications are ineligible unless they can be switched to alternative medications prior to initiation of the study
* Use with caution:
* CYP2C19 non-sensitive substrates with a narrow therapeutic window and weak inhibitors are permitted if no acceptable alternatives are available as determined by the treating physician; however, caution should be used; consider monitoring with labs or drug levels and dose adjustments of the medication if feasible; other non-sensitive substrates are allowed on study
* CYP3A4/5 sensitive substrates and any non-sensitive substrates with a narrow therapeutic window and weak inhibitors are permitted if no acceptable alternatives are available as determined by the treating physician; however, caution should be used; consider monitoring with labs or drug levels and dose adjustments of the medication if feasible; other non-sensitive substrates are allowed on study
* CYP2D6 inducers, moderate/strong inhibitors or sensitive substrates are permitted if no acceptable alternatives are available; however, caution should be used; other non-sensitive substrates or weak inhibitors of CYP2D6 are allowed on study
* History of congestive heart failure defined as class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); clinically significant bradycardia (< 50 beats per minute [bpm]) or other uncontrolled, cardiac arrhythmia defined as >= grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension (as determined by the investigator); myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring > 6 months prior to study entry is permitted)
* Patients with uncontrolled diabetes (as determined by the investigator); well-controlled diabetic patients with fasting glucose < 150 are eligible if they have been on stable doses of medications for diabetes for at least 4 weeks prior to study entry
* 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; breastfeeding should be discontinued if the mother is treated on this study
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
* Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption of pills; patients must be able to swallow pills
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NCT_ID
NCT01625156
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Study_NameTivantinib and Temsirolimus in Treating Patients With Solid Tumors That is Metastatic or Cannot be Removed by Surgery
| 20,880 |
Study Objectives
The study is a first in man, dose escalation study to evaluate the safety, tolerability and how the drug works in the body in patients with all solid tumours. The aim of this study is to determine the most effective dose of the study drug that can then be further investigated in patients with advanced melanoma.
Conditions: Melanoma, Cancer
Intervention / Treatment:
DRUG: CCT3833
Location: United Kingdom
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:
* 18 years or over.
* Written (signed and dated) informed consent and willing and capable of co-operating with study procedures, treatment and follow-up.
* Histologically proven advanced or metastatic solid tumours.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 12 weeks.
* Haematological and biochemical indices (within 7 days before the first dose of CCT3833) within the ranges shown below:
1. Haemoglobin (Hb) >= 9.0 g/dL.
2. Absolute neutrophil count >= 1.5 x 109/L.
3. Platelet count >= 100 x 109/L.
4. Total bilirubin <= 1.5 x upper limit of normal (ULN), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x (ULN) (or <= 5 x ULN if elevated due to tumour).
5. Calculated creatinine clearance > 50 mL/min (based on Cockcroft-Gault calculation).
* Negative pregnancy test for females of child-bearing age.
Inclusion criteria: dose expansion cohort
Patients must meet ALL of the above criteria and additionally meet the following criteria:
* Histologically proven locally advanced (unresectable) or metastatic melanoma.
* Documented presence of either BRAF or RAS mutations, as established by validated mutation testing from tumour biopsy.
* Evidence of measurable disease (according to RECIST v1.1)
Exclusion Criteria:
Patients who meet ANY of the following criteria will not be eligible to participate.
Patients who have had any of the following within the last 4 weeks:
* Radiotherapy (except for palliative reasons), endocrine therapy (except luteinizing hormone releasing hormone (LHRH) agonists for prostate cancer), immunotherapy or chemotherapy (6 weeks for nitrosoureas, Mitomycin-C and 4 weeks for other investigational medicinal products (IMP)) before treatment. (For patients recruited to Part B (dose expansion) from Part A (dose escalation), prior treatment with CCT3833 during Part A (dose escalation) is permissible.)
* Major surgery within the last four weeks.
* Has been a participant in another interventional research study (involving an IMP) within the last 4 weeks, or plans to participate in one whilst taking part in this study. Participation in an observational study would be acceptable.
Patients who have any of the following:
* High medical risk because of non-malignant systemic disease including active, uncontrolled infection.
* Known allergy to any pharmaceutical excipients.
* Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV). Testing for these viruses is not mandatory.
* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
1. History or presence of ventricular tachyarrhythmia.
2. Presence of unstable atrial fibrillation (ventricular response > 100 bpm); patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria.
3. Repeated presence of a prolonged QTc interval > 450 ms at baseline (as calculated by Fridericia method).
4. Unstable angina pectoris or acute myocardial infarction in the last 12 months prior to starting study drug.
5. Other clinically significant heart disease (e.g., symptomatic congestive heart failure (LVEF < 50%); uncontrolled arrhythmia; history of labile hypertension or poor compliance with an antihypertensive regimen).
* Uncontrolled hypertension that remains uncontrolled on > 1 antihypertensive agent.
* Symptomatic brain metastases (if present they must have been stable for > 3 months). Such patients must not be requiring systemic corticosteroid or enzyme-inducing anticonvulsant therapy.
* Inability to take oral medication; impairment of GI function or GI disease that could interfere with drug absorption.
* Have taken potent inducers/inhibitors of CYP3A4 and CYP2C8 liver enzymes within 2 weeks of the first administration of study drug, or have conditions that require the concomitant usage of such drugs during the course of the study.
* Are taking warfarin as an oral anticoagulant; patients anticoagulated with low molecular weight heparin are not excluded from the trial.
* Female patients who are pregnant or lactating, or have the ability to become pregnant. However, those female patients who have a negative serum or urine pregnancy test before enrolment and are using highly-effective contraception during the study and for 6 months afterwards, are considered eligible. Highly-effective contraception methods include:
1. Total abstinence.
2. Male or female sterilization.
3. A combination of any two of the following:
i. Oral, injected or implanted hormonal contraception. ii. Placement of an intrauterine device (IUD) or intrauterine system (IUS). iii. Barrier methods of contraception: condom or diaphragm with spermicidal foam/gel/film/cream/vaginal suppository.
* Male patients with partners of child-bearing potential, unless they agree to take measures not to father children by using one form of highly effective contraception as defined above, during the study and for 6 months afterwards. Men with pregnant or lactating partners should be advised to use barrier method contraception to prevent exposure to the foetus or neonate.
* Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical study.
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NCT_ID
NCT02437227
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Study_NameA Phase I, First in Man Study to Evaluate the Safety and Tolerability of a panRAF Inhibitor (CCT3833/BAL3833)in Patients With Solid Tumours
| 1,218 |
Study Objectives
This is a study looking at a new way to evaluate vascular problems or tumors in brain surgery patients using a standard \& approved intravenous dye and augmented reality.
Conditions: Vascular; Lesion, Central Nervous System, Brain Tumor, Cerebral Aneurysm, Cerebral AVM
Intervention / Treatment:
DEVICE: GLOW800, DRUG: indocyanine green (ICG)
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
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Inclusion Criteria:
* adult patients with a brain lesion requiring surgery and for whom ICG videoangiography would be used
Exclusion Criteria:
* allergy to ICG (indocyanine green)
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NCT_ID
NCT03888014
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Study_NameIntraoperative Fluorescence With Augmented Reality
| 13,446 |
Study Objectives
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.
Conditions: Ovarian Neoplasms, Ovarian Cancer
Intervention / Treatment:
DRUG: Niraparib
Location: Canada, 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 agree to undergo tumor HRD testing and blood gBRCAmut status testing.
* Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
* Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy.
* Patients Must have completed 3 or 4 previous chemotherapy regimens.
* Patients must have completed their last chemotherapy regimen > 4 weeks prior to treatment initiation.
* Patients must have measurable disease according to RECIST (v.1.1).
* Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
* Patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis.
Exclusion Criteria:
* Patients must not have any known, persistent (> 4 weeks), >=Grade 3 hematologic toxicity during the last cancer therapy. Patients must not have any known, persistent (>4 weeks), >= Grade 3 fatigue during the last cancer therapy.
* Patients must not have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
* Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.
* Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
* Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
* Patients must not have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
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NCT_ID
NCT02354586
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Study_NameA Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
| 3,987 |
Study Objectives
This is a multi-centre Phase III randomized controlled study of patients with multiple myeloma (MM). Eligible patients who are not candidates for transplantation will be randomized to receive eight courses of Melphalan/Prednisolone with or without Thalidomide treatment. Thalidomide will be initiated at the dose of 100 mg/day and maintained at 100 mg/day. The patients will be assessed for any responses at the end of 2nd, 4th, 6th and 8th cycles of treatment. The toxicities will be assessed at monthly intervals. Patients will be assessed for the:
1. Incidence and grade of any toxicity
2. Level of maximum disease response
3. Time to disease progression
4. Time to death
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Thalidomide, DRUG: Melphalan+Prednisolone
Location: Turkey
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Age above 55 years.
* Diagnosis of MM (Appendix A) and staging (Appendix B), previously untreated.
* Performance status ECOG, 0, 1, or 2 (Appendix C).
* Written informed consent to the study medications and bone marrow biopsy at diagnosis, 12 weeks and 6 months and/or off-study assessment.
* Women who are pregnant or lactating at the time of diagnosis are ineligible. All women of child-bearing potential must have a negative pregnancy test within 24hrs of commencing the thalidomide and must take adequate precautions to prevent pregnancy and should not plan on conceiving children during the treatment program:
* Adequate precautions are defined as "at least one highly effective method i.e., IUD, hormonal (birth control pills, injections, or implants), tubal ligation, partner's vasectomy AND one additional effective method i.e., latex condom, diaphragm, cervical cap".
* Women becoming pregnant on protocol will be removed immediately from protocol.
* Male patients (including patients having had a vasectomy) must use barrier contraception during and for four weeks after completing the thalidomide.
* Patients remain eligible in the presence of abnormal renal function and/or liver function at time of enrollment.
* Absence of severe dementia, able to take medication at home.
* Absence of systemic disorders (gastrointestinal, pulmonary, cardiac and neurological).
Exclusion Criteria:
* Asymptomatic myeloma or solitary plasmacytoma of bone or extramedullary plasmacytoma (without evidence of myeloma).
* Previous or concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas.
* Previous treatment for myeloma, except minimal local radiotherapy to relieve bone pain.
* Other illnesses which would preclude chemotherapy administration or patient compliance.
* Any other serious medical or psychiatric illness which would prevent informed consent.
* Peripheral neuropathy > NCI criteria grade 2.
* Pregnant or lactating women and patients of childbearing age who refuse to use contraception.
* History of hypersensitivity to thalidomide or any component of the medications.
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NCT_ID
NCT00934154
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Study_NameMelphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma
| 21,295 |
Study Objectives
This is a prospective, randomized, controlled, unblinded, parallel, multicenter, and non-inferiority study to demonstrate the safety and efficacy of a Food for Special Medical Purpose product (FSMP) in participants with digestive tract tumor undergoing surgical resection during the perioperative period.
Conditions: Gastrointestinal Cancer
Intervention / Treatment:
OTHER: Experimental Product, OTHER: Control Product
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: OTHER
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Participant is male or female, between 18 and 75 years, female participant is non-pregnant or non- lactating, at least 6 weeks postpartum
* Participants with digestive tract tumors diagnosed by histological method or radiological diagnosis and scheduled to undergo surgical resection
* Participant with NRS-2002 score >=3
* Participant is willing to comply with the study protocol, able and willing to consume study product according to the protocol
* Participants with Body Mass Index 18.5 - 30 kg/m2
* Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study
Exclusion Criteria:
* Participant has an expected life expectancy < 3 months
* Participant has contraindications to enteral nutrition (such as active gastrointestinal hemorrhage, bowel obstruction, decompensated short bowel syndrome, high flow intestinal fistula, severe intraperitoneal infection, severe gastrointestinal emptying disorder, unstable vital signs, dyscoagulation, severe nausea, vomiting and/or uncontrolled diarrhea/steatorrhoea) that in the opinion of the study physician cannot be corrected
* Participant used parenteral nutrition or had plasma infused, RBC infused, albumin infused, amino acid infused or undergone radiotherapy and/or chemotherapy within 1 week before screening
* Participant with serum Albumin <2.5g/dl at the time of the screening
* Participant has moderate to severe anemia, i.e. Hgb < 90g / L
* Patients who plan to receive endoscopic tumor resection or / and palliative surgery
* Participant has renal dysfunction (serum creatinine > 2 times the upper limit of normal (ULN))
* Participant has liver insufficiency [serum alanine transaminase (ALT) and/or aspartate transaminase (AST) > 2 times the ULN or severe cholestasis (conjugated bilirubin > 2 times the ULN)]
* Participant has severe cardiac insufficiency (e.g., Severe arrhythmia or atrial fibrillation; myocardial ischemia or stent surgery with unstable cardiac function within 3 months prior to screening visit )
* Participant states that he/she has had a significant cardiovascular and cerebrovascular event (e.g., myocardial infarction, stroke) within six months prior to screening visit; or stated history of congestive heart failure
* Participant with type I diabetes, or type II diabetes with fasting blood glucose >=8mmol/L
* Participant has history of significant neurological or psychiatric disorder
* Participant has history of alcoholism, drug abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
* Participant has a known history of allergy or intolerance to any ingredient in the investigational products
* Participant is currently undergoing tumor immunotherapy taking medications/substances that could profoundly modulate appetite, metabolism or inflammatory level
1. Appetite enhancers, pregnancy promoters, steroids (nasal inhalation, topical and optical steroids are acceptable);
2. Anti-inflammatory fat emulsions or other oral nutritional supplementations/drugs containing Omega-3 fatty acids, protein, glutamine, or arginine.
3. Dexamethasone, growth hormone or other drugs affecting metabolism;
* Participant is currently undergoing tumor immunotherapy or taking medications/substances that could profoundly modulate immune function, such as PD1 or PDL1 inhibitors; CTLA-4 inhibitor; Thymosin; Azathioprine; Cyclosporine; Tacrolimus; Tumor necrosis factor antagonist; Lentinan; immune-modulating Chinese medicine
* Participant with active tuberculosis and HIV infection
* Participant participated in any clinical trial within four weeks prior to the screening visit.
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NCT_ID
NCT05301556
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Study_NameFood for Special Medical Purpose in Patients With Digestive Tract Tumor
| 20,877 |
Study Objectives
This study will see whether the addition of more frequent planning CTs during the course of radiation, and of Positron Emission Tomography (PET), a diagnostic test similar to CT, prior to and during a course of radiation may provide information that could potentially be used during the treatment to improve the initial radiation plan.
Conditions: Lung Cancer, Non-Small Cell Lung Cancer
Intervention / Treatment:
DIAGNOSTIC_TEST: PET/CT Scans
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age equal to or more than 18 years
* Patients with NSCLC consenting for radiotherapy to the primary tumor and / or mediastinal / hilar lymph nodes. Prescription doses should be 60Gy or higher.
* Chemo-RT patients of any stage of NSCLC
* Patients with a measurable tumor on CT scan.
* Patients who are able to lie supine for two consecutive 25 minutes sessions.
Exclusion Criteria:
* Trimodality patients who will have surgery within 2 months post RT
* Previous radiotherapy to intended treatment volumes.
* Patients with recurrent disease
* Active malignancy other than lung cancer
* Pregnancy
* Failure to provide written informed consent
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NCT_ID
NCT03403127
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Study_NamePET CT Re-Planning NSCLC (4DCT-PET)
| 5,699 |
Study Objectives
The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate is in controlling multiple myeloma and to study any side effects that may be experienced.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Pamidronate, DRUG: Thalidomide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Patients must have a diagnosis of Multiple myeloma with poor hematopoietic reserve (platelet count <100,000 OR inability to collect adequate PBSC to support autologous transplant (4X106 CD34+cells/kg OR WBC <2,000)
* Patients must not be eligible for UARK 98 <= age <= 035
* Patients must be at least 6 weeks beyond previous chemotherapy
* All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines
Exclusion Criteria:
* Prior bisphosphonate therapy within 30 days prior to study entry
* Serum creatinine > 5 mg/dl, ascites, or serum direct bilirubin > 2.5 mg/dl
* Prior plicamycin or calcitonin within 2 weeks of study entry
* Severe cardiac disease, unstable thyroid disease, or epilepsy
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NCT_ID
NCT00083408
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Study_NameCombination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
| 13,992 |
Study Objectives
The purpose of this study is to evaluate the investigators ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer.
Conditions: Esophageal Cancer
Intervention / Treatment:
DRUG: C11-Choline
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Newly diagnosed or recurrent patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology.
* Ability to tolerate PET imaging
* Prior malignancy is allowed, but the expectation of survival must be that beyond that expected for patients with locally advanced esophageal cancer.
Exclusion Criteria:
* Pregnant or lactating females are not eligible for this pilot study.
* Patients having received chemotherapy in the 3 months prior to registration for any reason
* Patients with metastatic disease requiring chemoradiation for palliation are not allowed.
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NCT_ID
NCT01051479
|
Study_NameA Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer
| 17,340 |
Study Objectives
This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Conditions: Non-small Cell Lung Cancer Metastatic
Intervention / Treatment:
DRUG: Erlotinib, DRUG: Gemcitabine
Location: Romania
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* adult patients, >=18 years;
* advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
* no previous systemic chemotherapy, radiation therapy or immunotherapy;
* Eastern Cooperative Oncology Group (ECOG) >=2.
Exclusion Criteria:
* prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
* active, non-controlled systemic disease;
* any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).
|
NCT_ID
NCT00701558
|
Study_NameA Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer
| 2,869 |
Study Objectives
The primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with locally advanced or metastatic soft tissue sarcoma.
Conditions: Sarcoma, Soft Tissue
Intervention / Treatment:
DRUG: ABT-510 - Thrombospondin-1 mimetic
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 subject will be eligible for study participation if all of the following criteria are met:
* The subject is at least 18 years.
* The subject has histologically confirmed high grade locally advanced or metastatic soft tissue sarcoma (excluding Ewings sarcoma and chondrosarcoma) not amenable to surgery, radiotherapy or combined modality therapy with curative intent.
* The subject must have at least one lesion with measurable disease by RECIST criteria using CT or MRI.
* The subject has received no more than two cytotoxic treatment regimens, not including adjuvant therapy for sarcoma.
* The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 <= age <= 1.
* The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
* The subject must have adequate bone marrow, renal and hepatic function as follows:
* Bone marrow: White blood cell count (WBC) greater than or equal to 3,000/mm3; Platelets; greater than or equal to 100,000/mm3; Hemoglobin greater than or equal to 9.0 g/dL;
* Renal function: Serum creatinine less than or equal to 2.0 mg/dL;
* Hepatic function: Bilirubin less than or equal to 1.5 mg/dL; AST and ALT less than or equal to 1.5 X the upper normal limit (ULN) unless liver metastases are present, then AST and ALT less than or equal to 5.0 x ULN.
* The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy.
* The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.
Exclusion Criteria
A subject will be ineligible for study participation if any of the following criteria are met:
* The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases
* The subjects is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g. low dose Coumadin) for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
* The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g. hemoptysis). The subject has a recent history (within 4 weeks of Study Day 1) or currently exhibits other clinically significant signs of bleeding.
* The subject has received any therapy for sarcoma including chemotherapy, radiotherapy or any investigational therapy.
* The subject exhibits evidence of clinically significant uncontrolled condition(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
* The subject has history of other previous malignancies within five years, with the exception of:Adequately treated in situ carcinoma of the cervix uteri; Basal or squamous cell carcinoma of the skin.
* The subject's life expectancy is less than 12 weeks.
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NCT_ID
NCT00061659
|
Study_NameStudy Evaluating the Safety and Efficacy of ABT-510 in Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma
| 11,969 |
Study Objectives
The advent of checkpoint blockade immunotherapy has revolutionized the management of metastatic non-small cell lung cancer (NSCLC). Despite the promising evidence for deep and durable responses with these agents the majority of patients fail to respond. The investigators hypothesize that a novel strategy combining radiotherapy and intralesional interleukin-2 (IL-2), a signaling molecule and member of the cytokine family involved in the activation of leukocytes and lymphocytes, may overcome resistance to checkpoint blockade therapy and offer significant clinical benefit to patients who fail to respond to checkpoint blockade alone. The investigators propose a microtrial testing the feasibility of a bold combinatorial immunotherapy strategy consisting of radiotherapy (RT), intralesional IL-2, and check-point blockade for metastatic non-small cell lung cancer patients who have progressed after checkpoint inhibition. IL-2 can upregulate PD-1 expression and activate T-cells.
Conditions: METASTATIC NON-SMALL CELL LUNG CANCER
Intervention / Treatment:
DRUG: Intralesional IL-2, DRUG: Nivolumab, DRUG: Pembrolizumab, RADIATION: Radiotherapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Adults >=18 years with histologically proven NSCLC.
* Failure to respond to standard of care checkpoint blockade therapy or previously responding patients who progress on checkpoint blockade therapy.
* ECOG (Eastern Cooperative Oncology Group) performance status score of 0 - 2 (Appendix 1)
* Presence of a candidate treatment lesion (subcutaneous or nodal lesions are preferable but visceral lesions will be considered) accessible and safe for radiotherapy and serial intralesional injections.
* Presence of at least one target lesion (distinct from treatment lesion and outside of treatment lesion radiation field) evaluable for response by RECIST 1.1
* Life expectancy >= 6 months
* The following laboratory results obtained within 14 days of the first study treatment:
* ANC > 1500 cells/ul
* WBC count > 2500/uL
* Lymphocyte count >500/uL
* Platelet count > 100,000/uL
* Hemoglobin > 9 g/dL
* Liver function tests meeting one of the following criteria:
* AST and ALT < 2.5 x ULN with alkaline phosphatase < 2.5 x ULN OR
* AST and ALT < 1.5 x ULN, with alkaline phosphatase > 2.5 x ULN
* Serum bilirubin <= 1.0 x ULN.
* INR and aPTT <= 1.5 x ULN.
* Creatinine clearance > 30 mL/min by Cockcroft-Gault formula.
* No other active malignancy.
* For female patients of childbearing potential and male patients with partners of childbearing potential agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [<1% per year] when used consistently and correctly) and to continue its use for 6 months after trial completion.
* Signed informed consent.
* Ability to comply with the protocol.
* Systolic >=80.
Exclusion Criteria:
* Uncontrolled concomitant disease.
* History of severe autoimmune disease.
* Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment (with the exception of checkpoint blockade therapy).
* Treatment with systemic corticosteroids or other systemic immunosuppressive medications within past 4 weeks or 5 half-lives whichever is shorter.
* Pregnant and/or lactating women.
* Patients unable to tolerate checkpoint inhibitor therapy.
* Grade 3 or 4 non-hematological, treatment-related AEs.
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NCT_ID
NCT03224871
|
Study_NameUCDCC#269: A Pilot Study of Interlesional IL-2 and RT in Patients With NSCLC.
| 20,817 |
Study Objectives
The primary objective of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with advanced solid tumors.
Conditions: Advanced Solid Tumors
Intervention / Treatment:
DRUG: AMG 994, DRUG: AMG 404
Location: Poland, Germany, United States, Spain, Australia, United Kingdom, Japan, Belgium, Canada, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
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Inclusion Criteria:
* Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
* Age >= 18 years at the time of signing informed consent.
* Life expectancy of > 3 months, in the opinion of the investigator.
* Participant must have histologically or cytologically proven metastatic or locally advanced solid tumors of known MSLN expression who have relapsed after and/or are refractory to established and available therapies with known clinical benefit, for which:
* No standard systemic therapy exists; or
* Standard systemic therapy has failed or is not available.
* Dose Expansion (Part 2): Participant must have one of the following malignancies: mesothelioma, pancreatic adenocarcinoma, MSLN positive NSCLC squamous cell carcinoma or adenocarcinoma, high grade serous ovarian carcinoma.
* At least 1 measurable or evaluable lesion as defined by modified RECIST 1.1 guidelines.
* Participants must be willing to undergo a biopsy prior to enrollment and during treatment with AMG 994.
* Participants with treated brain metastases are eligible provided they meet the following criteria:
* Definitive therapy was completed at least 2 weeks prior to enrollment.
* No evidence of radiographic central nervous system (CNS) progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.
* Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline, or non-serious CNS diseases that are asymptomatic and deemed irreversible (eg, peripheral neuropathy), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease and has not had a seizure within 1 month prior to the screening visit.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2.
* Hematologic function, as follows (transfusions or growth factor support must not be administered within 7 days prior to obtaining screening labs):
* Absolute neutrophil count (ANC) >= 1.5 x 109/L
* Platelet count >= 75 x 109/L
* Hemoglobin >= 9 g/dL
* Adequate renal laboratory assessments, as follows:
* Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation >= 45 mL/min/1.73 m2
* Hepatic function, as follows:
* Total bilirubin (TBL) <= 1.5 x upper limit of normal (ULN) or <= 3 x ULN for participants with liver metastasis
* Aspartate transaminase (AST) <= 3 x ULN or <= 5 x ULN for participants with liver metastasis
* Alanine aminotransferase (ALT) <= 3 x ULN or <= 5 x ULN for participants with liver metastasis
* Alkaline phosphatase <= 2.5 x ULN or <= 5 x ULN for participants with liver metastasis
Exclusion Criteria:
Disease Related
* Primary brain tumor, untreated or symptomatic brain metastases and leptomeningeal disease.
Other Medical Conditions
* History of other malignancy within the past 2 years, with the following exception[s]:
* Malignancy treated with curative intent and with no known active disease present for >= 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated cervical carcinoma in situ without evidence of disease.
* Adequately treated breast ductal carcinoma in situ without evidence of disease.
* Prostatic intraepithelial neoplasia without evidence of prostate cancer.
* Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
* Participants with NSCLC squamous cell carcinoma (Part 1), MSLN negative NSCLC squamous cell carcinoma (Part 2), or MSLN negative NSCLC adenocarcinoma (Part 2) once the participant has been screened for MSLN expression.
* Participants with sarcomatoid mesothelioma and small cell lung cancer will be excluded from both the Dose Exploration (Part 1) and Dose Expansion (Part 2) parts of the study.
* History of solid organ transplantation.
* Major surgery within 28 days of study day 1.
Prior/Concomitant Therapy
* Anti-tumor therapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 21 days prior to study day 1.
* Treatment with a checkpoint inhibitor within 9 weeks prior to study day 1.
* Live vaccine therapy within 4 weeks prior to study drug administration.
* Current treatment or within 14 days of day 1 with immunosuppressive corticosteroid defined as > 10 mg prednisone daily or equivalent. Steroids with no minimal systemic effect (such as topical or inhalation) are permitted.
Prior/Concurrent Clinical Study Experience
* Currently receiving treatment in another investigational device or drug study, or less than 21 days prior to study day 1 since ending treatment on another investigational device or drug study(ies).
* Evidence of active or radiological sequelae of non-infectious pneumonitis.
* History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis.
* History of allergic reactions or acute hypersensitivity reaction to antibody therapies.
* Positive/non-negative test results for human immunodeficiency virus (HIV).
* Hepatitis B and C based on the following results:
* Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
* Negative HBsAG and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
* Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
* Active infection requiring oral or intravenous therapy.
* Active or history of any autoimmune disease or immunodeficiencies. Participants with diabetes Type 1, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.
* Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or cardiac arrhythmia requiring medication.
* Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or are stable and well controlled with minimal, local, or noninvasive intervention AND there is agreement to allow by both the investigator and the Amgen Medical Monitor.
* Any history of grade 3 or higher colitis, pneumonitis, or neurological toxicity OR
* Unresolved toxicities from prior checkpoint inhibitor therapy, defined as not having resolved to CTCAE v5.0 grade 1.
* Exception: - clinically stable hypothyroid status managed with hormone replacement therapy, is permitted
Other Exclusions
* Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of AMG 994 and/or AMG 404.
* Female participants of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 months after the last dose of AMG 994 and/or AMG 404.
* Female participants of childbearing potential with a positive pregnancy test assessed at day 1 by a serum pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 8 months after the last dose of AMG 994 and/or AMG 404.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional 8 months after the last dose of AMG 994 and/or AMG 404.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
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NCT_ID
NCT04727554
|
Study_NameStudy of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors
| 21,357 |
Study Objectives
This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of the combination of quizartinib and induction and consolidation chemotherapy.
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Quizartinib, DRUG: Cytarabine, DRUG: Idarubicin, DRUG: Daunorubicin
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* No prior treatment for AML (including quizartinib)
* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 2
Exclusion Criteria:
* Diagnosis of acute promyelocytic leukemia
* Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy.
|
NCT_ID
NCT02834390
|
Study_NameStudy of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
| 14,207 |
Study Objectives
This pilot phase II trial studies how well giving bevacizumab and combination chemotherapy together before surgery works in treating patients with locally advanced esophageal or stomach cancer. Monoclonal antibodies, such as bevacizumab, 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. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Conditions: Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Squamous Cell Carcinoma of the Esophagus, Stage IA Esophageal Cancer, Stage IA Gastric Cancer, Stage IB Esophageal Cancer, Stage IB Gastric Cancer, Stage IIA Esophageal Cancer, Stage IIA Gastric Cancer, Stage IIB Esophageal Cancer, Stage IIB Gastric Cancer, Stage IIIA Esophageal Cancer, Stage IIIA Gastric Cancer, Stage IIIB Esophageal Cancer, Stage IIIB Gastric Cancer, Stage IIIC Esophageal Cancer, Stage IIIC Gastric Cancer
Intervention / Treatment:
BIOLOGICAL: bevacizumab, DRUG: oxaliplatin, DRUG: leucovorin calcium, DRUG: fluorouracil, PROCEDURE: therapeutic conventional surgery, OTHER: laboratory biomarker analysis
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 biopsy proven adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the esophagus, GE junction and/or gastric cardia
* Patients must have potentially resectable disease by the thoracic, minimally invasive or transhiatal approach
* No portion of the lesion may be within 5 cm of the cricopharyngeus
* Patient must be considered medically fit for surgery with average or below average risk
* T1 <= age <= 3 or T4 with local invasion confined to diaphragm, pleura or pericardium
* No myocardial infarction within 12 months of enrollment
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* White blood cells (WBC) >= 3,500/mm^3
* Platelet count >= 100,000/mm^3
* Serum creatinine (Cr) =< 1.5 mg and/or creatinine clearance >= 60 cc/min
* Bilirubin must be < upper limit of normal (ULN) unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin
* Alkaline phosphatase must be < ULN
* Aspartate aminotransferase (AST) & alanine aminotransferase (ALT) must be < ULN
* Urine protein/creatinine (UPC) ratio of < 1.0 or dipstick for protein of < 2+, Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4) grade < 2; patients with a UPC ratio >= 1.0 or dipstick of 2+ must undergo a 24-hour urine collection and must demonstrate < 1 gm of protein in order to participate
* Patients must give written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent
Exclusion Criteria:
* Patients with prior chemotherapy for any malignant disorder, thoracic radiotherapy or prior surgical resection of an esophageal tumor are ineligible
* Patients with biopsy-proven invasion of the tracheobronchial tree or tracheo-esophageal fistula are ineligible
* Patients with a history of a curatively treated malignancy must be disease-free for at least two years and have a survival prognosis that is greater than five years
* Eligible patients of reproductive potential (both sexes) must agree to use an accepted and effective method of contraceptive during study therapy and for at least 6 months after the completion of bevacizumab; women must not be pregnant or breast-feeding because the study drugs administered may cause harm to an unborn fetus or breastfeeding child; all females of childbearing potential must have a serum pregnancy test to rule out pregnancy within 7 days prior to registration
* Patients with a history of hypertension must measure < 150/90 mmHg and be on a stable regimen of anti-hypertensive therapy; patients with a history of hypertension who have a blood pressure of 150/90 mmHg, or greater are not eligible; patients with a history of hypertension who have a blood pressure of < 150/90 mmHg but are not on a stable regimen of anti-hypertensive therapy, are not eligible
* Any prior history of hypertensive crisis or hypertensive encephalopathy
* New York Association (NYHA) grade II or greater congestive heart failure
* Patients must not have a serious or non-healing wound, skin ulcers or unhealed bone fracture, or known human immunodeficiency virus (HIV) infection
* Patients with >= grade 2 neuropathy are not eligible
* Patients must not have had significant traumatic injury within 28 days prior to randomization
* Patients with PT (INR) > 1.5 are not eligible; the patient may not be receiving full-dose anticoagulation; prophylactic or full dose anticoagulation are permitted post-resection or for treatment of an intercurrent thrombotic event
* Patients with non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs are not eligible; specifically excluded are the following conditions: current symptomatic arrhythmia, symptomatic peripheral vascular disease
* Patients with a history of the following within 12 months of study entry are not eligible: arterial thromboembolic events, unstable angina
* Any history of stroke or transient ischemic attack
* Significant vascular disease (i.e. aortic dissection, aortic aneurysm)
* Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible
* Distant metastases
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
* Known hypersensitivity to any component of bevacizumab
|
NCT_ID
NCT01212822
|
Study_NameBevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advanced Esophageal or Stomach Cancer
| 2,961 |
Study Objectives
RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in treating patients with refractory solid tumors.
Conditions: Adult Solid Tumor, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Adult Central Nervous System Germ Cell Tumor, Adult Teratoma, Benign Teratoma, Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, Familial Testicular Germ Cell Tumor, HER2-negative Breast Cancer, HER2-positive Breast Cancer, Male Breast Cancer, Ovarian Immature Teratoma, Ovarian Mature Teratoma, Ovarian Monodermal and Highly Specialized Teratoma, Progesterone Receptor-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Recurrent Colon Cancer, Recurrent Extragonadal Germ Cell Tumor, Recurrent Extragonadal Non-seminomatous Germ Cell Tumor, Recurrent Extragonadal Seminoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Melanoma, Recurrent Ovarian Germ Cell Tumor, Recurrent Rectal Cancer, Stage III Extragonadal Non-seminomatous Germ Cell Tumor, Stage III Extragonadal Seminoma, Stage III Malignant Testicular Germ Cell Tumor, Stage III Ovarian Germ Cell Tumor, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Extragonadal Non-seminomatous Germ Cell Tumor, Stage IV Extragonadal Seminoma, Stage IV Melanoma, Stage IV Ovarian Germ Cell Tumor, Stage IV Rectal Cancer, Testicular Immature Teratoma, Testicular Mature Teratoma
Intervention / Treatment:
DRUG: PD-0332991
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:
* Disease Characteristics:
All Subjects: All subjects treated under this protocol will have histologically documented cancer of one of the following types:
A. Metastatic breast cancer (7 triple negative, 23 ER+ after the first 15 patients are enrolled on the non-CCND1cohort; in addition 10 HER2+ for combination trastuzumab and PD0332991 therapy) up to 55 total enrollment slots B. Metastatic colorectal cancer that harbors the Kras or BRAF mutation (15 <= age <= 30 enrollment slots) C. Advanced or metastatic esophageal and/or gastric cancer (15 <= age <= 30 enrollment slots) D. Cisplatin-refractory, unresectable germ cell tumors (15 <= age <= 30 enrollment slots) E. Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation, CCND2 amplification OR any other functional alteration at the G1/S checkpoint. (15 <= age <= 30 enrollment slots)
* Biopsy Requirements: For Subjects with accessible disease amenable to biopsy: A biopsy will be obtained pre-treatment and in during cycle 1 (while patient is receiving drug) for molecular markers of the cell cycle, and its inhibition.
* Subjects will be > 18 years
* The subject has disease that is assessable by tumor marker, physical, or radiologic means.
* The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* The subject has adequate organ function, defined as follows A. Bilirubin <= 1.5 x the upper limit of normal (ULN) B. Serum creatinine <= 1.5 x UNL or calculated creatinine clearance >= 60 mL/min, and C. For subjects without liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN D. For subjects with liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase <= 5 x ULN
* All tumors must test positive for Rb expression except:
A. ER positive metastatic breast tumors (data now shows all to be Rb positive.) B. Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation, CCND2 amplification OR any other functional alteration at the G1/S checkpoint.
* The subject has adequate marrow function, defined as follows: A. Absolute neutrophil count (ANC) >1500/mm3 B. Platelets >100,000/mm3, and C. Hemoglobin > 9 g/dL
* The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
* Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study and for 3 months after the last dose of protocol drug(s).
* Female subjects of childbearing potential must have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months.
* However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, or ovarian suppression.
Exclusion Criteria
* The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first dose of PD 0332991. . Patients with HER2-overexpressing tumors may receive trastuzumab up to the date of starting therapy, and may continue to receive trastuzumab while receiving PD0332991.
* The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
* The subject has not recovered from clinically-meaningful toxicity due to prior therapy (i.e., back to baseline or Grade <= 1), with the exception of neurotoxicity and alopecia.
* The subject has untreated or uncontrolled brain metastases or evidence of leptomeningeal involvement of disease unless the subject has a teratoma in which case s/he may be eligible if all other eligibility criteria are met
* The subject has uncontrolled intercurrent illness including, but not limited to:
1. ongoing or active infection
2. diabetes mellitus
3. hypertension
4. symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months
* The subject has a baseline corrected QT interval (QTc) > 470 ms.
* The subject is pregnant or breastfeeding.
* The subject is known to be positive for the human immunodeficiency virus (HIV). Note:
baseline HIV screening is not required
* The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
|
NCT_ID
NCT01037790
|
Study_NamePhase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
| 14,172 |
Study Objectives
This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Conditions: Mantle Cell Lymphoma
Intervention / Treatment:
DRUG: rituximab [MabThera/Rituxan], DRUG: First line chemotherapy
Location: Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* histologically-proven mantle cell lymphoma;
* previously untreated disease at stage II, III and IV, requiring therapy.
Exclusion Criteria:
* known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
* active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
* serious disorders interfering with full standard dosing chemotherapy;
* stage I disease.
|
NCT_ID
NCT00472420
|
Study_NameA Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.
| 2,200 |
Study Objectives
The goal of this clinical research study is to find the highest safe dose of the drug 8-chloro-adenosine that can be given in the treatment of chronic lymphocytic leukemia (CLL). Another goal is to learn how effective the drug is at treating leukemia.
Conditions: Leukemia, Chronic Lymphocytic Leukemia
Intervention / Treatment:
DRUG: 8-Chloro-Adenosine
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 a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment.
* Patients must be Rai Stage III or IV OR Rai Stage 0-II and have one or more criteria for active disease as defined by the NCI-Working Group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time <= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia.
* All patients must have a Zubrod performance status of <= 2.
* All patients must be age >= 18 years.
* Patients may not receive concurrent treatment for their CLL and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy.
* All patients must have adequate renal function indicated by serum creatinine <=2.5x upper limits of normal (ULN) and adequate liver function indicated by ALT or AST <= 2.5x ULN AND total bilirubin <= 2.5x ULN.
* All patients must have a pre-treatment platelet count of >= 50,000 /µl and not require transfusion to maintain this platelet count unless thrombocytopenia is due to marrow infiltrated with disease.
* All patients or appropriate surrogate must provide informed consent.
Exclusion Criteria:
* Patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura.
* Patients with active uncontrolled fungal, bacterial, or viral infection.
* Patients who are pregnant or breast-feeding.
|
NCT_ID
NCT00714103
|
Study_Name8-Chloro-Adenosine in Chronic Lymphocytic Leukemia
| 16,482 |
Study Objectives
The purpose of this project is to refine, implement, and evaluate a multi-component intervention that achieves sustainable and meaningful impact on healthcare quality, safety, and costs while ensuring dignity and respect for adult oncology and intensive care patients and their care partners. The PROSPECT (Promoting Respect and Ongoing Safety through Patient-centeredness, Engagement, Communication, and Technology) framework will achieve this by enhancing the patient-provider relationship and introducing patient-centered approaches to multi-disciplinary communication and patient education. The PROSPECT framework is based upon a validated structured, team-work training model and novel web-based technology. The overarching goals of this project are to achieve the following:
1. Optimize the overall experience of patients (including their family/care partners) by promoting dignity/respect, encouraging engagement, improving care plan concordance, and enhancing satisfaction.
2. Minimize preventable harms in two environments: intensive care and acute care oncology units.
3. Reduce unnecessary healthcare resource utilization and associated costs.
Conditions: Medical Intensive Care Unit (MICU) Patients, Oncology Unit Patients
Intervention / Treatment:
OTHER: Web-Based Patient Centered Toolkit (PCTK), BEHAVIORAL: The Patient-SatisfActive® Model
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Age > 18
* Any patient admitted or transferred to designated care units
* Admitted or transferred to a MICU or Oncology service
* On the designated unit for at least 24 hours
Exclusion Criteria:
* Age < 18
* Any patient admitted or transferred to designated care unit but NOT on a MICU or Oncology service
|
NCT_ID
NCT02258594
|
Study_NamePromoting Respect and Ongoing Safety Through Patient-centeredness, Engagement, Communication and Technology
| 5,592 |
Study Objectives
This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with actinic keratosis on the upper extremities for the first time.
Conditions: Actinic Keratoses
Intervention / Treatment:
DRUG: PD P 506 A
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Written informed consent has been signed prior to or at Screening Visit
* Caucasian male and female patients
* Age >= 18 years
* Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on the upper extremities
* Selected AK study lesions have clearly defined margins and are mild to severe (grades I to III):
* Mild grade (I): Slight palpability, better felt than seen
* Moderate grade (II): Moderately thick AK, easily felt
* Severe grade (III): Very thick and/or obvious AK
* Skin sun sensitivity type I to IV according to Fitzpatrick
Exclusion Criteria:
* PDT Non-responder
* Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding PDT (e.g. antineoplastic topical formulations as e.g. Metvix®, Ameluz®, Luxerm®, Solaraze®, Aldara®, Picato®, Actikerall®, 5-FU or vitamin A acid containing formulations)
* Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding PDT with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
* Pre-treatment with hypericin during the 2 weeks preceding PDT
* Treatment with systemic retinoids during the 3 months preceding PDT
* Treatment with cytostatics or radiation during the 3 months preceding PDT
* Female patients of childbearing potential (A female is considered of childbearing potential unless she has had tubal ligation, hysterectomy or has been postmenopausal, i.e. with spontaneous amenorrhea for at least 12 months.)
* Patients with clinically relevant suppression of the immune system
* Diagnosis of Porphyria
* Known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematosus or pemphigus erythematosus
* Concomitant use of medicinal products with known phototoxic or photoallergic potential such as hypericin, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines
* Skin diseases that might interfere with response evaluation of study PDT
* Skin sun sensitivity type V or VI according to Fitzpatrick
* Known intolerance to one or more of the ingredients of the study medication
* Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
* Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
* Suspected lack of compliance
|
NCT_ID
NCT03606122
|
Study_Name5-ALA Patch-PDT of Actinic Keratosis on the Upper Extremities
| 2,557 |
Study Objectives
Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Docetaxel, DRUG: Bortezomib
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Prostate cancer, and objective evidence of metastatic disease
* Progression while receiving androgen ablation therapy
* No previous chemotherapy
* Measurable or evaluable disease in conjunction with elevated serum PSA levels
* ECOG performance status 0, 1, or 2
* Adequate bone marrow, liver and kidney function
* Voluntarily provide written informed consent
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
* Moderate or severe peripheral neuropathy
* Age < 18 years
* Other serious medical conditions that may interfere with protocol therapy
* Other active malignancies
* history of treatment for other invasive cancers within 3 years
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
|
NCT_ID
NCT00193232
|
Study_NameWeekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer
| 15,586 |
Study Objectives
This study is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. No control groups were considered in the study design. The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).
Conditions: Multiple Myeloma, Refractory
Intervention / Treatment:
DRUG: Bortezomib
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Patients with multiple myeloma were included in the study.
Exclusion Criteria:
* There were no exclusion criteria for this study.
|
NCT_ID
NCT06012383
|
Study_NameAlvocade® (Bortezomib) Safety and Effectiveness Study
| 20,583 |
Study Objectives
Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent endometrial cancer. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor
Conditions: Endometrial Adenoacanthoma, Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Recurrent Endometrial Carcinoma
Intervention / Treatment:
DRUG: thalidomide, OTHER: laboratory biomarker analysis
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:
* Histologically confirmed endometrial carcinoma
* Recurrent or persistent (refractory to curative therapy or established treatment)
* No sarcomas
* At least 1 unidimensionally measurable lesion
* At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI
* At least 10 mm by spiral CT scan
* At least 1 target lesion outside the area of prior radiotherapy
* Received 1 prior chemotherapy regimen for endometrial carcinoma
* Initial treatment may include high-dose therapy, consolidation, or extended therapy
* No more than 1 additional cytotoxic regimen for recurrent or persistent disease
* No non-cytotoxic chemotherapy for recurrent or persistent disease
* Ineligible for higher priority GOG protocols (any active GOG phase III protocol for the same patient population)
* No documented brain metastases since diagnosis of cancer
* Patients with stable CNS deficits allowed provided there are no brain metastases, as confirmed by CT scan or MRI
* Performance status - GOG 0 <= age <= 2 if patient received 1 prior regimen
* Performance status - GOG 0 <= age <= 1 if patient received 2 prior regimens
* Absolute neutrophil count at least 1,500/mm^3
* Platelet count at least 100,000/mm^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance greater than 60 mL/min
* Not pregnant
* Negative pregnancy test
* Fertile patients must use 2 methods of effective contraception for 4 weeks before, during, and for 4 weeks after study participation
* No active infection requiring antibiotics
* No sensory or motor neuropathy greater than grade 1
* No other invasive malignancy within the past 5 years except non-melanoma skin cancer
* No documented seizure disorders since diagnosis of cancer
* Patients with a history of seizure disorders allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen
* At least 3 weeks since prior biologic or immunologic agents directed at malignancy
* No prior thalidomide
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy directed at malignancy and recovered
* At least 1 week since prior hormonal therapy directed at malignancy
* Concurrent hormone replacement therapy allowed
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy directed at malignancy and recovered
* No prior radiotherapy to more than 25% of marrow-bearing areas
* Recovered from prior surgery
* At least 3 weeks since any other prior therapy directed at malignancy
* No prior cancer therapy that would preclude study participation
* No concurrent bisphosphonates (e.g., zoledronate)
|
NCT_ID
NCT00025467
|
Study_NameThalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
| 9,637 |
Study Objectives
The primary purpose of this study is to determine the differences in PFS for participants who have been receiving brigatinib as ALK inhibitor therapy for ALK+NSCLC compared to those participants receiving alectinib, ceritinib, lorlatinib, or other ALK inhibitors that may become available during study treatment.
Conditions: Anaplastic Lymphoma Kinase-positive, Carcinoma Non-small-cell Lung
Intervention / Treatment:
DRUG: Brigatinib, DRUG: Alectinib, DRUG: Ceritinib, DRUG: Lorlatinib, DRUG: Any FDA Approved ALK Inhibitors
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Has ALK+ NSCLC.
* Has been prescribed:
* Brigatinib at any point in therapy, OR
* Any FDA approved ALK inhibitor at any point in therapy other than crizotinib. Participants who were previously on crizotinib, but are now on another ALK inhibitor are eligible for study participation.
* Has internet access.
* Is willing to answer regular e-surveys and allow for the prescriber or clinic to provide data on the status of the participant's NSCLC.
Exclusion Criteria:
* Has received any investigational compound within 90 days prior to consent.
|
NCT_ID
NCT03546894
|
Study_NameA Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors
| 5,539 |
Study Objectives
In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically when immediately followed by the non-specific immune stimulation provided by treatment with HD IL-2 and thereby increase the response rate and complete response for metastatic clear cell renal cell cancer patients. Both HD IL-2 and SABR are FDA approved therapeutic cancer treatment
Conditions: Metastatic Clear Cell Renal Cell Carcinoma
Intervention / Treatment:
DRUG: IL-2, RADIATION: Stereotactic Ablative Body Radiation Therapy
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:
* Biopsy-proven metastatic clear cell RCC.
* Radiographic evidence of metastatic disease. 2.1 Patients with any number of metastatic site are allowed to enroll. However, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist.
* Patient must have >=1 lesion of size >1.5cm.
* Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed 28 days before the start of HD IL-2
* Age >= 18 years.
* Performance status ECOG 0, 1.
* Patient must be eligible for HD IL-2 treatment
* Patient must be eligible for SABR to one or more extra cranial sites.
* Adequate organ and marrow function as defined below:
* leukocytes >= 3,000/mcL
* absolute neutrophil count >= 1,500/mcL
* platelets >= 50,000/mcl
* total bilirubin <= 2mg/dL
* AST(SGOT)/ALT(SPGT) <= 2.5 X institutional upper limit 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
10.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
* Ability to understand and the willingness to sign a written informed consent
* Adequate Renal function with Cr <= 1.6 mg/dL.
* Adequate cardiac function (adequate perfusion; no ischemia) on thallium (or Tc) stress test
* Adequate pulmonary function on PFT (FEV1 >65%; DLCO>60%).
Exclusion Criteria:
* Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
* History of HIV, Hepatitis B, Hepatitis C and HTLV serology
* Subjects may not be receiving any other investigational or standard antineoplastic agents.
* Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis
* Subjects with life expectancy < 6 months.
* History of allergic reactions to recombinant IL-2
* Uncontrolled recurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,.
* Psychiatric illness/social situations that would limit compliance with study requirements.
* Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
* Systemic or topical steroid use or other immunosuppressive therapy within the past 28 days
* Subjects required to take corticosteroids or other immunosuppressive therapy such as those with organ allograft
|
NCT_ID
NCT01896271
|
Study_NameHigh Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer
| 18,032 |
Study Objectives
Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with
* Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m\^2 i.v. day 1 q3 weeks),
* Paclitaxel (175 mg/m\^2 i.v. day 1 q3 weeks), and
* Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor size \<25% after 4 courses measured by ultrasound or MR-mammography), or if the patient requested to be released.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Myocet (Non-pegylated liposomal doxorubicin (NPLD)), DRUG: Paclitaxel, DRUG: Lapatinib (GW572016, Tykerb)
Location: Germany
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 breast cancer
* T1c N1 <= age <= 2 or T2 N0 <= age <= 2 disease
* HER2-positive tumours with 3+ intensity on immunohistochemical staining for HER2 or amplification of the HER2 gene on fluorescence in situ hybridization (FISH)
* No prior systemic treatment regimens for breast cancer
* Adequate hematologic function (ANC 1500 cells/µl, platelet count 100000/µl, and hemoglobin 8g/dl).
* Serum creatinine concentration < 1.5 times the upper limit of normal (ULN) and/or creatinine clearance >60 ml/min
* Bilirubin level < 1.5 X ULN
* Normal cardiac function with a left ventricular ejection fraction of at least 50% (as assessed by quantitative echocardiogram or MUGA scan)
* Karnofsky performance status 80%
* Age 18 years
* If the patient is of childbearing potential, she agrees to: comply with effective contraceptive measures, has been using adequate contraception since the last menses, will use adequate contraception during the study, and has a negative pregnancy test within one week of study entry
* Written informed consent prior to admission to this study
Exclusion Criteria:
* Male patients
* Inflammatory or bilateral breast cancer
* Evidence of distant metastases
* Previous systemic or local treatment for breast cancer (including surgery, radiotherapy, cytotoxic and endocrine treatments)
* Past or current history of other neoplasms, except for
* Curatively treated non-melanoma skin cancer
* Adequately treated in situ carcinoma of the cervix
* Other cancer curatively treated and with no evidence of disease for at least 5 years
* Significant cardiac disease, including angina pectoris, severe cardiac arrhythmia requiring medication, severe conduction abnormalities, clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, poorly uncontrolled hypertension (resting diastolic blood pressure >115 mmHg), prior myocardial infarction, CHF, or other cardiomyopathy
* Preexisting sensoric or motor polyneuropathy Grade 2 according to NCI CTC
* Serious intercurrent medical or psychiatric illness, including serious active infection
* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.
* Detained persons or prisoners
* Pregnant or nursing women
|
NCT_ID
NCT01172223
|
Study_NamePrimary Chemotherapy in Patients With HER2-positive Early Breast Cancer
| 12,874 |
Study Objectives
The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.
Conditions: Myelodysplastic Syndromes, MDS, RAEB, Chronic Myelomonocytic Leukemia
Intervention / Treatment:
DRUG: ON 01910.Na
Location: Germany, United States, Spain, Italy, Belgium, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* MDS diagnosis confirmed within 6 weeks prior to entry according to WHO or FAB classification
* MDS classified as follows, according to WHO and FAB classification:
* RAEB-1 (5% - 9% BM blasts)
* RAEB-2 (10% - 19% BM blasts)
* CMML (10% - 20% BM blasts) and WBC < 13,000/μL
* RAEB-t (20% - 30% BM blasts), with following criteria:
* o WBC < 25 x 10E9/L at entry
* o Stable WBC at least 4 weeks prior to entry and not requiring intervention for WBC control with hydroxyurea, chemotherapy, or leukopheresis.
* At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin <10 g/dL)
* Progression according to 2006 International Working Group (IWG) criteria any time after start of azacitidine or decitabine during past 2 years; or failure to achieve complete or partial response or hematological improvement (according to 2006 IWG) after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine during past 2 years; or relapse after initial complete or partial response or hematological improvement (according to 2006 IWG criteria) observed after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine during past 2 years; or, intolerance to azacitidine or decitabine defined by drug-related >=Grade 3 liver or renal toxicity leading to discontinuation during the past 2 years.
* Did not respond to, relapsed after, not eligible for, or opted not to do bone marrow transplantation
* Off other MDS treatments for at least 4 weeks; Filgrastim (G-CSF) and erythropoietin allowed before and during the study as clinically indicated.
* No need for induction chemotherapy
* ECOG status 0, 1 or 2
* Willing to adhere to protocol prohibitions and restrictions
* Patient (or a legally authorized representative) must sign informed consent form to indicate patient's understanding study's purpose and procedures and willingness to participate
Exclusion Criteria:
* Anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding) unless stabilized for 1 week after RBC transfusion.
* Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* Active infection not adequately responding to appropriate therapy
* Total bilirubin >=1.5 mg/dL not related to hemolysis or Gilbert's disease.
* Alanine transaminase (ALT)/aspartate transaminase (AST) >=2.5 x upper limit of normal (ULN)
* Serum creatinine >=2.0 mg/dL
* Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <130 mEq/L)
* Pregnant or lactating females
* Patients unwilling to follow strict contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device, double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study
* Females with reproductive potential who do not have a negative urine beta-human chorionic gonadotropin pregnancy test at screening
* Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start
* Uncontrolled hypertension (defined as systolic pressure >=160 mmHg and/or diastolic pressure >=110 mmHg)
* New onset seizures (within 3 months prior to first dose of ON 01910.Na) or poorly controlled seizures
* Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy
* Prior treatment with low-dose cytarabine during past 2 years Investigational therapy within 4 weeks of starting ON 01910.Na
* Psychiatric illness or social situation that limits the patient's ability to tolerate and/or comply with study requirements
|
NCT_ID
NCT01241500
|
Study_NameRandomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts
| 12,183 |
Study Objectives
The purpose of this study is to determine whether initial local irradiation with topotecan and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective in the treatment of pediatric diffuse brainstem tumor.
Conditions: Brainstem Glioma
Intervention / Treatment:
DRUG: Thalidomide, etoposide, celecoxib
Location: Finland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
*pediatric diffuse brainstem tumor
Exclusion Criteria:
* wish of the family
* need for strong painrelievers
* decreased level of consciousness
* inability to swallow.
|
NCT_ID
NCT01756989
|
Study_NameANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors
| 6,295 |
Study Objectives
The objective of LMS04 study is to better define the treatment strategy for patients with metastatic leiomyosarcoma (uterine or soft tissue), as well as identifying the best first line therapeutic option for these patients. LMS04 will test a new strategy for first line therapy LMS sarcoma compare to the reference therapy (6 cycles of doxorubicin alone): the interest of the association of trabectedin to doxorubicin in first line treatment followed by trabectedin alone for non-progressive patients after 6 cycles of the association of trabectedin and doxorubicin (the LMS02 design).
LMS04 will be the first phase III randomized study specifically dedicated to soft tissue leiomyosarcoma in first line metastatic disease.
It is planned to compare a new doxorubicin combination (including trabectedin) with very encouraging results followed by trabectedin maintenance therapy for non-progressive patients to doxorubicin alone. Prospective ancillary translational studies will attempt to define profiles of patients who could benefit from this new chemotherapy in an exploratory way.
The validation of a new first line option specific for LMS, identifying clinical factors that characterize aggressiveness and responsiveness to treatment aims to have an important in the spirit of personalized medicine in this rare and deadly disease.
Conditions: Uterine or Soft Tissue Leiomyosarcoma
Intervention / Treatment:
DRUG: Doxorubicin, DRUG: Trabectedin
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patients must have histologically confirmed diagnosis of metastatic or relapsed unresectable uterine or soft tissue leiomyosarcoma, reviewed in a reference center (among RREPS network), previously untreated with chemotherapy , and with available Formalin Fixed Paraffin Embedded (FFPE) blocks
* At least one measurable lesion according to RECIST V 1.1 criteria. Target could be in a previously irradiated field but has to be progressive or a biopsy had to be positive before inclusion.
* Age >= 18 years
* ECOG performance status < 2 (Appendix 4)
* Adequate haematological, liver and cardiac functions:
* Neutrophil counts >= 1500/mm3
* Platelets >= 100 000/mm3
* Serum creatinin < 1.5 x Upper Limit of Normal Value (UNL)
* Serum bilirubin <=1 x ULN
* ALT, AST <= 2.5 x ULN
* Alcaline phosphatases <= 1.5 x ULN
* Cardiac ultrasound and/or normal isotopic ventriculography : Shortening Fraction (SF) > 30%, Left Ventricular Ejection Fraction (LVEF) > 50%
* Creatinin phosphokinase (CPK) <= 2.5 x ULN
* Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to inclusion. Both males and WOCBP who are sexually active should be using an effective birth control method from inclusion (for WOCBP) or treatment initiation (for male) and up to 6 months following the last dose of study drug.
* Signed written informed consent form
* Patient affiliated to a social security regimen or beneficiary of the same
Exclusion Criteria:
* All other histological types of uterine sarcomas or soft tissue sarcomas
* Any contraindication for the use of trabectedin and/or doxorubicin (cardiac, renal, hepatic, known hypersensitivity...)
* Patient already enrolled in another therapeutic trial involving an investigational substance, and when such a substance has been taken during the previous 4 weeks.
* Medical history of progressive psychiatric disorder
* History of another type of cancer not in complete remission for more than 3 years prior to study entry (except for cutaneous basal cell carcinoma or in situ cervical epithelioma), and/or having required any chemotherapy treatment at any time.
* Known cerebral metastasis
* History of allograft or autograft
* Active viral hepatitis B or C or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection
* Pregnant women or nursing mothers
* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or any condition (e.g., psychological instability, geographical location, social reason, etc.) that, in the judgment of the Investigator, may affect the patient's ability to understand and sign the informed consent or to fully comply with all study visits, treatments, procedures, and other requirements scheduled in the protocol.
|
NCT_ID
NCT02997358
|
Study_NameStudy Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin Versus Doxorubicine in Patients With Leiomyosarcoma
| 4,499 |
Study Objectives
The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.
Conditions: Crohn's Disease
Intervention / Treatment:
BIOLOGICAL: Certolizumab pegol
Location: Belgium, Germany, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI) >= 220 and <= 450] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) >= 8
* Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy
Exclusion Criteria:
* Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome
* History of tuberculosis or positive tests for tuberculosis at screening
* All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
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NCT_ID
NCT00297648
|
Study_NameMucosal Healing Study in Crohn's Disease (CD)
| 1,154 |
Study Objectives
The purpose of this study is to provide eribulin to patients with advanced breast cancer who have no other treatment options and therapy is requested by an Investigator.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Eribulin Mesylate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria
In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol:
* Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy.
* Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:
* Anthracyclines, taxanes, and capecitabine.
* Ixabepilone in countries where this agent is marketed.
* Trastuzumab for Her-2 positive disease.
* Hormonal therapy in hormone receptor-positive disease.
* All other marketed therapies, eg, gemcitabine or vinorelbine, used for the treatment of advanced breast cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
* Serum creatinine <= 2.0 mg/dL or creatinine clearance >= 40 mL/min according to Cockcroft and Gault formula.
* Absolute neutrophil count >= 1.5 x 10^9/L, hemoglobin >= 10 g/dL (can be corrected by growth factor or transfusion), and platelet count >= 100 x 10^9/L.
* Total bilirubin <= 1.5 x upper limit of normal (ULN). Alkaline phosphatase (AP), alanine aminotransferase, and aspartate aminotransferase <= 3 x ULN (<= 5 x ULN in case of liver metastases). In case AP is >3 x ULN (in absence of liver metastases) or >5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.
* Are willing and able to comply with all aspects of the treatment protocol.
* Provide written informed consent.
* Females, age >= 18 years.
* Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intra-uterine device, or have a vasectomised partner) having started for at least one menstrual cycle prior to starting eribulin and throughout the entire treatment period and for 30 days (longer if appropriate) after the last dose of eribulin. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the treatment protocol:
* Eligible for any other eribulin study that is open in the same region.
* Existing anti-cancer therapy-related toxicities of Grade >= 2, except that alopecia and Grade 2 neuropathy are acceptable.
* History of congestive heart failure with New York Heart Association Classification >II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia.
* Electrocardiogram with QTc interval >= 500 msec based upon Bazett's formula (QTcB).
* The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason.
* Females who are pregnant (positive B-hCG test) or breastfeeding.
* Subject with hypersensitivity to eribulin or any of the excipients.
* Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol.
* Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the treatment protocol.
* Subjects who are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection.
* Subjects with meningeal carcinomatosis.
* Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
* Subjects who have received any of the following treatments within the specified period before the start of treatment:
* Any investigational drug, chemotherapy, radiation, or biological or targeted therapy within 2 weeks.
* Hormonal therapy within 1 week.
|
NCT_ID
NCT01142661
|
Study_NameCompassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies
| 18,639 |
Study Objectives
This study will consider the safety and effectiveness of a study drug, CAN04, in combination with FOLFIRINOX, in the treatment of metastatic pancreatic ductal adenocarcinoma.
Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Intervention / Treatment:
DRUG: CAN04, DRUG: FOLFIRINOX
Location: France, Spain
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* The subject is capable to understand and willing to provide written informed consent before any study-related activities (study-related activities are any procedures that would not have been performed during normal management of the subject's disease).
* The subject is at least 18 years.
* The subject has been diagnosed with stage IV PDAC (Pancreatic Ductal Adenocarcinoma) and is amenable to first-line systemic therapy. The subject must have measurable disease that is histologically or cytologically confirmed.
* The subject has an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
* The subject has a primary or metastatic lesion amenable to biopsy and is willing to undergo repeat biopsies, unless a biopsy would not be safe in the opinion of the investigator and in agreement by the sponsor and medical monitor (or designee).
* The subject has clinically adequate bone marrow, hepatic, and renal function based on clinical laboratory test values at screening within the following ranges:
* Creatinine clearance >30 mL/min calculated by Cockcroft-Gault formula
* Haemoglobin >90 g/L (blood transfusions during the screening period are not allowed)
* Absolute neutrophil count >1.5 × 109/L (usage of growth factors, such as G-CSF (Granulocyte Colony-Stimulating Factor), during the screening period is not allowed)
* Platelets >100 × 109/L
* Total bilirubin <1.5 × ULN unless due to Gilbert's syndrome
* AST and ALT <=3 × ULN (or <5 × ULN for subjects with hepatic metastases)
* The subject has a QT interval corrected using Fridericia's formula (QTcF) of <= 480 milliseconds at screening.
* Female subjects of childbearing potential (more info can be found in the protocol) and male subjects with female partners of childbearing potential must be willing to adhere to contraceptive requirements as detailed in the protocol, from at least 1 month prior to study entry to at least 4 months after the last dose of study treatment.
* The subject has suitable venous access for safe drug administration and the study- required drug concentration and pharmacodynamic sampling.
Exclusion Criteria:
* Subjects who have received previous radical radiotherapy, chemotherapy, or investigational therapy for the treatment of metastatic disease.
* Prior treatment with 5-FU or gemcitabine administered as a radiation sensitiser during and up to 4 weeks after radiation therapy, is allowed; however, if there is lingering toxicity (Grade >1), then the sponsor should be consulted.
* If a subject received adjuvant or neoadjuvant chemotherapy, tumour recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose.
* Subjects with uncontrolled brain metastases; however, subjects are allowed if they have been previously treated with surgery, whole-brain radiation, and/or stereotactic radiosurgery and are considered controlled (with <=10 mg/day of prednisone or equivalent) at the time of receiving the first dose of CAN04. For asymptomatic subjects, screening brain imaging is not required.
* Subjects with endocrine or acinar pancreatic carcinoma.
* Subjects with an active severe infection requiring parenteral antibiotics at the time of enrolment or subjects currently receiving oral antibiotics as a continuation of a previous course of parenteral antibiotics.
* Subjects with peripheral sensory neuropathy Grade >=2.
* Subjects with a serious uncontrolled medical disorder that, in the opinion of the investigator or medical monitor, makes it unwise for the subject to participate in the study or that might jeopardise compliance with the protocol.
* Subjects with psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of AEs (Adverse Events) or has compromised ability to provide written informed consent.
* Subjects with an active second invasive malignancy with the exception of stable prostate cancer on watchful waiting.
* Subjects with uncontrolled or significant cardiovascular disease defined as NYHA (New York Heart Association) classification III or IV.
* Subjects with congenital long QT syndrome.
* Subjects with a history of autoimmune disease requiring systemic immunosuppressive therapy (daily prednisone equivalent doses >10 mg/day).
* Subjects with known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. NOTE: Subjects who have positive hepatitis B core antibody or hepatitis B surface antigen antibody can be included but must have an undetectable hepatitis B viral load.
* Subjects with a known history of any other relevant congenital or acquired immunodeficiency other than HIV infection. NOTE: Subjects testing positive for HIV are NOT excluded from this study, but HIV- positive subjects must meet the following criteria:
* Have CD4+ T-cell (CD4+) counts >=350 cells/µL.
* Have not had an opportunistic infection within the past 12 months. Subjects on prophylactic antimicrobials can be included in the study.
* Should be on established antiretroviral therapy for at least 4 weeks.
* Have an HIV viral load less than 400 copies/mL prior to enrolment.
* Subjects who receive a live vaccination, etanercept, or other TNF-α (Tumor Necrosis Factor-alpha) inhibitors during or just prior to (within 28 days of first dose of study treatment) participation in this study.
* Subjects who have had a hospitalization for bowel obstruction within 12 weeks prior to enrolment.
* Subjects with a known bleeding disorder or coagulopathy. NOTE: Subjects on stable anticoagulant therapy are allowed at the discretion of the investigator; however, these subjects should be monitored more frequently.
* Subjects with a known or suspected allergy to any study treatment or related products, including platinum-based chemotherapeutic agents.
* Female subjects who are pregnant or breastfeeding or trying to become pregnant.
|
NCT_ID
NCT04990037
|
Study_NameA Study of the Safety and Tolerance of CAN04 in Combination With FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
| 15,151 |
Study Objectives
This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy.
FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.
Conditions: Metastatic Colorectal Cancer (mCRC)
Intervention / Treatment:
DRUG: Bevacizumab biosimilar (BEVZ92), DRUG: Avastin® (bevacizumab, reference product)
Location: Ukraine, Spain, Brazil, Argentina, India
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patient must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
* Patient with mCRC for whom bio-chemotherapy is indicated.
* Patients must have at least one measurable non-irradiated site of disease according to RECIST (version 1.1) criteria. If the patient has had previous irradiation of the marker lesion(s), there must be evidence of progression since the radiation.
* Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
* Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
* Adequate bone marrow function
* Adequate liver function defined within specific parameters
* Adequate renal function defined within specific parameters
* Adequate coagulation parameters defined within specific parameters
* Negative pregnancy test for females of a childbearing potential.
* Use of an effective form of contraception during the study (for subjects of childbearing potential and their partners).
* Life expectation >= 3 months
Exclusion Criteria:
* Prior treatment for advanced or metastatic colorectal cancer.
* Prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting.
* Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment).
* History of any other malignancy unless the malignancy is in complete remission and the patient has been off all therapy for that malignancy for at least 5 years.
* Chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed.
* Scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry.
* Uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or lepto-meningeal metastases.
* Patients with active bleeding or history of bleeding diathesis on oral anti-vitamin K medication (except low dose coumadin) within the past 6 month prior to randomization or coagulopathy.
* Patients with history of cerebral vascular accident, transient ischemic attack, or subarachnoid haemorrhage within the past 6 month prior to randomization.
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Patients with serious non-healing wound, ulcer, bone fracture, or with a major surgical procedure, or significant traumatic injury within 4 weeks prior to randomization
* Patients with clinical symptoms or signs of gastrointestinal obstruction that require parenteral hydration and/or nutrition.
* Patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization.
* Patients with history of hypersensitivity to any of the study drugs or ingredients.
|
NCT_ID
NCT02069704
|
Study_NameBioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients
| 9,874 |
Study Objectives
This will be an open-label, randomised, 2 part (Part A and Part B), 2 treatment (savolitinib alone or in combination with famotidine), crossover study in healthy, non Japanese, male subjects, performed at a single study centre.
Conditions: Solid Tumours
Intervention / Treatment:
DRUG: Savolitinib, DRUG: Famotidine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
|
Inclusion Criteria:
* Provision of signed and dated written informed consent prior to any study specific procedures.
* Healthy, non-Japanese male subjects with suitable veins for cannulation or repeated venipuncture: male subjects aged 18 <= age <= 65 (inclusive).
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive; and weigh at least 50 kg and no more than 100 kg inclusive.
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBL) less than or equal to the upper limit of normal for the institution.
* Have a calculated creatinine clearance greater than 80 mL/min using the Cockcroft-Gault formula at screening.
* Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol.
Exclusion Criteria:
* Subject that has at least 1 parent or grandparent (maternal or paternal) of Japanese ethnicity.
* Subjects who screen positive for Helicobacter pylori bacteria.
* History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
* History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of either study drug (savolitinib or famotidine).
* Planned in-patient surgery, dental procedure, or hospitalisation during the study.
* Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the PI.
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
* Abnormal vital signs, after 5 minutes supine rest, defined as any of the following:
1. Systolic BP <90 mmHg or >=140 mmHg
2. Diastolic BP <50 mmHg or >=90 mmHg
3. Heart rate <45 or >85 beats per minute.
* Any clinically important abnormalities in rhythm, conduction or morphology of the 12 lead resting electrocardiogram (ECG) that may interfere with the interpretation of QTc interval changes. These include healthy subjects with any of the following:
1. Abnormal ST-T-wave morphology, particularly in the protocol-defined primary lead (V2) or left ventricular hypertrophy.
2. PR interval shortening <120 ms (PR >110 ms but <120 ms is acceptable if there is no evidence of ventricular pre-excitation).
3. PR interval prolongation (>200 ms). Intermittent second (Type 1 second degree block [Wenckebach Phenomenon] while asleep is not exclusive]) or third degree atrioventricular (AV) block, or AV dissociation.
4. Persistent or intermittent complete bundle branch block, incomplete bundle branch block, or intraventricular conduction delay with QRS >110 ms. Subjects with QRS >110 ms but <115 ms are acceptable if there is no evidence of eg, ventricular hypertrophy or pre-excitation.
5. Mean resting prolonged QTcF >450 ms or shortened QTcF <340 ms obtained from 3 ECGs.
* A history of additional risk factors for torsades de pointes (TdP) (eg, heart failure, chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years in first-degree relatives).
* Use of any medications known to prolong the QT/QTc interval and cause TdP.
* Use of any prescribed or non prescribed medication including antacids, analgesics (other than ibuprofen up to 72 hours before dosing day), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of either study drug or longer if the medication has a long half life.
* Known or suspected history of drug abuse, as judged by the PI.
* Current smokers or those who have smoked or used nicotine products within the previous 30 days.
* History of alcohol abuse or excessive intake of alcohol as judged by the PI.
* Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the PI.
* Use of drugs with enzyme inducing properties such as St John's Wort, within 3 weeks prior to the first administration of either study drug.
* Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first admission on Day -1.
* Positive screen for drugs of abuse or cotinine (nicotine) or alcohol at screening and before each admission to the Study Centre.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI, or history of hypersensitivity to drugs with a similar chemical structure or class to savolitinib or famotidine.
* Plasma donation within 1 month of screening or any blood donation or loss of >500 mL during the 3 months prior to screening.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of either study drug in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest. Note: subjects consented and screened, but not randomised in this study or a previous Phase I study, are not excluded.
* Subjects who have previously received savolitinib.
* Involvement of any AstraZeneca, Parexel, or study site employee or their close relatives.
* Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
* Subjects who are vegans or vegetarians, or have medical dietary restrictions.
* Subjects who cannot communicate reliably with the PI.
* Vulnerable subjects, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
* In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
* In addition, the following are considered criteria for exclusion from the optional genetic component of the study:
* Previous bone marrow transplant.
* Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection or previous bone marrow transplant.
|
NCT_ID
NCT04179071
|
Study_NameA Study in Healthy Male Subjects to Understand How Savolitinib Behaves Inside the Body (Pharmacokinetics) When Administered Alone and in Combination With Famotidine
| 19,554 |
Study Objectives
The purpose of this multicenter imaging sub study is to evaluate the biodistribution and organ pharmacokinetics of 89Zr-MMOT0530A in patients with unresectable pancreatic or platinum-resistant ovarian cancer. MMOT0530A is a monoclonal antibody that targets an antigen overexpressed in pancreatic and ovarian cancer. Subsequent to imaging with 89Zr-MMOT0530A, patients will be treated with DMOT4039A in the DMO4993g protocol (clinicaltrials.gov identifier NCT01469793) after this study. DMOT4039A is an antibody-drug conjugate composed of the monoclonal antibody MMOT0530A and the mitotic agent monomethyl auristatin (MMAE). By imaging patients with the monoclonal antibody MMOT0530A before treatment, the correlation between tumor uptake of 89Zr-MMOT0530A and response to DMOT4039A therapy will be assessed.
Conditions: Ovarian Neoplasms, Ovarian Diseases, Adnexal Diseases, Pancreatic Neoplasms, Digestive System Neoplasms, Digestive System Diseases, Pancreatic Diseases
Intervention / Treatment:
DRUG: 89Zr-MMOT0530A
Location: Netherlands
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Adult patients, >= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer
* Measureable disease, defined as at least one bi-dimensionally measurable non-lymph node lesion >= 1 cm in long-axis diameter on spiral CT scan or at least one bi-dimensionally measurable lymph node measuring >= 1.5 cm in short-axis diameter on spiral CT scan
* Adequate hematological, renal and liver function
Exclusion criteria:
* Treatment with anti-tumor therapy, including chemotherapy, biologic, experimental or hormonal therapy, within 4 weeks prior to Day 1
* Known active infection
* Current Grade >= 2 toxicity (except for alopecia, anorexia and fatigue) from prior therapy or Grade >= 2 neuropathy
* Untreated or active cerebral nervous system (CNS) metastases
* Pregnant or breastfeeding women
|
NCT_ID
NCT01832116
|
Study_Name89Zr-MMOT PET Imaging in Pancreatic and Ovarian Cancer Patients
| 7,400 |
Study Objectives
This phase II trial studies the effectiveness of ImmunoPulse IL-12® in treating patients with Merkel cell cancer. ImmunoPulse IL-12® is the combination of intratumoral interleukin-12 gene (also known as tavokinogene telseplasmid \[tavo\]) and in vivo electroporation-mediated plasmid deoxyribonucleic acid \[DNA\] vaccine therapy (tavo-EP) administered using the OncoSec Medical System (OMS). Placing the gene for interleukin-12 into Merkel cells may help the mount an effective anti-tumor immune response to kill tumor cells.
Conditions: Merkel Cell Carcinoma
Intervention / Treatment:
BIOLOGICAL: Tavokinogene Telseplasmid (tavo), DEVICE: OncoSec Medical System (OMS)
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:
* Patients must have biopsy-confirmed Merkel cell carcinoma
* Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable intratumoral injection and electroporation; the injectable lesion must not be in close proximity to another tissue (e.g. nerve, bone) that could put patient safety at risk
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2
* Life expectancy of greater than three months
* Absolute neutrophil count > 1,000/uL
* Platelet count > 50,000/uL
* Creatinine =< 2.0 x upper limit of normal (ULN)
* Bilirubin =< 2.0 x ULN
* Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN
* Patients must be willing, at the time of the entry to the study, to undergo the pre-treatment fine needle aspiration (FNA) plus biopsy (if indicated) AND the post-treatment FNA plus biopsy (or surgery) of at least one injected lesion (FNA is essential to determine the primary endpoint of the study); NOTE: The pre-treatment biopsy will be obtained from a superficial not-to-be-injected lesion; the post-treatment biopsy of an injected lesion will be obviated if definitive surgical resection is planned
* The effects of this treatment approach on the developing human fetus are unknown; for this reason, 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 have the ability to understand and the willingness to sign a written informed consent document
* Both men and women, and members of all races and ethnic groups are eligible for this trial
Exclusion Criteria:
* Patients who have had prior chemotherapy, investigational therapy or a major surgical procedure within 4 weeks or radiotherapy within 2 weeks prior to first day of treatment
* Patients must not be receiving concurrently any other anti-cancer treatment (including topical agents such as imiquimod) or investigational agents, which could potentially interfere with the study treatment and/or study endpoints
* Patients with active untreated brain metastases will be excluded
* Pregnant or breast feeding women are excluded because effects of this treatment on the fetus or passage through milk are unknown
* Patients with electronic pacemakers or defibrillators or those with a history of life threatening cardiac arrhythmia or uncontrolled seizure disorder are excluded
* Use of any immunosuppressive treatments including corticosteroids, cyclosporine, mycophenolate mofetil et cetera, within 4 weeks prior to Day 1 of treatment will not be allowed; NOTE: Patients on topical or physiologic doses (for hormone-replacement therapy) of corticosteroids will be allowed
* Patients, who are judged to be immunosuppressed due to uncontrolled human immunodeficiency virus (HIV) infection, severe uncontrolled diabetes, concurrent hematological malignancy, or other comorbidities, will be excluded
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, serious autoimmune conditions or psychiatric illness/social situations that would limit compliance with study requirements
* Patients receiving concurrent therapeutic-dose anticoagulation will be excluded
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NCT_ID
NCT01440816
|
Study_NameIL-12 Gene and in Vivo Electroporation-Mediated Plasmid DNA Vaccine Therapy in Patients With Merkel Cell Cancer
| 10,248 |
Study Objectives
The purpose of the study is to evaluate the safety and potential side effects of everolimus (an experimental drug) on a person with Tuberous Sclerosis Complex who also has been diagnosed with a brain tumor (astrocytoma)
The hypothesis is that the drug will cause the tumor size to decrease, and may have beneficial activity separate from effects on tumors in patients.
Conditions: Tuberous Sclerosis, Subependymal Giant Cell Astrocytoma
Intervention / Treatment:
DRUG: Everolimus
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:
* Age three years and older
* If female and of child bearing potential, documentation of negative pregnancy test prior to enrollment. In the extension phase, all females of child bearing potential will be required to take monthly home pregnancy tests and record results on a provided diary card.
* Clinically definite diagnosis of tuberous sclerosis (modified Gomez criteria or positive genetic test)
* Presence of giant cell astrocytoma as defined by imaging characteristics and serial increase in size of lesion on 2 or more MRI scans
* Adequate renal function (creatinine < 1.5 mg/dl)
Exclusion Criteria:
* Serious intercurrent medical illness or other uncontrolled medical disease which could compromise participation in the study
* Significant hematologic or hepatic abnormality
* Continuous requirement for supplemental oxygen
* Intercurrent infection at initiation of everolimus
* Embolization of angiomyolipoma within one month; any other recent surgery within 2 months of initiation of everolimus
* Pregnant or lactating women
* Use of an investigational drug within the last 30 days
* Must be adequately recovered from the acute toxicities of any prior therapy
* Clinical evidence of impending herniation or focal neurologic deficit related to the subject's astrocytoma
* Unwilling or unable to use highly effective contraception
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NCT_ID
NCT00411619
|
Study_NameEverolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex
| 7,158 |
Study Objectives
This research study is studying the combination of Pegylated Liposomal Doxorubicin (PLD) and Pembrolizumab as a possible treatment for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer that is resistant to platinum therapy.
The following interventions will be used in this study:
* Pegylated liposomal doxorubicin (PLD)
* Pembrolizumab
Conditions: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Intervention / Treatment:
DRUG: Pembrolizumab, DRUG: Pegylated Liposomal Doxorubicin (PLD)
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:
* Be willing and able to provide written informed consent/assent for the trial.
* Be 18 years on day of signing informed consent.
* Have measurable disease based on RECIST 1.1 criteria.
* Have a histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube or peritoneal cancer. All histologies of epithelial ovarian cancer are eligible except for carcinosarcomas.
* Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g., bevacizumab) or extended therapy administered after surgical or non-surgical assessment.
* Patients must have platinum resistant cancer with a platinum free interval of < 6 months. Progression after last platinum is based on investigator assessment.
* Patients are allowed to receive, but are not required to receive, up to two additional cytotoxic regimens for management of recurrent or persistent disease, with no more than 1 non-platinum, non-taxane regimen.
* Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary treatment regimen. For the purposes of this study, Poly (ADP-ribose) polymerase (PARP) inhibitors will be considered "cytotoxic." Patients are allowed to receive, but are not required to receive, PARP inhibitors for management of primary or recurrent/persistent disease (either alone or in combination with cytotoxic chemotherapy). Single agent hormonal therapies will not be counted as a line of treatment.
* Have adequate tissue from an archived specimen of ovarian cancer (between 10 to 15 slides of unstained tumor).
* Have a performance status of 0 or 1 on the ECOG Performance Scale (Appendix A).
* Demonstrate adequate organ function as defined in Table 1, all screening labs must be performed within 10 days of treatment initiation.
Table 1 Adequate Organ Function Laboratory Values
System Laboratory Value
* Hematological
* Absolute neutrophil count (ANC) >=1,500 /mcL
* Platelets >=100,000 / mcL
* Hemoglobin >=9 g/dL or >=5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
* Renal
* Serum creatinine OR
* Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) <=1.5 X upper limit of normal (ULN) OR >=60 mL/min for participant with creatinine levels > 1.5 X institutional ULN
* Hepatic
* Serum total bilirubin <= 1.5 X ULN OR Direct bilirubin <= ULN for participants with total bilirubin levels > 1.5 ULN
* AST (SGOT) and ALT (SGPT) <= 2.5 X ULN OR <= 5 X ULN for participants with liver metastases
* Albumin >2.5 mg/dL
* Coagulation
* International Normalized Ratio (INR) or Prothrombin Time (PT)
* Activated Partial Thromboplastin Time (aPTT) <=1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants <=1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance should be calculated per institutional standard.
* Female participants of childbearing potential must have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
Exclusion Criteria:
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
* Patients cannot have primary platinum refractory cancer, i.e. documented cancer progression while receiving platinum or within one month of receipt of a platinum based regimen.
* Has received a prior anthracycline chemotherapy either for ovarian cancer treatment or another previous malignancy.
* Left ventricular ejection fraction (LVEF) defined by multigated acquisition (MUGA) or echocardiogram which is below the institutional lower limit of normal prior to starting study treatment.
* Has a known history of active TB (Bacillus Tuberculosis)
* Hypersensitivity to pembrolizumab or any of its excipients and/or liposomal doxorubicin.
* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent.
* Note: Participants with < Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
* Note: If participant underwent major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
* Has a known additional malignancy that is progressing or requires active treatment. In addition, patients cannot have been diagnosed with another malignancy within 3 years of starting treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include clinically active and significant carcinomatous meningitis which is excluded regardless of clinical stability.
* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has known history of, or any evidence of active, non-infectious pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
* Has received a live vaccine within 30 days of planned start of study therapy.
* Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
|
NCT_ID
NCT02865811
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Study_NamePembrolizumab Combined With PLD For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer
| 19,492 |
Study Objectives
This project involves looking at the timing of providing pain relief for patients who are having lung surgery via the use of a small camera inserted into the chest with a scope (Video assisted thorascopy). This procedure can be the source of intense pain both immediately after the procedure and in the longer term leading to chronic pain problems.
Local anaesthetic placed in the paravertebral space which is located adjacent to the spinal column, where the pain nerve fibres are located, is a well recognized method of providing pain relief for these procedures. It is currently unclear as to the best timings for providing this type of pain relief with some centres placing the local anaesthetic at the start of the procedure and some at the end. Placing a high volume of local anaesthetic into this area at the start of the case may provide better short and long term pain relief than placing it at the end of the procedure. The investigators hope to show a difference between the two timings to allow for better pain relief for these procedures. This would be a feasibility study that would lead onto a multicentre trial to eventually create a best practice protocol for pain relief for lung resection via this surgical method.
Conditions: Lung Tumour, Lung Metastases
Intervention / Treatment:
PROCEDURE: Early paravertebral block, PROCEDURE: Late Paravertebral block.
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
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Inclusion Criteria:
* Subjects will be recruited from patients admitted for elective VATS for lung resection.
* Patients aged 18 and over.
* Patient's will be ASA 1,2 or 3.
Exclusion Criteria:
* Patient refusal.
* Emergency surgery.
* Patient unable to provide consent.
* Infection in paravertebral space.
* Patients who attend a chronic pain clinic on high doses of opiate drugs.
* History of Anaphylaxis/allergy to local anaesthetic.
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NCT_ID
NCT01621698
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Study_NameStudy of Use of Paravertebral Blocks for Pain Relief in Video Assisted Lung Surgery
| 20,932 |
Study Objectives
Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without oxaliplatin in treating patients who have stage II or stage III colon cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for colon cancer
Conditions: Stage II Colon Cancer, Stage III Colon Cancer
Intervention / Treatment:
DRUG: leucovorin calcium, DRUG: fluorouracil, DRUG: oxaliplatin, OTHER: laboratory biomarker analysis
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 must consent to be in the study and must have signed and dated an IRB-approved consent form conforming to federal and institutional guidelines
* In the opinion of the investigator, patients must have a 10-year life expectancy, excluding their diagnosis of cancer
* The interval between curative resection and randomization must be no more than 42 days
* The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy
* Patients must have colonic adenocarcinoma that meets one of the criteria below:
* Stage II carcinoma (T3, 4; N0; M0) - The tumor invades through the muscularis propria into the subserosa, or into non-peritonealized pericolic or perirectal tissues (T3) or directly invades other organs or structures, and/or perforates visceral peritoneum (T4), excluding free perforation
* Stage III carcinoma (any T; N1, 2; M0) - The tumor has invaded to any depth, with involvement of regional lymph nodes
* AGCs >= 1500/mm^3
* Platelets >= 100,000/mm^3
* Bilirubin within or below the normal limits for the laboratory
* Alkaline phosphatase within or below the normal limits for the laboratory
* SGOT or SGPT within or below the normal limits for the laboratory
* Serum creatinine within or below the normal limits for the laboratory
* Patients with more than one synchronous primary colon tumor are eligible; for the purpose of this protocol, staging classification will be based on the stage of the more advanced primary tumor
* Patients are eligible if adjacent structures (e.g., bladder, small intestine, ovary, etc.) involved by direct extension of the primary tumor are removed en bloc and if, in the judgement of the surgeon and by confirmation on histological examination (i.e., margins of resection are not involved), the resection is deemed to be "curative"
* Patients must have an ECOG performance status of 0, 1, or 2
* Patients with intestinal obstruction are eligible; preliminary or complementary colostomy does not preclude entry
* Patients with prior noncolorectal malignancies are eligible if they have been disease-free for >= 5 years; patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by operation only, or lobular carcinoma in situ of the breast are eligible, even if these conditions were diagnosed within 5 years prior to randomization
Exclusion Criteria:
* Prior invasive colon or rectal malignancy, regardless of disease-free interval
* Current or past malignant colon tumors other than carcinoma, i.e., sarcoma, lymphoma, carcinoid, etc., regardless of disease-free interval
* Tumors located < 12 cm from the anal verge on preoperative endoscopy
* Tumors that demonstrate free perforation as manifested by free air or free fluid in the abdomen; patients with walled-off perforation are eligible
* Pregnancy or lactation at the time of proposed randomization; (5-FU and oxaliplatin are both teratogenic and mutagenic and may cause fetal harm;) eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods
* Noncurative surgical resection or prior chemotherapy or radiotherapy for this malignancy, with the exception of a decompressing colostomy
* Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient's receiving either chemotherapy treatment option; specifically excluded are patients with active ischemic heart disease (class III or class IV myocardial disease -- New York Heart Association) or a recent history of myocardial infarction (within 6 months), or current symptomatic arrhythmia
* Class III: Patients with cardiac disease resulting in marked limitation of physical activity; such patients are comfortable at rest; less-than-ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain
* Class IV: Patients with cardiac disease resulting in inability to perform any physical activity without discomfort; symptoms of cardiac insufficiency or the anginal syndrome may be present even at rest
* Psychiatric or addictive disorders that would preclude obtaining informed consent
* Multiple primary tumors involving both the colon and the rectum that would preclude the patient's being classified as having only colon cancer
* Evidence of laparoscopically-assisted colectomy, unless patients are participating in the Intergroup Protocol INT 0146 or the Australasian, Multi-center, Prospective, Randomized, Clinical Study Comparing Laparoscopic and Conventional Open Surgical Treatments of Colon Cancer in Adults (ALCCaS)
* Isolated, distant, or noncontiguous intra-abdominal metastases, even if resected, will render the patient ineligible
* Clinically significant peripheral neuropathy at the time of randomization (defined in the NCI Common Toxicity Criteria [CTC] as grade 2 or greater neurosensory or neuromotor toxicity)
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NCT_ID
NCT00004931
|
Study_NameFluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer
| 14,589 |
Study Objectives
Patients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg before induction of spinal anesthesia.. During the surgery, blood pressure and heart rate were monitored. Postoperative analgesia was provided by a PCA morphine. Acute postoperative pain was assessed by a visual analog scale. The incidence of postoperative neuropathic pain was detected by the DN4 questionnaire after one and three months of surgery.
Conditions: Chronic Pain Following Surgical Procedure for Cancer
Intervention / Treatment:
OTHER: Gabapentin versus Ketamine
Location: Tunisia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE
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Inclusion Criteria:
* ASA I and II
* Inguinal Hernia Repair in non emergent conditions
Exclusion Criteria:
* Patients with significant cardiovascular central nervous system disease, renal or liver failure could not operate the PCA device
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NCT_ID
NCT04700592
|
Study_NameA Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair
| 5,423 |
Study Objectives
High-dose chemotherapy (HD-CT) is able to circumvent platinum-resistance of resistant/refractory germ-cell tumors (GCTs), but expectancy of cure remains low. New strategies are needed with new drugs and a sequential approach.
Patients with relapsed (but not absolutely refractory to Cisplatinum-based chemotherapy) poor-prognosis GCTs are scheduled to receive 2 cycles combining epirubicin and paclitaxel followed by 3 consecutive HD-CT supported by stem cell transplantation. One course will combine Taxol, 360 mg/m² + thiotepa, 720 mg/m², followed by two ICE regimens (Ifosfamide, 12 g/m², carboplatin, AUC 20, etoposide, 1500 mg/m²).
This phase II study is designed as a Gehan method. The main objective of the study is the complete response rate. With this aim in view, it is planned to enroll in its first step 14 patients to insure that if no complete response (CR) is noticed, study would be stopped for inefficacy (i.e., a CR rate lower than 20%). If one or more CR are noticed, protocol specified that up to 45 patients will be included in order to reduce the confidence interval (CI) of the CR rate. Secondary objectives are the overall response rate (RR), the overall survival (OS) and the progression-free survival (PFS) rates, toxicity and toxic death rate. The statistical analysis is done in terms of intent-to-treat.
Conditions: Testicular Neoplasms
Intervention / Treatment:
DRUG: epirubicin, PROCEDURE: high-dose and autologous stem cell transplantation, DRUG: paclitaxel, DRUG: etoposide, DRUG: ifosfamide, DRUG: carboplatin
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
Eligibility requirements includes the following criteria:
* Age >18 years and < 65
* Performance status < 3
* Histologically or biologically documented GCTs
* Testicular, abdominal, or mediastinal tumors
* Measurable or evaluable disease
* Life expectancy > 3 months
* Normal cardiac, liver, and renal function tests
* Absence of infection
* HIV negative test
* Signed informed consent
* All patients had to have been previously treated with at least one line of a cisplatin-containing regimen and were included if they were refractory after one or two line(s) of cisplatin-based CT, or had relapsed after two lines of a cisplatin-based CT
Exclusion Criteria:
* Fireproof diseases (progress unless month with regard to the last cycle of chemotherapy or in the course of chemotherapy)
* Relapses after complete answer obtained by surgery ( sCR )
* Neuropathy of superior rank or = II - renal Function (Office) superior creatinine or = 125 mmol/l and/or clearance of the creatinine subordinate or = II 60ml / mn
* Antecedents of congestive even compensated cardiac insufficiency
* Hurts of growing teratoma that is measurable hurts increasing by size (cutting) in the absence of rise of marker pens
* Extensive chemotherapy with support of haematopoietic stem cells. NB: A previous preventive irradiation under diaphragmatitis for a seminoma stage I (dose from 24 to 30 Gy in classic spreading) does not establish one against formal indication. However, an estimation clarifies capacities of the haematopoietic marrow is recommended with observation of the evolution of the NFP in the course of chemotherapy and quantification of cells CD 34 + in the peripheral blood. It's the same of the case where a chemotherapy by carboplatine was realized
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NCT_ID
NCT00231582
|
Study_NameHigh-dose Chemotherapy With Autologous Stem Cell Transplantation in Poor Prognosis Germ-cell Tumors: TAXIF II
| 2,049 |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving fluorouracil into the liver is more effective than no further treatment for patients with colon cancer undergoing surgery.
PURPOSE: This randomized phase III trial is studying giving infusions of fluorouracil into the liver in treating patients with Dukes' A, Dukes' B, or Dukes' C colon cancer undergoing surgery.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: fluorouracil, OTHER: Observation, DRUG: sodium heparin
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* more than one synchronous primary colon tumor
* white blood cell (WBC) > 4000/cu.mm. and platelet count greater than or equal to 100,000/cu.mm.
* evidence of adequate renal (serum creatinine less than or equal to 1.5 mg%) and hepatic function (bilirubin less than or equal to 1.5 mg%; serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 60 I.U./ml)
* performance status of 0, 1 or 2
* Patients with intestinal obstruction are eligible. Preliminary or complementary colostomy does not preclude entry of a patient provided randomization is carried out prior to the planned curative resection.
* The distal margin of the tumor must be greater than or equal to 12 cm from the anal verge as endoscopically measured with the patient in the knee-chest position.
* Carcinoembryonic antigen (CEA) must be performed pre-operatively but results need not be known at the time of randomization.
Exclusion criteria:
* malignant colon tumors other than carcinoma, i.e., sarcoma, lymphoma, etc.
* patients whose tumors demonstrate free perforation
* previous or concomitant malignancy, regardless of site - except patients with squamous or basal cell carcinoma of the skin, and carcinoma in situ of the cervix which have been adequately treated
* patients who have received prior treatment other than preliminary or complementary colostomy (radiation, chemotherapy or surgery) for their current malignancy.
* patients having tumors within 12 cm of the anal verge
* performance status of 3 or 4
* patients having non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) which would preclude their being subject to the chemotherapy treatment option
* patients who are pregnant at the time of randomization
* patients with psychiatric or addictive disorders which would preclude obtaining informed consent
* patients who have multiple primary tumors involving both the colon and the rectum which would preclude them from being classified as having only colon cancer or only rectal cancer
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NCT_ID
NCT00427310
|
Study_NameLiver Infusions of Fluorouracil in Treating Patients With Dukes' A, Dukes' B, or Dukes' C Colon Cancer Undergoing Surgery
| 13,168 |
Study Objectives
The aim of the study is to determine the effect and safety of topical rapamycin or calcitriol and their combination for the treatment of TSC-associated facial angiofibroma.
Methods: A total of 52 TSC patients including 20 male and 32 female subjects were recruited, and 50 of them completed the period 1 study. In period 1, topical rapamycin (0.1%) or calcitriol (3 mcg/g) single-agent therapy versus their combination were applied twice a day by a left-right randomized, split-face comparison for 12 weeks. The primary end point was the reduction of facial angiofibroma severity index (FASI) for the grade of erythema, papule size, elevation and extension of the lesions at week 12. In period 2, the patients entered an open-label study and were reassigned to use the more effective ointment on both cheeks for another 12 weeks (week 13-24). A follow-up FASI analysis for recurrence after drug discontinuance for 12 weeks was also performed (week 36). The secondary end point was the reduction of Visual Analysis Score (VAS) evaluated by the subjects themselves at week 12.
Conditions: Facial Angiofibroma
Intervention / Treatment:
DRUG: Rapamycin, DRUG: Calcitriol, DRUG: Rapamycin-calcitriol combination
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
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Inclusion Criteria:
* Subjects must have been diagnosed or highly suspected as having TSC.
* Subjects must be aged 7 <= age <= 70 at Screening, and can be either sex.
* Subjects must have symmetric facial angiofibromas.
Exclusion Criteria:
* Pregnancy or with a plan to be pregnant.
* Subjects who cannot comply the treatment protocol.
* Subjects with kidney or liver/ biliary dysfunction.
* Subjects with hypercalcaemia and patients known to suffer from abnormal calcium metabolism.
* Subjects on systemic treatment of calcium deficiency.
* Subjects known to be hypersensitive to rapamycin or calcitriol.
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NCT_ID
NCT03140449
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Study_NameTopical Rapamycin and Calcitriol for Angiofibroma of Tuberous Sclerosis
| 11,835 |
Study Objectives
The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade (infliximab) monoclonal antibodies in the early posttransplant period followed by either monotherapy based on tacrolimus or sirolimus.
Conditions: Kidney Transplantation
Intervention / Treatment:
DRUG: MabCampath,, DRUG: Remicade, DRUG: Sirolimus, DRUG: Tacrolimus
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion criteria:
* First deceased-donor kidney transplantation
* Age >18 years
* Donor <65 years
* Cytomegalovirus (CMV)/ Epstein-Barr virus (EBV) seropositivity
* panel reactive antibodies (PRA) <10%
* Written consent
Exclusion criteria:
* Retransplantation, combined transplantation
* Prior immunosuppression less than 6 months prior transplantation
* Induction therapy with antibodies
* Leukopenia < 4000, thrombocytopenia < 100 000, Haemoglobin < 80 g/l
* History of antithymoglobulin (ATG) or anti-cluster of differentiation 3 (CD3) monoclonals or anti-TNF-α
* Tuberculosis history
* Anti-hepatitis C virus (HCV) positivity, HBsAg
* HIV positivity
* Malignancy history
* Allergy to study medication
* Fertile women without contraception
* Pregnancy, breastfeeding mothers
|
NCT_ID
NCT02711202
|
Study_NameSequential Targeting of Cluster of Differentiation 52 (CD52) and Tumor Necrosis Factor (TNF) Allows Early Minimization Therapy in Kidney Transplantation
| 16,371 |
Study Objectives
Phase II, open label study in which patients with metastatic melanoma (stage III or IV) who have cancer which is not considered curable by surgery will receive intratumoral injections of TNFerade™ plus radiation as a 4-week treatment, followed by a 3 year follow-up period.
Conditions: Melanoma
Intervention / Treatment:
DRUG: TNFerade™
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
|
Inclusion Criteria:
* Patient must be 18 years or older, and able to give informed consent.
* Patients with metastatic melanoma (AJCC stage III or IV) who are not eligible for curative surgery and who are candidates for experimental therapy. Eligible patients will include those with melanoma involving the regional lymph nodes and surrounding tissues as well as those with unresectable cutaneous, subcutaneous, nodal or soft tissue metastases.
* Patients must have one or more tumor nodules accessible for direct injection.
* Patients with metastases outside the treatment field may be enrolled if the sites of metastases do not limit survival expectancy to less than 3 months.
* Patients must be unlikely to derive significant potential benefit from other treatment options and no other treatments should be anticipated during the study treatment period or a period of two months thereafter.
* Patient's Karnofsky performance status must be greater than or equal to 70%.
Exclusion Criteria:
* Chemotherapy or experimental medications within the last four weeks prior to Day 1.
* Active disease of the central nervous system.
* Baseline liver enzymes (AST, ALT, bilirubin, alkaline phosphatase) greater than 3 times the upper limit normal.
* Renal insufficiency (Serum creatinine greater than 2.0 mg/dL).
* Coagulopathy (PT INR >1.5 or PTT ratio >1.5 in patients not receiving anticoagulants).
* Significant anemia (e.g. hematocrit <28% or hemoglobin <9 g/dL). May have RBC transfusion, or thrombocytopenia (platelet count less than 100,000/μl); or leukopenia (WBC <3000/μl; ANC <1500/μl).
* Patients with documented history of deep venous thrombosis, pulmonary embolus, cerebrovascular disease, stroke, or TIA.
* Patients with history of coagulopathy or known thrombophillic disorders.
* Clinical evidence of active infection of any type, including hepatitis B or C virus.
* Pregnant or lactating women. It is recommended that both men and women use condoms or another barrier method of birth control for at least 2 months following the last administration of TNFerade™ biologic and some form of birth control for at least 1 year.
* Significant concurrent medical or psychiatric illness which, in the opinion of the investigator, would interfere with the patient's ability to participate in the trial
* Chronic systemic corticosteroid use, orally or parenterally administered.
* Known sensitivity to lidocaine, procaine or amide local anesthetics (used for topical anesthesia).
* Surgery within the last 4 weeks prior to day 1 (if patient was ambulatory within 48 hours of surgery, patient may be considered eligible)
* Attempted resection of the tumor to be treated, or surgery on the area to be treated, with incomplete healing of surgical wound. (If the surgical wounds are completely healed and lesion continues to progress, patient may be enrolled.)
* Patients with a history of clinical lymphedema in the area to be treated.
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NCT_ID
NCT00261404
|
Study_NameTNFerade™ Biologic Plus Radiation for Metastatic Melanoma
| 9,208 |
Study Objectives
Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin. Thalidomide has been available for many years and has been used to treat many different illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have blood vessels providing oxygen and nutrients, it will not be able to grow. This research will look at how combining the effects of thalidomide (preventing tumor growth) with the tumor killing effect of carboplatin effects the long-term outlook for patients with these tumors.
This study will try to find out how well Thalomid™ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. This study will look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem glioma. This study will also look at any side effects of these treatments.
Conditions: Brain Stem Neoplasms, Primary, Neoplasms, Brain Stem
Intervention / Treatment:
DRUG: Carboplatin, DRUG: Thalomid, PROCEDURE: External Beam Radiation Therapy
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:
* Patients must be >= 3 and <= 21 years.
* Patients must have a newly diagnosed or progressive brain stem tumor.
* If biopsy has been performed, patients with both high and low grade astrocytomas are eligible.
* Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic confirmation of brain stem glioma is mandatory for study entry.
* Cervicomedullary junction tumors are ineligible.
* Patients with a diagnosis of NF-1 are ineligible.
* Patients must be registered within 6 weeks from diagnosis or recurrence.
* Patients must have life expectancy > 6 weeks.
* Patients must have adequate hematologic and renal function: ANC >1,000/ul, platelets>100,000/ul and creatinine normal for age: <= 0.7 mg/dl (age 3 <= age <= 10yrs.), <= 1.0 mg/dl (11 <= age <= 12yrs.). and <= 1.2 (13 <= age <= 21yrs.).
* Written informed consent must be obtained according to institutional guidelines.
* Pregnant or nursing women are ineligible.
* Patients must be registered within 3 days prior to the start of protocol treatment. Patients must not start treatment until informed consent is given and the patient is registered. Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program.
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NCT_ID
NCT00179881
|
Study_NameThalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
| 14,075 |
Study Objectives
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: exemestane
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
|
Inclusion Criteria:
* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion Criteria:
* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to exemestane or any comparable or similar product.
|
NCT_ID
NCT01331421
|
Study_NameBioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions
| 16,646 |
Study Objectives
The investigators hypothesize that prophylactic E-selectin inhibition via administration of uproleselan during melphalan conditioning will reduce the gastrointestinal (GI) toxicity in multiple myeloma (MM) patients undergoing auto-transplant, as assessed via diarrhea severity scoring per CTCAE v5.0, while potentially increasing chemosensitivity of malignant MM cells to high-dose melphalan.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Uproleselan, DRUG: Placebo, DRUG: Melphalan
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Biopsy-confirmed multiple myeloma (MM) (per IMWG criteria).
* Undergoing first auto-HCT for MM in first partial response (PR) or better
* Conditioning regimen to be single agent melphalan (200 mg/m^2)
* Adults 18 <= age <= 75 of age, inclusive
* ECOG performance status <= 2
* Mobilized >= 5.0 x 10^6 CD34+ cells/kg (i.e. sufficient CD34+ HSCs for one auto-HCT, with at least one back-up graft in reserve)
* Adequate bone marrow and organ function prior to stem cell mobilization as defined below:
* Leukocytes, absolute neutrophil count, and platelets within institutional standard limits for high-dose melphalan autologous stem cell transplant
* Total bilirubin <= 1.5 x ULN (unless the patient has a history of Gilbert's Syndrome, in which case, total bilirubin must be <= 2.5 times the ULN)
* AST(SGOT)/ALT(SGPT) <= 3.0 x ULN
* Creatinine clearance >= 30 mL/min by Cockcroft-Gault
* Baseline pulmonary function test (PFT) with carbon monoxide diffusion capacity in the lung (DLCO) >= 50% and forced expiratory volume in 1 second (FEV1) both within institutional standard limits for high-dose melphalan autologous stem cell transplant
* The effects of uproleselan (GMI-1271) 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 sterilization procedure, abstinence, etc.) prior to study entry, for the duration of study participation and for 12 weeks after the completion of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Should a man who is participating in the study become aware that he has impregnated a partner, he must inform his treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
* A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
* Active signs or symptoms of CNS involvement by malignancy (lumbar puncture not required). Prior history of CNS involvement is acceptable, if patient has completed treatment for CNS involvement with documented treatment response.
* Prior exposure to uproleselan (GMI-1271)
* Currently receiving any other investigational agents
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to uproleselan or melphalan
* Known active infection with hepatitis A, B (e.g., HBsAg positive), or C (e.g., anti-HCV positive), or human immunodeficiency virus
* Uncontrolled acute life-threatening bacterial, viral, or fungal infection-Myocardial infarction within 6 months of uproleselan/placebo dosing, or subject has current significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hemodynamic instability, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
* Any medical, psychiatric, or other condition which, in the opinion of the investigator, unfavorably alters the risk-benefit of subject participation, is likely to interfere with trial completion, assessments, or interpretation of trial results, or otherwise would make the subject an inappropriate subject for this trial.
* Pregnant and/or breastfeeding.
* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during the trial and for 12 weeks following the last dose of uproleselan/placebo. Women who are postmenopausal with amenorrhea for at least 1 year prior to trial entry and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status (>28U/L) will be considered NOT of childbearing potential. Highly effective contraception includes:
* Total abstinence with a male partner.
* Female sterilization (has had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before uproleselan/placebo. In case of oophorectomy alone, the subject would be eligible only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
* Male sterilization (at least 6 months prior to Screening). For female subjects on the trial, the vasectomized male partner should be the sole partner for that subject.
* BOTH of the following forms of contraception consistently used together:
* Injected, transdermal, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%) with the exception of intrauterine devices, which are excluded due to the risk of infection and bleeding.
* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with or without spermicidal foam/gel/film/cream/vaginal suppository.
* Men who are sexually active and not willing to use condoms during the trial and for 12 weeks following the last dose of uproleselan/placebo, unless they have undergone vasectomy for sterilization (at least 6 months prior to Screening), are excluded from trial participation.
* Men who are sexually active and not willing to use condoms during the trial and for 12 weeks following the last dose of uproleselan/placebo, unless they have undergone vasectomy for sterilization (at least 6 months prior to Screening), are excluded from trial participation.
|
NCT_ID
NCT04682405
|
Study_NameUproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)
| 20,445 |
Study Objectives
Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like substance.
The investigators are studying the effects (good or bad) of adding samarium (a radioactive substance) to the cement that is injected into the induced cavity.
Conditions: Cancer, Metastasis, Pain
Intervention / Treatment:
DRUG: Samarium (153SM)
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:
* The patient must be 18 years or older
* The patient must have histologically proven malignancy in the primary site (breast, prostate, or lung)
* The patient must have a radiographic evidence of bone metastasis, and this must have been performed within 8 weeks prior to enrollment in the study. Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans, magnetic resonance imaging, and PET-CT scans.
* The patient must have an intact anterior wall of spinal canal
* The patient must have significant pain (score 6 or above,)which appears to be related to the radiographically documented metastatic vertebra(e) in concern, as measured by the "Visual Analog Scale"
* The patient must be surgically and medically accepted for vertebroplasty/kyphoplasty operation
* Karnofsky Performance status >40
* Expected life expectancy of 6 months or greater, as estimated by the physician in charge.
* The patient must sign a study specific informed consent prior to enrollment
Exclusion Criteria:
* Epidural soft tissue component
* Patients with vertebral metastases and with clinical or radiographic evidence of spinal cord or cauda equina impingement (effacement) or compression
* Inability to undergo anesthesia
* Hematologic primary malignancies Patients received systemic radiotherapy (89SR or 153SM)within 30 days prior to enrollmen
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NCT_ID
NCT00374751
|
Study_NameEffect of Samarium on the Relief of Pain Due to Vertebral Metastases
| 21,918 |
Study Objectives
The purpose of this study is to determine safety and effectiveness of experimental medication BMS-986205 in combination with Nivolumab in patients with cancers that are advanced or have spread.
Conditions: Advanced Cancer
Intervention / Treatment:
DRUG: BMS-986205, BIOLOGICAL: Nivolumab
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Participants must have histologic or cytological confirmation of a solid tumor that is advanced with measureable disease per RECIST v1.1
* Participants must have received, and then progressed or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting
* Participants must have an ECOG performance status of less than or equal to 1
* Participants must have at least 1 lesion with measurable disease as defined by RECIST Version 1.1
Exclusion Criteria:
* Participants must not have suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease
* Participants with prior exposure to anti PD-1 or anti-PDL1 therapy
* Participants must not have a history of allergy to any of the study treatment components
|
NCT_ID
NCT03792750
|
Study_NameA Study of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors
| 14,486 |
Study Objectives
The proposed study is designed to combine crenolanib with standard salvage chemotherapy to treat patients with R/R AML irrespective the FLT3 status.
Conditions: Relapsed/Refractory Acute Myeloid Leukemia (AML)
Intervention / Treatment:
DRUG: Crenolanib, DRUG: Mitoxantrone, DRUG: Cytarabine, DRUG: Etoposide, DRUG: Fludarabine, DRUG: G-CSF, DRUG: Idarubicin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria
* Confirmed diagnosis of AML, including treatment-related secondary AML (except prior MDS) according to World Health Organization (WHO) 2008 classification at treating institution
* Subjects who are refractory* or who have relapsed** following first line AML therapy with cytarabine/anthracycline based chemotherapy, with or without a tyrosine kinase inhibitor. *Refractory to induction therapy is defined as never achieving CR, CRi or CRp (according to International Working Group criteria) after one line of intensive regimen for AML (re-induction, consolidation and/or transplant allowed) including at least one cytarabine containing induction block with a total dose no less than 700mg/m² per cycle and 3 days of an anthracycline with or without a TKI.
or
**First relapse is defined as untreated hematologic relapse (according to International Working Group criteria) after one line of intensive regimen for AML (re-induction, consolidation and/or transplant allowed) including at least one cytarabine containing induction block with a total dose no less than 700mg/m² per cycle and 3 days of an anthracycline with or without a TKI that induced a CR/CRi/CRp. Subjects are allowed to receive induction, consolidation, transplant and/or maintenance prior to achieving their first CR/CRi/CRp.
* Subjects considered eligible for intensive chemotherapy
* ECOG performance status <= 2
* Age >= 18 years
* Adequate liver function within 72 hours of enrollment, defined as:
* Normal total serum bilirubin
* ALT and AST <= 2.0 x ULN
* Adequate renal function, defined as serum creatinine <= 1.5x ULN
* Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 72 hours prior to enrollment "Woman of childbearing potential" is defined as any woman who has not undergone a hysterectomy and who has had menses at any time in the preceding 24 consecutive months
* Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy) while on crenolanib and for 3 months following the last dose of crenolanib. Hormonal contraception alone is not an acceptable method of birth control for the purpose of this trial.
* Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 3 month after the last dose of crenolanib).
* Willing to adhere to protocol specific requirements 12. Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out. 13. Clinically significant toxic effects of prior therapy (expect hydroxyuria) resolved to Grade <= 1 before the start of study.
Exclusion Criteria
* < 5% blasts in blood or marrow at screening, except if measurable extramedullary AML is confirmed
* Acute promyelocytic leukemia (APL)
* Known clinically active CNS leukemia
* Clinically active or unstable graft-versus-host disease (GvHD) requiring treatment which precludes administration of chemotherapy as defined in this protocol
* Prior anti-leukemia therapy within 14 days of enrollment for classical cytotoxic agents, and within 5x the half-life for other investigational agents
* Prior use of hydroxyurea or isolated doses of cytarabine for palliation (i.e., control of WBC) are allowed but should be discontinued at least 24 hrs prior to enrollment.
* Other agents used strictly with palliative intent might be allowed during this period after discussing with principal investigator
* Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
* Known HIV infection.
* Evidence of ongoing, uncontrolled systemic infection or an uncontrolled local infection requiring therapy at the start of study.
* "Currently active" second malignancy (other than non-melanoma skin cancer, carcinoma in situ of the cervix or prostatic intraepithelial neoplasia within 1 year). Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within 1 year.
* Concurrent participation in another therapeutic clinical trial.
* Pregnant or breastfeeding women
* Subjects of childbearing potential not willing to use adequate contraception during study and 3 months after last dose of crenolanib
* Subject with uncontrolled cardiac disease including congestive heart failure class III or IV by the NYHA, unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
* Subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
* Inability to give an informed consent
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NCT_ID
NCT02626338
|
Study_NamePilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML
| 14,257 |
Study Objectives
Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.
Conditions: Head and Neck Cancer, Lung Cancer, Lymphoma
Intervention / Treatment:
DRUG: Amifostine administered subcutaneously
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: PREVENTION
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Institutional criteria for administration of amifostine
* Radiation therapy
* ECOG PS of at least 2
* No distant mets
* Granulocyte count greater than 2000
* Platelet count greater than 100,000
* Creatinine less than 2.0
Exclusion Criteria:
* Allergy to amifostine
* Life expectancy less than 6 mos
* Investigational drug within last 4 weeks
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NCT_ID
NCT00158041
|
Study_NameSubcutaneous Amifostine Safety Study
| 6,616 |
Study Objectives
This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.
Conditions: Colorectal Cancer, Polyps, Adenomas
Intervention / Treatment:
DRUG: Aspirin, DRUG: Folate
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: DOUBLE
|
Inclusion Criteria:
* One neoplastic polyp removed within three months of study entry or within 16 months of study entry if over 1 cm in size or if subject has had a lifetime history of at least two polyps, with the entire large bowel seen by colonoscopy to be free of further polyps within 3 months of entry.
* An ability and willingness to follow the study protocol, as indicated by the subject's giving informed consent to participate.
* Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
* Anticipated colonoscopic follow-up three years after the qualifying colonoscopy.
* Age between 21 and 80 years at the time of the intake colonoscopy.
* For women of childbearing potential, agreement to use effective birth control for the duration of the study.
* Intent not to take aspirin or aspirin-containing products, NSAIDs or folic acid for the length of the study unless required by a physician.
* Not randomized previously or currently in a chemoprevention trial, except for the: "Nutritional Prevention of Large Bowel Polyps" Study (Polyps Prevention Study I); and brief participation in the "VA Cooperative Study" with no continuing involvement.
Exclusion Criteria:
* Invasive carcinoma in any colonic polyp removed.
* Familial colonic polyposis syndromes.
* Ulcerative colitis or Crohn's disease.
* Malabsorption syndrome (e.g. pancreatic insufficiency).
* Large bowel resection for any reason.
* Diagnosed narcotic or alcohol dependence
* Contraindication to aspirin use, including:
1. documented peptic ulcer disease in the past 20 years
2. aspirin sensitivity
3. bleeding diathesis, including hemorrhagic stroke
* Likelihood of NSAID use
1. recurring arthritis or other musculo-skeletal problems
2. frequent NSAID use in 5 years preceding
3. history of stroke or TIAs
4. history of angina or myocardial infarction
5. desire to take aspirin for the prevention of cardiovascular disease
* Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
* Pregnancy or lactation.
|
NCT_ID
NCT00272324
|
Study_NameAspirin/Folate Prevention of Large Bowel Polyps
| 8,120 |
Study Objectives
In this multi-center phase III trial, untreated patients diagnosed with AL who are not candidates for stem cell transplant with melphalan 200 mg/m2 are the target population. Stage I and II patients will be eligible. Stage III patients will be enrolled in an ancillary phase II study. Eligible patients will be stratified as cardiac stage I or stage II and then randomized to receive MDex or BMDex.
Primary objective is to compare hematologic(clonal) response i.e. the rate of complete response (CR) + partial response (PR) defined according to the criteria of the International Society for Amyloidosis consensus.
Conditions: AL Amyloidosis
Intervention / Treatment:
DRUG: BMDex
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histologic diagnosis of amyloidosis.
* Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis or immunohistochemistry of amyloid deposits must provide clear evidence of kappa or lambda light chains in those who present with peripheral neuropathy or heart as the dominant organ involvement.
* Not eligible for ASCT with melphalan 200 mg/m2. Patients who are eligible for SCT with melphalan 200 mg/m2 but decline the procedure, can be enrolled in the study, but are stratified in a separate stratum before randomization.
* Patients must be 18 years.
* ECOG performance status 0,1 or 2.
* Measurable disease; al least one of the following criteria:
* monoclonal protein >10 g/L in serum,
* amyloid-forming (involved) FLC >75 mg/L with an abnormal K/L ratio,
* difference between involved and uninvolved FLC >50 mg/L,
* bone marrow with a clonal predominance.
* Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system). Definition of organ involvement is defined.
* Hemoglobin >=11 g/dL, absolute neutrophil count >=1500/mikroL, platelets >=140,000/mikroL.
* Total bilirubin <2.5 mg/dL, alkaline phosphatase <5 × u.l.n., ALT <3 × u.l.n..
* Estimated glomerular filtration rate (eGFR) by the MDRD formula >30 ml/min.
* Only patients who are informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional, national and European guidelines are eligible to participate.
* Women must be either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
* Men must agree to use an acceptable method for contraception for the duration of the study.
Exclusion Criteria:
* Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.
* Isolated soft tissue involvement.
* Presence of non-AL amyloidosis.
* Previous treatment for plasma cell disease. A single previous cycle of dexamethasone or steroid equivalent (maximum cumulative dexamethasone dose 160 mg) is allowed; in this case baseline data must be obtained after steroid administration. Previous stem cell harvest is allowed, provided that mobilization is performed with G-CSF only.
* Bone marrow plasma cells >30%.
* Cardiac stage III disease: both cTnT > 0.035 ng/mL (or in place of cTnT the cTnI > 0.10 ng/mL) AND simultaneous NT-proBNP >332 ng/L. These subject can be enrolled in the ancillary phase II study.
* Repetitive ventricular arrhythmias on 24h Holter ECG in spite of anti-arrhythmic treatment.
* Chronic atrial fibrillation
* Supine systolic blood pressure <100 mmHg or symptomatic orthostatic hypotension or clinically important autonomic disease
* Grade 3 sensory or grade 1 painful peripheral neuropathy.
* Patients with AL who are eligible for ASCT with 200 mg/m2 of melphalan. These are patients <65 years, without cardiac involvement (determined according to the consensus criteria), with eGFR >51mL/min, left ventricular ejection fraction >45%, and bilirubin <2.0 mg/dL. Patients who are eligible for SCT with melphalan 200 mg/m2 but decline the procedure, can be enrolled in the study, but are stratified in a separate stratum before randomization.
* Pregnant or nursing women.
* Clinically overt multiple myeloma with lytic bone lesions
* Patients with uncontrolled infection or active malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
* Patients with medically documented cardiac syncope, uncompensated NYHA Class 3 or 4 congestive heart failure, or myocardial infarction within the previous 6 months are not eligible.
* HIV positive.
* Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Patients with hypersensitivity to bortezomib, boron or mannitol.
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NCT_ID
NCT01277016
|
Study_NameA Trial for Systemic Light-chain (AL) Amyloidosis
| 8,155 |
Study Objectives
The purpose of this study is to evaluate how effective Sunitinib works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib is a protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work by blocking signals on certain cancer cells which allow the malignant cells to multiply and spread due to a change in the genetic make up of the cancer cell.
Conditions: Mucosal Lentiginous Melanoma, Acral Lentiginous Malignant Melanoma
Intervention / Treatment:
DRUG: Sunitinib
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:
* History of primary mucosal or acral/lentiginous melanoma
* Histologically documented stage III unresectable or IV metastatic melanoma
* ECOG Performance Status 0,1 or 2
* Estimated life expectancy of 6 months or greater
* 18 years or older
* Lab values as outlined in protocol
* Tumor blocks or slides must be available of either primary or metastatic tumor site for c-kit mutation testing
* Negative pregnancy test within 48 hours of starting treatment
* At least one measurable site of disease as defined by at least 1cm in greatest dimension
Exclusion Criteria:
* Severe and/or uncontrolled medical disease
* Pregnant or nursing mothers
* Known brain metastasis. History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan
* Less than 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or cervical carcinoma in situ
* Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
* Ongoing cardiac dysrhythmias of grade 2 or greater, atrial fibrillation, QTc interval >450msec for males of >470 msec for females
* Hypertension that cannot be controlled by medication
* Any of the following within 12 months prior to starting treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
* NCI CTCAE version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment
* Concurrent treatment with warfarin
* Prior treatment with SU011248 or any other antiangiogenic agent
* No H2 blockers or proton pump inhibitors
* Known chronic liver disease
* Known HIV infection
* Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 4 weeks prior to study entry
* Major surgery within 4 weeks prior to study entry
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
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NCT_ID
NCT00577382
|
Study_NameSU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
| 1,802 |
Study Objectives
The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide dosing recommendation for subsequent phase II trials in patients with metastatic cancer.
Conditions: Neoplasms
Intervention / Treatment:
DRUG: BIBW 2992, DRUG: BIBF 1120
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion criteria:
* Patients with confirmed histological or cytological diagnosis of advanced solid tumours and for whom no proven therapy exists or who are not amenable to established treatments.
* Age >= 18 years.
* Life expectancy of at least three months.
* Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
* Patients previously treated and with asymptomatic brain metastases are eligible
* Patients must have recovered from recent surgery.
Exclusion criteria:
* Active infectious disease
* Recent surgery within the last 4 weeks prior visit 1.
* Chronic diarrhoea or gastrointestinal tract disease resulting in an inability to take oral medication
* History of haemorrhagic or thrombotic events
* Significant cardiovascular diseases within
* Current peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 except due to trauma
* Untreated or symptomatic brain metastases or leptomeningeal disease.
* Treatment with an Epidermal growth Factor-receptor (EGFR)- or Heregulin Receptor 2 (HER2) inhibiting drug or antiangiogenic drug.
* Therapeutic anticoagulation.
* Female patients of childbearing potential.
* Known pre-existing interstitial lung disease
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NCT_ID
NCT00998296
|
Study_NamePhase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
| 4,736 |
Study Objectives
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity.
All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.
Conditions: Liposarcoma, Leiomyosarcoma, Fibrosarcoma, Malignant Fibrous Histiocytoma
Intervention / Treatment:
DRUG: Sunitinib Malate (SU011248)
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:
* Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.
* Adequate organ function as defined by the following criteria:
* Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
* Total serum bilirubin less than or equal to 1.5 x ULN
* Absolute neutrophil count (ANC) greater than or equal to1500/microL
* Platelets greater than or equal to 100,000/microL
* Hemoglobin greater than or equal to 9.0 g/dL
* Serum calcium less than or equal to 12.0 mg/dL
* Serum creatinine less than or equal to 1.5 x ULN
* Histologically-proven liposarcoma, leiomyosarcoma, fibrosarcoma, or MFH
* Measurable disease radiographically
* Disease that is deemed surgically unresectable and/or metastatic
* Age greater than or equal to 18 years
* Life expectancy greater than 16 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Patients may have had up to 3 prior chemotherapies within 4 weeks of starting the study treatment.
Exclusion Criteria:
* Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment.
* NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment.
* History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease.
* Any of the following within the 6 months prior to study drug administration:
* myocardial infarction,
* severe/unstable angina,
* coronary/peripheral artery bypass graft,
* symptomatic congestive heart failure,
* cerebrovascular accident or transient ischemic attack, or pulmonary embolism
* Ongoing cardiac dysrhythmias of NCI CTCAE greater than or equal to grade 2
* Prolonged QTc interval on baseline electrocardiogram (ECG) > 500 msec.
* Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy)
* Prior tyrosine kinase inhibitor therapy
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
* Concurrent treatment on another clinical trial, except supportive care or non-treatment trials
* Concomitant use of agents known to induce or inhibit CYP3A4
* Concomitant use of agents metabolized by the cytochrome P450 system
* Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg by mouth [PO] daily for thrombo-prophylaxis is allowed)
* Pregnancy or breastfeeding patients
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
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NCT_ID
NCT00400569
|
Study_NamePhase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
| 11,111 |
Study Objectives
This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive breast cancer receiving chemotherapy treatment.
Conditions: Breast Cancer, Neutropenia
Intervention / Treatment:
DRUG: F-627, DRUG: Neulasta
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
* Females >=18 years.
* Diagnosed with Stage I-III breast cancer.
* Subject is scheduled to undergo 4 cycles of neoadjuvant or adjuvant TC chemotherapy (docetaxel, cyclophosphamide, 75, 600 mg/m2, respectively).
* ECOG Performance status of <=2.
* WBC count >=4.0 × 109/L, hemoglobin >=11.5 g/dL and a platelet count >=150 × 109/L.
* Demonstrate adequate renal, hepatic, and cardiac function (liver function tests [alanine aminotransferase {ALT}, aspartate aminotransferase {AST}, alkaline phosphatase, and total bilirubin]) should be less than 2.5x the upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
* All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.
Exclusion Criteria:
* Subject is <18 years.
* Disease progression has occurred while receiving a taxane regimen.
* Subject has undergone radiation therapy within 4 weeks of enrollment.
* Subject has undergone bone marrow or stem-cell transplantation.
* Subject has a history of prior malignancy other than breast cancer that is NOT in remission.
* Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e., lithium) within 6 weeks of the screening period are excluded.
* Subject has had chemotherapy within 180 days of screening.
* Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, electrocardiogram (ECG) test, or any other relevant test.
* History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
* Unwillingness to participate in the study.
* Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
* Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment (if known), which ever is less.
* Any condition, which can cause splenomegaly.
* Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
* ALT, AST, alkaline phosphatase, total bilirubin >=2.5x ULN.
* Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
* Women who are pregnant or breast-feeding.
* Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
* Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
* Subjects with Sickle Cell disease
* Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.
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NCT_ID
NCT03252431
|
Study_NameNeulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
| 2,385 |
Study Objectives
* To identify the common bacterial and fungal species causing fungemia and bacteremia in hematological malignancies.
* To identify sensitivity pattern for causative microbes.
* Compare culture on ordinary media with Vitek2 (automated microbial identification system) and multiplex polymerase chain reaction (PCR )
Conditions: Bloodstream Infection
Intervention / Treatment:
DIAGNOSTIC_TEST: blood culture, OTHER: Anti fungal susceptibility testing or antibiotic susceptibility testing, OTHER: phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France), OTHER: Identification of the isolated organism by multiplex PCR
Location: Egypt
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* hematological malignancy patients on chemotherapy associated with fever
Exclusion Criteria:
* Age below 18 years
|
NCT_ID
NCT03896880
|
Study_NameDetection of Bloodstream Pathogens in Hematological Malignancies
| 5,759 |
Study Objectives
The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
DRUG: TKI258
Location: United States, Spain, United Kingdom, Italy, Taiwan, Canada, France, Finland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Female presenting with metastatic breast cancer.
* Tumor must have been tested by FISH/CISH for FGFR1 amplification.
* HER2 and HR status must have been determined.
* Patients must have HER2 negative breast cancer.
* Patients must have a documented disease progression as define by RECIST at baseline.
* Patients with HR+ disease:
* Must have received at least one prior endocrine therapy in the metastatic setting.
* Must have received no more than three lines of chemotherapy in the metastatic setting.
* Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
Exclusion Criteria:
* Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
* History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
* Clinically significant resting bradycardia (< 50 beats per minute).
* LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)< 45%.
* Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
* Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or without anti-hypertensive medication.
Other protocol-defined inclusion/exclusion criteria may apply
|
NCT_ID
NCT00958971
|
Study_NameSafety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer
| 18,343 |
Study Objectives
The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer.
Conditions: Carcinoma, Hepatocellular
Intervention / Treatment:
DRUG: BAY73-4506
Location: Italy, Germany, Spain, Korea, Republic of
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:
* Male or female patients aged equal or above 18 years.
* BCLC stage Category A, B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib.
* Liver function status Child-Pugh class A.
* Failure to prior treatment with sorafenib (defined as radiological progression under sorafenib therapy)
* Local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed = 4 weeks before first dose of BAY73 <= age <= 4506.
* ECOG PS of 0 or 1.
* Adequate bone marrow, liver and renal function
Exclusion Criteria:
* Prior systemic treatment with molecular targeted agents for HCC, except sorafenib. Prior chemotherapy treatment is allowed.
* Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease).
* Congestive heart failure NYHA>= class 2
* Unstable angina (angina symptoms at rest, new onset angina within the last 3 months) or myocardial infarction (MI) within the past 6 months before start of study medication.
* Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
* Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment.
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NCT_ID
NCT01003015
|
Study_NameSafety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma
| 19,360 |
Study Objectives
Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them. Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had a complete response and 70 patients had a partial response to rituximab. The median duration of response was 11.2 months.
Conditions: Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
Intervention / Treatment:
DRUG: rituximab
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Diagnosis of relapsed, low-grade or follicular B-cell lymphoma
* CD20-positive lymphoma
* Progressive, measurable disease
* Sign informed consent
* 3 weeks beyond standard therapy
* Good performance status
* Adequate hematologic, renal, and hepatic function
Exclusion Criteria:
* Chronic lymphocytic leukemia
* Lesions greater than or equal to 10 cm in diameter
* CNS lymphoma
* AIDS-related lymphoma
* Pleural effusions or ascites secondary to lymphoma
* Active, opportunistic infection
* Serious nonmalignant disease
* Prior investigational therapies, including prior anti-CD20 therapy
* Recent major surgery
|
NCT_ID
NCT00168740
|
Study_NameTreatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102)
| 8,680 |
Study Objectives
This phase II trial studies how well total-body irradiation (TBI) works when given together with fludarabine phosphate and cyclophosphamide followed by donor bone marrow transplant, mycophenolate mofetil, and cyclosporine in treating patients with Fanconi anemia (FA). Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and TBI before or after a donor bone marrow transplant helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
Conditions: Acute Myeloid Leukemia in Remission, de Novo Myelodysplastic Syndrome, Fanconi Anemia, Previously Treated Myelodysplastic Syndrome
Intervention / Treatment:
PROCEDURE: Allogeneic Bone Marrow Transplantation, DRUG: Cyclophosphamide, DRUG: Cyclosporine, DRUG: Fludarabine Phosphate, OTHER: Laboratory Biomarker Analysis, DRUG: Mycophenolate Mofetil, PROCEDURE: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation, RADIATION: Total-Body Irradiation
Location: United States, Brazil
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Any patient with FA and bone marrow (BM) failure involving 2 of the following 3 lineages: granulocyte count < 0.5 x 10^9/L, platelet count < 20 x 10^9/L, or hemoglobin < 8 g/dL
* Any patient with FA who requires red blood cell or platelet transfusions because of marrow failure
* Any patient with FA who has a life-threatening BM failure involving a single hematopoietic lineage
* Any patient with FA and pre-existing cytogenetic abnormality including hematopoietic malignancy (acute myeloid leukemia [AML] or myelodysplastic syndrome [MDS]) in morphological remission (defined as absence of circulating blasts and bone marrow blasts < 5% as assessed by morphology); Note that hematopoietic recovery is not required for remission status
* Patients must have a negative cytotoxic cross match with donor
* DONOR: Related, human leukocyte antigen (HLA)-haploidentical donors must be identical for one HLA haplotype and mismatched for any number of HLA-A, -B, -C, DRB1 or DQB1 loci of the unshared haplotype
* DONOR: Unrelated, HLA-matched donors must be matched at HLA-A, B, C, DRB1 and DQB1 by deoxyribonucleic acid (DNA) typing at the highest resolution routinely available at the time of donor selection; a single allele mismatch at HLA-A, B, or C is allowed OR a single DQB1 mismatch is allowed
* DONOR: Bone marrow will be the only allowed hematopoietic stem cell source
* DONOR: Haploidentical donor selection will be based on standard institutional criteria, otherwise no specific prioritization will be made amongst the suitable available donors
Exclusion Criteria:
* Patients having available HLA-matched related donors
* Significant organ dysfunction that would prevent compliance with conditioning, graft-versus-host disease (GVHD) prophylaxis, or would severely limit the probability of survival, such as liver disease/failure (active hepatitis, moderate to severe portal fibrosis/cirrhosis confirmed by biopsy or uncorrectable hepatic synthetic dysfunction), lung disease, or cardiac disease (ejection fraction < 35%, or if unable to obtain ejection fraction, shortening fraction of < 26%; if shortening is < 26% a cardiology consult is required with principal investigator [PI] having final approval of eligibility)
* Human immunodeficiency virus (HIV) seropositive patients
* Fertile females who are unwilling to use contraceptive techniques during and for the twelve months following treatment, as well as females who are pregnant or actively breast feeding
* Fertile males who are unwilling to use contraceptive techniques during and for the twelve months following treatment
* AML/MDS in morphological relapse, defined as having circulating blasts or bone marrow blasts >= 5% as assessed by morphology
* Active infectious disease concerns
* Karnofsky performance score < 50 or Lansky performance score < 40
* DONOR: Donors found to have Fanconi anemia based on chromosomal breakage analysis
* DONOR: Donors who are not expected to meet the minimum target dose of marrow cells (1 x 10^8 nucleated cells/kg recipient ideal body weight [IBW]) or who are unwilling to be bone marrow donors
* DONOR: HIV-positive donors
* DONOR: Donors who are cross-match positive with recipient
* DONOR: Recipient homozygous at mismatched locus; if the recipient is homozygous at HLA-A, B, or C and the donor is mismatched at that locus, the donor should be avoided; exceptions must be discussed with the PI
|
NCT_ID
NCT00453388
|
Study_NameFludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Fanconi Anemia
| 18,227 |
Study Objectives
This study is to compare the safety and effects of donepezil (Aricept) for patients reporting cognitive or memory issues after receiving chemotherapy for breast cancer. Patients will receive either donepezil or placebo for 24 weeks. The primary objective is to see if memory improves with the use of donepezil during the study.
Conditions: Cognitive Dysfunction, Memory Impairment
Intervention / Treatment:
DRUG: Donepezil 5 mg, DRUG: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Women >=18 years with history of invasive breast cancer
* Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to registration (Ongoing herceptin or other chronic human epidermal growth factor receptor 2 (HER2) directed therapies are allowed).
* Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and plan to continue for the duration of the study (9 months)
* Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks. Patients who were previously on one of these psychotropic medications and have subsequently discontinued the drug must have been off the medication for at least 4 weeks prior to enrollment. Patients who have been on a psychotropic medication for at least 12 weeks but have recently switched to a medicine in the same class (for example, switching from one selective serotonin reuptake inhibitor (SSRI) antidepressant to a different SSRI antidepressant) need to be on a stable dose of the new medication for at least 4 weeks prior to enrollment to be eligible.
* Self-reported cognitive problem plus a measured memory deficit (score <7 on single trial of Eligibility Pre-screen Hopkins Verbal Learning Test - Revised (HVLT-R) Form 3).
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2
* Ability to understand and the willingness to sign a written informed consent document.
* Must be able to speak English.
* Patients currently taking a moderate risk corrected QT interval (QTc) prolongation medication (see Appendix A) are allowed if one of the following criteria are met: 1) The moderate risk QTc prolongation medication is stopped. The patient should be off the moderate risk QTc prolongation medication for at least 5 half-lives before starting study drug. 2) Patients that continue using a moderate risk QTc prolongation medication must have a normal QTc interval (<= 460 milliseconds) on a screening ECG following informed consent and prior to study enrollment. These patients will also be monitored at designated study follow-up visits per Section 7.5 (monitored 3 <= age <= 7 days after initiating study drug, at week 3, and 3 <= age <= 7 days after the study drug dose increase with ECG's to assess the QTc interval; the QTc level must be <= 500 milliseconds at these time points in order to continue on the study drug). 3) Moderate risk QTc prolongation medications that are only taken occasionally may be stopped at the discretion of the treating site physician. Patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible.
* Patients currently taking a moderate risk bradycardia-causing agent (see Appendix B) are allowed if one of the following criteria are met: 1) The moderate risk bradycardia-causing agent is stopped. The patient should be off the moderate risk bradycardia-causing agent for at least 5 half-lives before starting study drug. 2) Patients that continue using a moderate risk bradycardia-causing agent must have a resting heart rate >= 55 beats per minute at screening following informed consent. These patients' resting heart rate will be monitored 3 <= age <= 7 days after initiating study drug, at week 3, and 3 <= age <= 7 days after the study drug dose increase per Section 7.5. 3) Moderate risk bradycardia-causing agents that are only taken occasionally may be stopped at the discretion of the treating site physician. Patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible.
Exclusion Criteria:
* Evidence or suspected recurrent or metastatic disease.
* Prior brain irradiation is not allowed.
* Planned therapy (surgery, radiation, chemotherapy, or immunotherapy) while on the study for brain and/or extracranial primary/metastatic disease.
* Hypersensitivity to donepezil or piperidine derivatives
* Current use of ceritinib
* Current use of Succinylcholine/Acetylcholinesterase Inhibitors(as listed in Appendix C). For patients who have used these medications, they must not have used them within 4 weeks prior to enrollment.
* Current use of high-risk QTc prolonging medication(s). See Appendix D
* Current use of quinidine or systemic ketoconazole (topical ketoconazole is acceptable to use while on study).
* History of dementia, Alzheimer's disease, multi-infarct dementia or clinically significant Cerebrovascular Accident (history of transient ischemic attack (TIA) is allowed).
* Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drug(s). For patients who have used these medications, they must not have used them within 4 weeks prior to pre-screening. Patients who plan to start taking a cognition enhancing drug while on this study are also excluded.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to donepezil. Hypersensitivity to donepezil.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia.
* Major medical conditions that affect cognition, traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia.
* Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse.
* Untreated current severe depression. Currently treated depression is permitted if treatment is stable.
* Patients with a resting heart rate less than 55 beats per minute, seizure disorder or peptic ulcer disease (PUD).
* History of congenital long QT syndrome or torsades de pointes.
* Screening QTc of > 460 milliseconds will make the patient ineligible.
* Pregnant women are excluded from this study. Following informed consent, women of child-bearing potential will be screened with a serum or urine pregnancy test within 10 days of enrollment. The effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because donepezil is known to be teratogenic, women of child-bearing potential 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 study physician immediately.
* It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study.
* On another intervention study involving medication at the time of enrollment or during participation in this study. (Exception: Patients will remain eligible for this study if they are also enrolled on the Alliance for Clinical Trials in Oncology study (NCT02927249): Aspirin in Preventing Recurrence of Cancer in Patients with HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy. Studies that involve only blood draws or questionnaires are also permitted.)
* Use of investigational drugs likely to affect cognition within 30 days prior to pre-screening visit.
|
NCT_ID
NCT02822573
|
Study_NamePhase 3 Randomized Placebo Controlled Clinical Trial of Donepezil
| 1,734 |
Study Objectives
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.
Conditions: Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
Intervention / Treatment:
DRUG: Paclitaxel, DRUG: Trastuzumab, DRUG: Pertuzumab, DRUG: Palbociclib, DRUG: Letrozole, DRUG: Trastuzumab, DRUG: Pertuzumab
Location: Belgium, Switzerland, France, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed invasive breast cancer, with the following characteristics:
* Early breast cancer with tumor size >1 cm (as measured by at least one of the required examination methods of clinical examination, mammography and ultrasonography);
* No clinical evidence of regional lymph node metastasis (via physical and/or radiological exam) (cN0) OR
* Clinical evidence of cN1 status, defined by nodal involvement limited to clinically or radiologically detectable metastasis to movable ipsilateral level I, II axillary lymph node(s)
* No evidence of metastasis (M0).
* Postmenopausal, defined by women with:
* Prior bilateral surgical oophorectomy; OR
* Amenorrhea and age >=60 years; OR
* Age <60 years and amenorrhea for 12 or more consecutive months in the absence of alternative pathological or physiological cause (including chemotherapy, tamoxifen, toremifene, ovarian suppression, or hormonally-based contraception) plus FSH and serum estradiol levels within the laboratory's reference ranges for postmenopausal women
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Primary tumor must have positive estrogen receptor (ER) >=10%
* Primary tumor must be HER2-positive (by IHC and/or ISH)
* Baseline LVEF >=55% measured by Echocardiography (preferred) or MUGA scan
* Normal hematologic status:
* Absolute neutrophil count >=1500/mm3 (1.5 × 109/L);
* Platelets >=100 × 109/L;
* Hemoglobin >=9 g/dL (>=90 g/L).
* Normal renal function: serum creatinine <=1.5 ULN
* Normal liver function:
* Serum total bilirubin <=1.5 × upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 × ULN) is allowed;
* AST or ALT <=2.5 × ULN;
* Alkaline phosphatase <=2.5 × ULN.
* Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
* The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
* The patient agrees in writing to make tumor (mandatory diagnostic core biopsy and surgical specimen) available for submission for central pathology review and to conduct translational studies as part of this protocol.
Exclusion Criteria:
* Tumor of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) (T4 according to AJCC 8th edition cancer staging TNM)
* Inflammatory breast cancer
* Bilateral invasive breast cancer
* Received any prior treatment for primary invasive breast cancer
* Any active tumor of non-breast-cancer histology
* Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina pectoris, ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA functional classification >=II), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
* Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety
* Contraindications or known hypersensitivity to any of the trial medications or excipients
* Treatment with any investigational agents within 30 days prior to expected start of trial treatment
* Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post major bowel resection
* Evidence via physical and/or radiological exam of cN2 or cN3 nodal involvement defined by: metastasis to ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted, OR involvement of ipsilateral infraclavicular, internal mammary and/or supraclavicular lymph node(s)
* History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis. A history of prior radiation pneumonitis is not considered an exclusion criterion.
|
NCT_ID
NCT03644186
|
Study_NameTo Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)
| 2,911 |
Study Objectives
This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.
Conditions: Tuberous Sclerosis Complex (TSC), Lymphangioleiomyomatosis (LAM)
Intervention / Treatment:
DRUG: Everolimus (RAD001), DRUG: Everolimus Placebo
Location: Poland, Germany, United States, Spain, United Kingdom, Italy, Japan, Netherlands, Canada, Russian Federation, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Male or Female >= 18 years
* Clinically definite diagnosis of Tuberous Sclerosis Complex according to the modified Gomez criteria or sporadic LAM (biopsy-proven or compatible chest CT scan)
* Clinically definite diagnosis of renal angiomyolipoma
* At least one Angiomyolipoma of >= 3 cm in its longest diameter using CT or MRI
* Females of child bearing potential must use birth control and have documentation of negative pregnancy test
* Written informed consent according to local guidelines
Exclusion Criteria:
* Recent heart attack, cardiac related chest pain or stroke
* Severely impaired lung function
* Bleeding related to angiomyolipoma or embolization during 6 months prior to randomization
* Clinically significant chylous ascites
* Clinically significant hematological or hepatic abnormality
* Severe liver dysfunction
* Severe kidney dysfunction
* Pregnancy or breast feeding
* Current infection
* History of organ transplant
* Surgery within two months prior to study enrollment
* Prior therapy with a medication in the same class as Everolimus
* Recent use of an investigational drug
* Bleeding diathesis or on oral anti-vitamin K medication
* Uncontrolled high cholesterol
* Uncontrolled diabetes
* HIV
* Inability to attend scheduled clinic visits
* Patients with metal implants thus prohibiting MRI evaluations
* Angiomyolipoma which requires surgery at the time of randomization
* History of malignancy
* Severe or uncontrolled medical conditions which would cause an unacceptable safety risk or compromise compliance with the protocol
|
NCT_ID
NCT00790400
|
Study_NameEfficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
| 11,411 |
Study Objectives
This study is a single-armed, open-label, single-center phase II trial of signal transduction inhibitor number 571 (STI-571) systemic therapy in selective patients with metastatic melanoma, and aims to study the efficacy and safety. The primary endpoint is progression-free survival (PFS) and the second endpoints are overall response rate (ORR), overall survival (OS), 1-year OS and safety.
Conditions: Metastatic Melanoma
Intervention / Treatment:
DRUG: Imatinib (Gleevec)
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed melanoma with metastases and has no received any systemic treatment within 1 month
* Evidence of mutations and/or copy number increases of KIT with laboratory examination documented from either primary or metastatic tumor site
* ECOG performance status 0, 1, or 2
* Estimated life expectancy of 6 months or greater
* Age >= 18 years, male of female
* At least one measurable site of disease
* Adequate organ function
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion Criteria:
* Melanoma from primary sites other than acral or mucosal melanoma
* Received systemic anti-cancer therapy within 1 month before enrollment for metastatic disease
* Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
* Severe and/or uncontrolled concomitant medical diseases
* pregnant or childbreeding women
* Known hypersensitivity to imatinib
* Current treatment on another clinical trial
|
NCT_ID
NCT00881049
|
Study_NameTrial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma
| 8,338 |
Study Objectives
This randomized phase II trial studies how well nab-paclitaxel and bevacizumab or ipilimumab works as first-line therapy in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as nab-paclitaxel, 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. Bevacizumab may stop the growth of tumor cells by binding to a protein called vascular endothelial growth factor (VEGF) and by preventing the growth of new blood vessels that tumors need to grow. Ipilimumab blocks a substance called cytotoxic T-lymphocyte-associated antigen-4 (CTLA4) on the surface of T cells and may help the immune system kill cancer cells. It is not yet known whether nab-paclitaxel and bevacizumab is more effective than ipilimumab in treating melanoma.
Conditions: Metastatic Melanoma, Mucosal Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IV Uveal Melanoma AJCC v7, Unresectable Melanoma
Intervention / Treatment:
BIOLOGICAL: Bevacizumab, BIOLOGICAL: Ipilimumab, OTHER: Laboratory Biomarker Analysis, DRUG: Nab-paclitaxel, OTHER: Pharmacological Study
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
|
Inclusion Criteria:
* Histologic or cytologic proof of surgically unresectable stage IV malignant melanoma - including that of uveal and mucosal origin
* Note: biopsy can be of locoregional disease in setting of clinically evident stage IV disease; a biopsy of the primary tumor alone does not fulfill this requirement
* No more than 2 prior courses of systemic therapy for metastatic melanoma
* For patients with metastatic melanoma not of uveal origin, v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation determination using a Clinical Laboratory Improvement Amendments (CLIA)-approved testing method on metastatic tumor tissue
* NOTE: patients with metastatic melanoma of uveal origin do not need to have formal BRAF testing due to low probability of a BRAF V600 mutation in their metastatic tumor
* Measurable disease; note: disease that is measurable by physical examination only is not eligible
* Life expectancy of >= 4 months
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Absolute neutrophil count >=1500/mL (obtained =< 14 days prior to registration/randomization)
* Platelet count >= 100,000 x 10^9/L (obtained =< 14 days prior to registration/randomization)
* Hemoglobin >= 9 g/dL (obtained =< 14 days prior to registration/randomization) (patients may be transfused to meet this requirement)
* Creatinine =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration/randomization); institutional norms are acceptable
* Total bilirubin =< 1.5 mg/dL (obtained =< 14 days prior to registration/randomization) (exception: patients with documented Gilbert?s syndrome are allowed to participate despite elevated bilirubin)
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 x ULN and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN (obtained =< 14 days prior to registration/randomization)
* Alkaline phosphatase =< 2.5 x ULN (obtained =< 14 days prior to registration/randomization); if bone metastasis is present in the absence of liver metastasis then =< 5 x ULN
* Urine dipstick for proteinuria < 2+ (obtained =< 14 days prior to registration/randomization) (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1 g of protein in 24 hours to be eligible)
* Negative serum pregnancy test done =< 7 days prior to registration/randomization, for women of childbearing potential only
* Note:
* Females: adequate contraception must be used by both patient and partner while receiving study drug and for 12 weeks after the last dose of study drug
* Males: adequate contraception must be used by both patient and partner while receiving study drug; men who have a partner of childbearing age should also avoid fathering a child for 6 months after the last dose of study drug
* Ability to understand and the willingness to sign a written informed consent document
* Mayo Rochester patients only: willingness to provide mandatory blood samples for research purposes
Exclusion Criteria:
* Brain metastases per magnetic resonance imaging (MRI) or computed tomography (CT)
* Note: patients who have had therapy for brain metastasis (i.e., surgical resection, whole brain radiation, or stereotactic radiosurgery [SRS] even if stable) are not eligible
* Other investigational agents =< 4 weeks prior to registration/ randomization
* Anti-cancer therapy (including immunotherapy) =< 4 weeks prior to registration/randomization; exception: adjuvant Leukine =< 14 days prior to registration/randomization
* Prior treatment in the adjuvant or metastatic setting with any of the following:
* Agents disrupting VEGF activity or targeting vascular endothelial growth factor receptor (VEGFR);
* Ipilimumab;
* Or taxane based chemotherapy regimens (including paclitaxel, docetaxel, cabazitaxel or nab-paclitaxel)
* Major surgical procedure, open biopsy, or significant traumatic injury =< 4 weeks prior to registration/randomization; (port-a-cath placement does not count as a major surgical procedure and patients can be enrolled at any time after placement)
* Fine needle aspirations or core biopsies =< 7 days prior to registration/ randomization
* Planned/or anticipated major surgical procedure during the course of the study
* Other medical conditions including but not limited to:
* History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C
* Active infection requiring parenteral antibiotics
* Poorly controlled high blood pressure (>= 150 mmHg systolic and/or 100 mmHg diastolic) despite treatment
* New York Heart Association class II-IV congestive heart failure
* Serious cardiac arrhythmia requiring medication
* Myocardial infarction or unstable angina =< 6 months prior to registration/randomization
* Clinically significant peripheral vascular disease
* Deep venous thrombosis or pulmonary embolus =< 1 year of registration/randomization
* Ongoing need for full-dose oral or parenteral anticoagulation
* Ongoing anti-platelet treatment other than low-dose aspirin (i.e., aspirin 81 mg by mouth daily)
* Active bleeding or pathological conditions that carry high risk of bleeding (e.g., known esophageal varices, etc.)
* Serious, non-healing wound (including wounds healing by secondary intention), ulcer or bone fracture
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess =< 6 months prior to registration/randomization
* History of central nervous system (CNS) disease (e.g., vascular abnormalities, etc.), clinically significant stroke or transient ischemic attack (TIA) =< 6 months prior to registration/randomization, seizures not controlled with standard medical therapy
* Radiographically documented tumor invading major blood vessels
* History of hypertensive crisis or hypertensive encephalopathy
* Any of the following:
* Pregnant women
* Nursing women
* Men and women of reproductive potential who are not using effective birth control methods Note: women of childbearing potential must have a negative serum pregnancy test =< 7 days prior to registration/randomization; adequate contraception must be used while receiving study drug and for 12 weeks after the last dose of study drug, by both women and men and by both patient and partner; men who have a partner of childbearing potential should also avoid fathering a child for 6 months after the last dose of study drug
* Existence of peripheral sensory neuropathy >= grade 2 (from any cause)
* History of other malignancy =< 5 years with the exception of basal cell or squamous cell carcinoma of the skin, treated with local resection only, or carcinoma in situ (e.g. of the cervix, breast, prostate, etc.)
* Radiation therapy (other than palliative) =< 2 weeks prior to randomization; note: patients who have had > 25% of their functional bone marrow irradiated are not eligible for this trial
* Active or recent history of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) =< 30 days prior to registration/randomization
* Known hypersensitivity to any of the components of ipilimumab, bevacizumab, or nab-paclitaxel
* History of inflammatory bowel disease (e.g., Crohn?s, ulcerative colitis) - note patients with irritable bowel syndrome are eligible
* Diagnosis of autoimmune disease (i.e., rheumatoid arthritis, scleroderma, systemic lupus erythematosus [SLE], autoimmune vasculitis, Guillain-Barre syndrome, etc.), regardless if patient is currently receiving treatment at time of registration/randomization
* Systemic corticosteroids use =< 2 weeks, regardless of indication; note: patients who are on inhaled corticosteroids are eligible
|
NCT_ID
NCT02158520
|
Study_NameNab-Paclitaxel and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery
| 1,986 |
Study Objectives
The aim of this study is to compare the efficacy (in terms of event-free survival and overall survival) of an adjuvant therapy with IFN-alpha plus low-dose of IL2 vs a wait-and-see program in patient with radically operated renal cell carcinoma.
Conditions: Carcinoma, Renal Cell
Intervention / Treatment:
DRUG: Interferon Alfa-2a, DRUG: Interleukin-2
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Diagnosis histologically confirmed of renal cells carcinoma (every histotype);
* Age < 75 years
* Radical surgical removal of the tumor: total or partial nephrectomy within previous 3 months
* Patient classified as T1 (with diameter > 2,5 cm), T2, T3 a-b-c; In presence of involvement of loco-regional lymph-nodes (staging N1, N2, N3, TNM class.), metastases should have been completely removed during nephrectomy
* Absence of distant metastases;
* Written informed consent
Exclusion Criteria:
* Tumor diameter equal or less than 2,5 cm;
* Previous chemotherapy or ormonotherapy o immunotherapy;
* Renal insufficiency >3 mg/dl);
* No symptomatic arrhythmias or autoimmune disease
|
NCT_ID
NCT00502034
|
Study_NameLow-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma.
| 6,546 |
Study Objectives
This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Dociparstat sodium, DRUG: Idarubicin, DRUG: Cytarabine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
Subjects had to meet all the following criteria to be eligible for enrollment in this study:
* Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML).
* Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion Criteria:
Subjects who met any of the following criteria were not eligible for enrollment in this study:
* Had acute promyelocytic leukemia
* Had prior chemotherapy for AML.
* Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome.
* Had central nervous system (CNS) leukemia.
|
NCT_ID
NCT02873338
|
Study_NameDociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
| 14,243 |
Study Objectives
The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.
Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Leukemia, Myelomonocytic, Chronic
Intervention / Treatment:
DRUG: azacitidine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* >= 18 years
* Diagnosis of MDS or CMML
* Diagnosis of AML, Multiple myeloma, Hodgkin's or Non-Hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective
* ECOG Performance Status 0 <= age <= 2
* Use of acceptable birth control
* Standard safety inclusion for serum creatinine, AST, ALT, bilirubin
* Serum bicarbonate greater than or equal to 20 mEq/L
* Platelet count greater than or equal to 25,000/uL
* Hemoglobin greater than or equal to 500/uL
* Signed informed consent
Exclusion Criteria:
* Diagnosis of acute promyelocytic leukemia
* Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
* Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment
* Hypersensitivity to azacitidine or mannitol
* Active, uncontrolled infection
* Presence of GI disease, malignant tumors or other conditions known to interfere with ADME
* Known or active HIV, viral hepatitis B or C
* Breastfeeding or pregnant females
* Current or uncontrolled cardiac disease
|
NCT_ID
NCT00761722
|
Study_NameSafety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma
| 2,811 |
Study Objectives
This study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.
Conditions: Radiation Dermatitis
Intervention / Treatment:
OTHER: 3M™ Cavilon™ Advanced Skin Protectant
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Age >= 18years.
* Patient has initial or recurrent disease
* Undergoing external beam radiotherapy at the Mayo Clinic Rochester campus Note: Patients who are undergoing concurrent chemotherapy are eligible
* Ability to complete questionnaire(s) by themselves or with assistance
* Provide informed written consent
* Willing to consent for photography of radiation field
* Available to return to Mayo Clinic in within 1 week post treatment for assessment (+/- 7 days).
* At risk for developing >= grade 2 dermatitis radiation as determined by treating Radiation Oncology clinician
* Biologic effective dose of >42 Gy10 as calculated using the web site EQD2.com.
Exclusion Criteria:
* Unable to provide informed consent
* Patients with active rash, pre-existing dermatitis, lupus or scleroderma within the treatment area that may make skin assessment for the study difficult
* Known history of developing an allergic reaction after using a product containing cyanoacrylate or acrylates
* Subject has a medical condition that in the opinion of the investigator should exclude him/her from participating in the study
* Subject has been enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit
* The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)
|
NCT_ID
NCT03546803
|
Study_Name3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis
| 17,043 |
Study Objectives
The objectives of this study are to evaluate the effectiveness of Pycnogenol (French maritime pine bark extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and sensitivity of bioelectric impedence as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.
Conditions: Lymphedema
Intervention / Treatment:
DRUG: Pycnogenol, DRUG: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: DOUBLE
|
Inclusion Criteria:
* > 6 months from last surgical and/or radiation treatment to the affected axilla
* Unilateral lymphedema of the upper extremity
Exclusion Criteria:
* May not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this study
|
NCT_ID
NCT00214032
|
Study_NamePycnogenol for the Treatment of Lymphedema
| 15,708 |
Study Objectives
Pioglitazone and insulin glargine are equally effective in achieving glycemic control in secondary drug failure of type 2 diabetes but the mechanisms of actions are different.
Conditions: Type 2 Diabetes, Secondary Drug Failure
Intervention / Treatment:
DRUG: pioglitazone, DRUG: insulin glargine
Location: Sweden
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* type 2 diabetes
* inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin
Exclusion Criteria:
* heart failure (NYHA II-IV)
|
NCT_ID
NCT00609856
|
Study_NamePioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
| 18,895 |
Study Objectives
This is a monocenter, single-arm, open label phase II trial evaluating the effect of SOM230 LAR in adult patients with inoperable primary thymoma and thymoma metastasis (Masaoka II-IVa). SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks. The purpose of this trial is a proof of concept.
Conditions: Primary Inoperable Thymoma, Local Recurrent Thymoma
Intervention / Treatment:
DRUG: SOM230 LAR
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Male or female patients aged >=18 years
* Diagnosis of thymoma as assessed by biopsy and/or szintigraphy
* Inoperability of thymoma or loco-regional metastases. Inoperability is defined as at least adherence of the tumor to the neighbored organs, suspicious to infiltrate neighbored organs or local metastasis so that R0 resection can not be expected and /or local recurrence of thymic tumor
* Tumor stage: Thymomas of all WHO based histological subtypes (WHO A, AB, B1, B2, B3) (Rosai, 1999; Travis 2004) at Masaoka stage II to IVa based on histological examination of resection specimens or core biopsies.
* Patients with and without thymoma associated paraneoplastic syndrome.
* Performance status 0,1, or 2 (ECOG)
* Patients for whom written informed consent to participate in the study has been obtained
Exclusion Criteria:
* Patients having received radiolabeled somatostatin analogue therapy within the 6 months or any cytotoxic chemotherapy or interferon therapy within the 2 months prior to recording baseline symptoms
* Patients who have undergone major surgery/surgical therapy for any cause within 1 month or surgical therapy of loco-regional metastases within the last 3 months before recording baseline symptoms
* Patients who have received radiotherapy for any reason within the last 4 weeks and must have recovered from any side effects of radiotherapy before recording baseline symptoms
* Patients who are not biochemically euthyroid
* Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as indicated by HbA1C > 8%
* Patients with symptomatic cholelithiasis
* Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
* Patients with QT related risk factor: QTcF at screening > 450 msec
* Patients with QT related risk factor: History of syncope or family history of idiopathic sudden death
* Patients with QT related risk factor:Sudden or clinically significant cardiac arrhythmias
* Patients with QT related risk factor: Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant / symptomatic bradycardia, or high-grade AV block
* Patients with QT related risk factor: Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
* Patients with QT related risk factor: Concomitant medication(s) known to increase the QT interval
* Patients with potassium <3.0 mmol/L at study entry, magnesium <0.4 mmol/L at study entry, calcium <1.75 mmol/L at study entry, family history of long QT syndrome, and concomitant medications known to prolong the QT interval. If the electrolyte abnormalities are corrected prior to study commencement, the patient may become eligible for the trial.
* Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis with serum bilirubin > 1.5 X ULN, serum albumin < 0.67 X LLN, and/or ALT or AST more than 2 X ULN for patients without liver Confidential - 20 - Amended Clinical Study Protocol v01 / Track Changes Study No. CSOM230CIC01T metastases or ALT or AST more than 5X ULN for patients with documented liver metastases
* Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
* Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
* Patients with abnormal coagulation (PT or APTT elevated by 30% above normal limits)
* Patients with WBC <2.5 X 109/L; Hgb <10 g/dL; PLT <100 X 109/L (patients with paraneoplastic pan-, leuco-, erythro- or thrombopenia can be included if this seems to be the only reason for pan-, leuco-, erythro- or thrombopenia)
* Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations
* Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator
* Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use a secure method of contraception if sexually active and the partner should use a condom. If oral contraception is used, the patient must have been practicing this method for at least two months prior to enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three months afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs). Female partners of these male patients should use a secondary barrier contraception.
* Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
* Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
* Patient has received any other investigational agents within 28 days of first day of study drug dosing
* Abnormal clinical laboratory values considered by the investigator to be clinically significant and which could affect the interpretation of the study results
|
NCT_ID
NCT02021942
|
Study_NameEfficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size
| 11,589 |
Study Objectives
To determine the maximum tolerated dose of lenalidomide in patients with adult T-cell leukemia-lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) who have previously received therapy for ATL and PTCL
Conditions: Adult T-cell Leukemia-Lymphoma, Peripheral T-cell Lymphoma
Intervention / Treatment:
DRUG: Lenalidomide
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Subject must understand and voluntarily sign the written informed consent;
* Aged >= 20 years;
* Subject have a documented diagnosis of either:
* Acute-, lymphoma-, or unfavorable chronic-type ATL or
* Peripheral T-cell Lymphomaperipheral (PTCL)
* Subject have received >=1 prior anti-cancer therapy, have achieved stable disease (SD) or better on their immediately prior therapy and have relapsed or progressed at the time of obtaining signed informed consent;
* Subject have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2 at enrollment;
Exclusion Criteria:
* Natural Killer cell lymphoma (NK-cell lymphoma);
* T-cell leukemia;
* Cutaneous T-cell lymphoma (CTCL) including;
* Mycosis fungoides
* Sezary syndrome
* CD30-positive lympho-proliferative disorders
* Cutaneous gamma/delta T-cell lymphoma
* Subject have a history of central nervous system (CNS) involvement or present with CNS symptoms, and are diagnosed with CNS lymphoma by cerebrospinal fluid (CSF) cytology examination, head CT scan or brain MRI during the screening;
* Are pregnant or lactating;
* Subject have uncontrolled inter-current illness including:
* Uncontrolled diabetes mellitus
* Chronic congestive heart failure (NYHA Class III or IV)
* Unstable angina pectoris, angioplasty, stenting, or myocardial infarction (within 6 months before starting the study drug)
* Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia
* Other uncontrolled diseases
* Exhibit grade 4 neurological disorders;
* Subject have a history or complication of deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment;
* Develop active tuberculous disease, herpes simplex, systemic mycosis, or other active infections requiring systemic administration of antibiotics, antiviral agents, or antifungal drugs;
* Are tested positive for HBs antigen, anti-HCV antibody, or anti-HIV antibody;
* Subjects have a history or complication for which the investigator or subinvestigator deems them inappropriate for this study, or have serious diseases or mental illness that is likely to be aggravated by participation in this study;
* Subjects have a history of allogeneic stem cell transplantation;
* Subjects have received autologous stem cell transplantation within 12 weeks (84 days) of the start of study treatment;
* Have previously used lenalidomide;
* Have a history of desquamating (bullous) rash while taking thalidomide;
* Have received any investigational drugs (unapproved drugs in Japan) within 4 weeks (28 days) of the start of study medication;
* Have received chemotherapeutic agents or immunomodulators for the treatment of ATL or PTCL within 4 weeks (28 days) of the start of study treatment;
* Have received radiotherapy within 4 weeks (28 days) of the start of study treatment;
* Have a history or complication of another malignant tumor than ATL or PTCL (excluding malignant tumors below), unless the patients have been free of the disease for 5 years or longer;
* Cutaneous basal cell carcinoma or squamous cell carcinoma
* Cervical carcinoma in situ
* An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b)
* Have had any of the following abnormal measurements at screening performed within 1 week (7 days) prior to the enrollment;
* Neutrophil count: < 1,200/µL (1.2 x 109/L)
* Platelet count: < 75,000/µL (75 x 109/L)
* Serum aspartate aminotransferase/ Serum glutamic oxaloacetic transaminase (AST/SGOT) or Alanine transaminase/Serum Glutamic Pyruvate Transaminase (ALT/SGPT): > 3 times the Upper Limit of Normal (ULN)
* Bilirubin level: > 1.5 times of the ULN
* Creatinine clearance: < 60 mL/min
|
NCT_ID
NCT01169298
|
Study_NameA Phase I, Multicenter, Open-label, Dose-escalation Study to Assess the Safety of Lenalidomide in Patients With Advanced Adult T-cell Leukemia-lymphoma and Peripheral T-cell Lymphomaperipheral T-cell Lymphoma
| 20,666 |
Study Objectives
After endoscopic resection of early gastric cancer (EGC), there remained concerned about the development of the metachronous gastric neoplasm (MGN). The aim of this study was to evaluate the role of H. pylori eradication for reducing MGN after ESD and the efficacy of serum pepsinogen (PG) for predicting development of MGN after endoscopic submucosal dissection (ESD) for EGC and to evaluate other risk factors for the incidence of MGN. The investigators enrolled the participants who were tested serum PG I and II at the time of ESD for EGC, from January 2007 to May 2013 in single tertiary center, retrospectively. The baseline characteristics of the participants, H. pylori status, and serum pepsinogen were analyzed for the development of the MGN.
Conditions: Gastric Cancer
Intervention / Treatment:
DRUG: H pylori eradication
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* The patients who tested serum PG concentration test and H. pylori status at the time of ESD and revealed pathologically complete en bloc resection after ESD for EGC.
Exclusion Criteria:
* previous history of ER; proven pathologically incomplete resection or lympho-vascular invasion on the resected ESD specimen; additional treatment after ESD; and follow-up loss less than 2 years.
|
NCT_ID
NCT02682446
|
Study_NameThe Efficacy of Serum Pepsinogen for Prediction of Metachronous Gastric Neoplasm
| 9,339 |
Study Objectives
The purpose of a phase Ib study is to find out the best or maximum tolerated dose of a medication or combination of medications. Therefore, the purpose of this study is to decide the best dose of the study drug, Debio 1347, that can be given in combination with the standard hormonal drug, fulvestrant. Debio 1347 and fulvestrant could shrink the cancer but it could also cause side effects. This study tells us about the side effects of these drugs when given in this new combination, and how often they occur.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Fulvestrant, DRUG: Debio 1347
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:
* Males and Females Age > 18 years
* Written informed consent and authorization obtained from the subject/HIPAAappointed legal representative prior to performing any protocol-related procedures including screening evaluations
* Patients with metastatic histologically or cytologically confirmed invasive breast cancer
* Female patients of postmenopausal status. with metastatic histologically or cytologically confirmed invasive breast cancer.
* Postmenopausal status will be defined as following:
* Age >= 60 years
* Age < 60 years and 12 months of amenorrhea plus follicle stimulating hormone and plasma estradiol levels within postmenopausal range by local laboratory assessment in the absence of oral contraceptive pills, hormone replacement therapy, or gonadotropin-releasing hormone (GnRH) agonist or antagonist
* Prior bilateral oophorectomy
* Pre or perimenopausal women allowed with the addition of goserelin
* ECOG performance status 0 -1
* Tumor must be estrogen receptor and/or progesterone receptor positive ( i.e. Hormone receptor positive (HR+) and HER-2 negative as defined by the ASCO-CAP guidelines: HR+ is defined as expression of ER and/PR in >= 1% of cells, or HR+ by local laboratory or regional definition. HER2- is defined as a HER2 IHC score of 0 or 1+ , or an IHC score of 2+ accompanied by a negative fluorescence, chromogenic, or silver in situ hybridization test indicating the absence of HER2 gene amplification, or a HER2/CEP17 ratio of < 2.0, or local clinical guidelines.
* Tumors must have FGFR amplifications as determined by a CLIA certified laboratory. Patients with FGFR amplifications co-occurring with 11q amplification (CCND1, FGF3,4, 19 amplifications) are also eligible.
* Measurable or evaluable disease per RECIST1.1 or pure lytic or mixed lytic-blastic bone lesions
* No more than 1 prior chemotherapy regimen in the metastatic setting for the phase 2 portion. Patients in the phase 1 portion could have received any number of prior lines of therapy.
* Willing to undergo a new core or excisional biopsy from a metastatic, not previously irradiated tumor lesion during screening
* Life expectancy of greater than 3 months
* Archival Tumor (up to 10 unstained slides) will be obtained, whenever available for additional biomarker analyses
* Hematologic parameters:
* White blood cell (WBC) count of > 3000/ul
* Absolute neutrophil count (ANC) > 1000/ul
* Platelets > 100,000/ul, hemoglobin > 9.0 g/dl
* Non-hematologic parameters:
* Corrected calcium value <= 1.1 x ULN
* Total bilirubin <=1.5 x ULN (upper limit of normal) except subject with documented Gilbert"s syndrome (<=5 x ULN) or liver metastasis, who must have a baseline total bilirubin <=3.0 mg/dL
* AST and ALT <= 3 x ULN, unless associated with hepatobiliary metastases, in that case <=5 x ULN
* ALP <= 2.5 x ULN or <= 5.0 x ULN for patients with bone metastases
* Gamma-glutamyltransferase <= 2.5 x ULN
* Albumin >= 2.5 g/dL
* Phosphat <= 1.1 x ULN
* Prothrombin time (PT) and/or prothrombin time international normalized ratio (PT-INR) and/or activated partial thromboplastin time (APTT) <= 1.3 x ULN
* Serum creatinine <= 1.5 × ULN or creatinine clearance >= 50 mL/min on the basis of the
Cockcroft-Gault glomerular filtration rate estimation:
(140 - age) × (weight in kg) × (0.85 if female, 1.0 if male) 72 × (serum creatinine in mg/dL)
* Patients with "treated and stable" brain lesions for a duration of > 4 weeks may be enrolled.
* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication and agree to use effective contraception. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Exclusion Criteria:
* Prior Fulvestrant for metastatic breast cancer will be allowed for phase 1 portion but not for the phase 2 portion
* History of hypersensitivity to any of the excipients in the Debio 1347 formulation (lactose hydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate, and magnesium stearate).
* Other malignancies requiring active treatment in the last 6 months.
* Brain tumors and/or brain metastases unless they are asymptomatic, stable on recent imaging (not dated more than 30 days from the inclusion date), and have not required active treatment in the last 6 months.
* History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis.
* History of myocardial infarction or stroke within 6 months, congestive heart failure greater than NYHA class II, unstable angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring treatment or family history of sudden death from cardiacrelated causes.
* Baseline Frederica"s corrected QT (QTcF) interval greater than 470 msec (female) or greater than 450 msec (male), history of congenital long QT syndrome, the presence in the screening ECG of a conduction abnormality that in the opinion of the Investigator would preclude safe participation in this study.
* Concomitant use of a drug with a known risk of QTc prolongation
* Current anticoagulation therapy with therapeutic doses of warfarin (low-dose warfarin <= 1mg/day or low molecular-weight heparin are permitted).
* History and or current evidence of ectopic mineralisation/calcification including but not limited to the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification.
* Concomitant use of high dose systemic steroids and other drugs such as calcitonin preparations, active Vitamin D3 preparations, estrogen preparations, selective estrogen receptor modulators, Vitamin K2 preparations, parathyroid hormones, phosphorus absorbers. Note, inhaled, topical steroids and low tapering doses of steroid especially in patients treated recently for brain metastases will be included.
* Corneal disease, such as bullous or band keratopathy, corneal desquamation, keratitis, corneal ulcer, or keratoconjunctivitis.
* Known infection requiring the systemic use of, for example, an antibiotic or antiviral agent.
* Known HIV, HBV or HCV infection.
* Known untreated or uncontrolled acute infection, including urinary tract infection, within 7 days of study entry.
* History of organ, bone marrow, or stem cell transplantation.
* Pregnant or lactating woman (any woman of childbearing potential who has menstruated within the year prior to enrolment will undergo pregnancy testing within 72 hours prior to receiving the first dose of study medication).
* Women of childbearing potential or men who are unwilling to use an appropriate method of contraception during the study period and for 6 months after completing treatment with Debio 1347. Oral or injectable contraceptive agents cannot be the sole method of contraception. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
* Poorly controlled diabetes mellitus or hypertension (e.g., systolic > 180 mmHg or diastolic > 100 mmHg).
* Inability or unwillingness to swallow oral medications.
* Clinically significant gastrointestinal abnormality that would affect the absorption of drug such as gastrointestinal dysfunction, malabsorption syndrome, major resection of the small bowel or total gastrectomy or inflammatory bowel disease.
* Uncontrolled hydropericardium.
* Chemotherapy or radiotherapy within 14 days prior to starting study treatment. In case of monoclonal antibodies/biologics, within 28 days prior to starting study treatment.
* Administration of investigational agents within 28 days prior to treatment initiation.
* Major surgery and surgery for brain metastases within 28 days prior to screening start. Of note, Intravenous port placement is not considered as a major surgery.
* Not recovered from AEs or toxicities due to previous treatments to a Grade 1 or less specified in NCI-CTCAE version 4.0 excepting, albumin (< 2.5 g/dL), AST and ALT in patients with liver metastases (> 5 × ULN) ALP in patients with bone metastases (> 5 × ULN) and alopecia.
* Prior use of a drug targeting FGF or FGFR. Patients previously treated with medications that affect FGFR signaling as a secondary target (e.g., multi-tyrosine kinase inhibitors that primarily inhibit VEGF, but to a lesser extent also affect FGFR signaling) can be considered after discussion with the Principal Investigator.
* Currently under alcohol or drug abuse rehabilitation or treatment program.
* Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility Note: Patients could have progressed on prior aromatase inhibitors
|
NCT_ID
NCT03344536
|
Study_NameA Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer
| 15,087 |
Study Objectives
Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.
Conditions: Carcinoma, Hepatocellular
Intervention / Treatment:
DRUG: Sorafenib (Nexavar, BAY43-9006), DRUG: Placebo
Location: Korea, Republic of, Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion Criteria:
* Male or female
* Aged of 18 and over
* Advanced hepatocellular carcinoma
Exclusion Criteria:
* History of prior systemic chemotherapy
* Failure in vital organ
|
NCT_ID
NCT00494299
|
Study_NamePhase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
| 11,774 |
Study Objectives
The purpose of this trial is to identify the tolerable dose of BI-1206 (both alone and in combination) for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody.
Conditions: B-cell Lymphoma, Chronic Lymphocytic Leukaemia, Waldenström Macroglobulinemia
Intervention / Treatment:
BIOLOGICAL: BI-1206 single agent dose escalation phase, BIOLOGICAL: Combination of BI-1206 with rituximab escalation phase, BIOLOGICAL: BI-1206 single agent expansion phase, BIOLOGICAL: Combination of BI-1206 with rituximab expansion phase
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
* B-cell lymphoma or CLL proven by histology or flow cytometry, relapsed or refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient. Patients should have received at least one line of conventional previous therapy which must have included a rituximab based regimen.
* CD32b positive malignancy as demonstrated centrally by immunohistochemistry or flow cytometry prior to study entry. Available tissue or blood must have been taken within six months of study entry.
* Life expectancy of at least 12 weeks.
* World Health Organisation (WHO) performance status of 0 <= age <= 2 (Appendix 1).
* Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week before their first dose of mAb (BI-1206 and/or rituximab) as part of this study.
Laboratory Test Value required
Haemoglobin (Hb) >=9.0 g/dL (red cell support is permissible)
Absolute neutrophil count (ANC) >=1.0 x 10^9/L (or >0.5 x 10^9/L if due to lymphoma), granulocyte - colony stimulating factor (G-CSF) support is not permissible at screening
Platelet count >=50 x 10^9/L (or >=30 x 10^9/L if due to malignant involvement of bone marrow)
Either:
Serum bilirubin <=1.5 x upper limit of normal (ULN) unless raised due to Gilbert's syndrome in which case up to 3 x ULN is permissible.
Or:
Alanine amino-transferase (ALT) and /or aspartate amino-transferase (AST) <= 2.5 x ULN unless raised due to malignant hepatic involvement in which case up to 5 x ULN is permissible
Either:
Calculated creatinine clearance (Cockcroft Gault) >=30 mL/min (uncorrected value)
Or:
Isotope clearance measurement >=30 mL/min (corrected)
* 18 years or over.
* B-cell lymphoma patients only: patients has at least one measurable lesion by CT scan (defined as greater than 1.5 cm in one axis) or in the case of Waldenström's macroglobulinemia, disease must be assessable by the criteria stated in Appendix 6 of the protocol.
* Patients recruited to Arm 2 in Parts A and B (combination arms) only: CD20 positive malignancy as demonstrated by immunohistochemistry or flow cytometry prior to trial entry.
Exclusion Criteria:
* Allogenic bone marrow transplant within 12 months prior to the first dose of BI-1206 or presence of chronic graft versus host disease.
* Patients with clinically active leptomeningeal or central nervous system lymphoma/leukaemia.
* Doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) are not permitted whilst on the study other than as pre-medication. During the screening period, doses of up to 20 mg per day may be given but the dose must be reduced to 10 mg/day by Cycle 1 Day 1 (or Day -7 in the CLL combination expansion).
* Known or suspected hypersensitivity to study drugs.
* Cardiac or renal amyloid light-chain (AL) amyloidosis.
* Radiotherapy, endocrine therapy, immunotherapy, chemotherapy or investigational medicinal products during the previous 4 weeks before treatment.
* Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the Sponsor should not exclude the patient.
* Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one highly effective form plus a barrier method) [oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom] or agree to sexual abstinence^4 for four weeks before entering the trial, during the trial and for twelve months after completing treatment are considered eligible.
* Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence effective from the first administration of BI-1206 or rituximab on the study, throughout the trial and for twelve months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence4). Men with pregnant or lactating partners should be advised to use barrier method contraception (e.g. condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
* Major thoracic or abdominal surgery from which the patient has not yet recovered.
* At high medical risk because of non-malignant systemic disease including infection.
* Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
* Patients with an active, known or suspected autoimmune disease (not including CLL auto-immune disease). Patients with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger will be permitted to participate.
* Concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]), prior history of cardiac ischaemia or prior history of cardiac arrhythmia.
* Patients for whom rituximab is contraindicated due to severe previous hypersensitivity or any other reason (Arm 2 in Parts A and B [combination arms] only).
* Ongoing infection requiring treatment with antibiotics, antifungals or antivirals. Prophylactic use of antibiotics, antifungals or antivirals would not have excluded patients.
* Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
* Is a participant or plans to participate in another interventional clinical study, whilst taking part in this Phase I/IIa study of BI-1206. Participation in an observational study would be acceptable.
* Current malignancies of other types, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
|
NCT_ID
NCT02933320
|
Study_NameBI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia
| 1,930 |
Study Objectives
This pilot study will investigate the use of PSMA-PET/MRI (Positron Emission Tomography/ Magnetic Resonance Imaging)to guide radiation treatment planning in patients with known or suspected locally metastatic prostate cancer at the time of diagnosis. Patients will undergo a single PSMA-PET/MRI (or PET/CT (Computed Tomography) in some circumstances) prior to initiation of treatment. Following development of a PSMA-PET guided radiation treatment plan, therapeutic radiation will be delivered per standard-of-care parameters and assessments of feasibility and tolerability will be performed.
Conditions: Metastatic Prostate Cancer
Intervention / Treatment:
DRUG: [68Ga]PSMA-PET/MRI or PET/CT
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Biopsy-proven treatment-naïve prostate adenocarcinoma with pelvic metastases known to suspected on standard-of-care staging imaging
* Eligibility and plan to undergo definitive radiation therapy for prostate cancer per established standard-of-care radiation oncology clinical guidelines
* Be at least 18 years
Exclusion Criteria:
* Inability to tolerate or undergo PET/MRI or PET/CT
* Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)
* Recurrent prostate adenocarcinoma
* Known distant metastatic disease
* Current or prior treatment for prostate cancer
* Known allergy to glucagon
* Previous diagnosis of insulinoma or pheochromocytoma
|
NCT_ID
NCT04086966
|
Study_NamePSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
| 197 |
Study Objectives
This clinical trial studies decitabine and cytarabine in treating older patients with newly diagnosed acute myeloid leukemia, myelodysplastic syndrome that is likely to come back or spread to other places in the body, or myeloproliferative neoplasm. Drugs used in chemotherapy, such as decitabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine and cytarabine may work better than standard therapies in treating cancers of the bone marrow and blood cells, such as acute myeloid leukemia, myelodysplastic syndrome, or myeloproliferative neoplasm.
Conditions: Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Untreated Adult Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Cytarabine, DRUG: Decitabine, OTHER: Laboratory Biomarker Analysis
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:
* Newly-diagnosed AML by World Health Organization (WHO) criteria (>= 20% myeloid blasts by morphology in either blood or marrow)
* High-risk myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) including chronic myelomonocytic leukemia 2 (CMML2) as defined by 10 <= age <= 19% myeloid blasts in either blood or marrow
* Patients may have received azacitidine, decitabine, or lenalidomide but no "cytotoxic therapy" such as ara-C or anthracyclines; data suggest that failure to respond to azacitidine reduces probability of response to 3+7; hence in the interest of having a relatively homogeneous population, while patients who have received and failed azacitidine or decitabine will be eligible for this study, they will be analyzed separately from patients who have not received these drugs
* Treatment related mortality (TRM) score < 22.9; patients with TRM scores > 13.1, in whom the risk of death within 28 days of beginning induction therapy has averaged 41%, will preferentially be placed on protocol 2642
* Provision of written informed consent
* Note, unlike pharmaceutical company sponsored protocols eligibility is not conditioned on bilirubin, creatinine, or absence of other malignancy within the past 2 <= age <= 3 years; the TRM score incorporates creatinine and thus a high creatinine can in principle be offset by favorable values for the other covariates in the TRM score; bilirubin was not a covariate in the TRM; furthermore, in the doses we are using, dose adjustment of decitabine or ara-C is not indicated in the presence of renal or hepatic abnormalities; our broad eligibility criteria may increase the likelihood that our results will be generalizable; the inability to reproduce results of early phase AML studies has been a problem in the past
|
NCT_ID
NCT02121418
|
Study_NameDecitabine and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, or Myeloproliferative Neoplasm
| 7,777 |
Study Objectives
Background: Polycystic ovary syndrome (PCOS) is as common as 5-10% of all women in Austria. PCOS women frequently present with metabolic disturbances, hyperandrogenism and infertility. New therapy concepts are warranted. In our recent pilot study, vitamin D (vitD) supplementation significantly improved glucose metabolism and fertility. However, the efficacy of vitD administration shows individual variability indicating endogenous influences on pharmacological effects.
A recent genome-wide association study reported three loci (DHCR7, CYP2R1, and GC) associated with vitD insufficiency. Moreover, vitD receptor (VDR) gene variants have already been known to be associated with insulin resistance.
Aim: To test the hypothesis that vitD is efficient in changing metabolic parameters in PCOS and non-PCOS women longitudinally and to generate data on pharmacogenetic effects of vitD related genetic determinants adjusted for environmental factors.
Primary outcome: Change from baseline in AUCgluc after vitD treatment. Secondary outcome: To generate the hypothesis that changes in metabolic and endocrine parameters following vitD treatment are associated with vitD related gene variants.
Methods: 150 PCOS women with 25-hydroxyvitamin D (cholecalciferol, \[25(OH)D\]) levels \<30 ng/ml will be treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic variants. In addition, 150 non-PCOS women with 25(OH)D \<30 ng/ml will be treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic variants. The response to vitD supplementation in both groups will be analysed according to genotype profiles.
Significance: VitD might be a new therapeutic option without major side effects for PCOS patients. Exploring specific loci for pharmacogenetic vitD actions would open a new window for therapy modulation in PCOS and other metabolic diseases.
Conditions: Polycystic Ovary Syndrome, Healthy, Vitamin D Deficiency
Intervention / Treatment:
DRUG: Vitamin D supplementation, DRUG: Placebo
Location: Austria
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
PCOS women:
* 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
* Polycystic ovary syndrome defined by the Androgen Excess Society (AES) criteria
* Female, age of >= 18 and <45 years
* BMI status: 75 PCOS women with BMI <=25 kg/m² and 75 PCOS women with BMI>25 kg/m²
* Written informed consent before study entry
Control women:
* 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
* Female, age of >= 18 and <45 years
* BMI status: 75 nonPCOS women with BMI <=25 kg/m² and 75 nonPCOS women with BMI>25 kg/m²
* Written informed consent before study entry
Exclusion Criteria:
PCOS women:
* Hypercalcemia defined as a serum calcium > 2,7 mmol/L
* Pregnancy or lactating women
* Disorders associated with androgen excess and/or menstrual irregularities apart from PCOS (thyroid dysfunction, hyperprolactinemia, adrenal hyperplasia, androgen secreting tumors)
* Prevalent type 2 diabetes
* Regular intake of vitD supplements at any time before study entry
* Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, oral contraceptives, ...) in the last 3 months before study entry
Control women:
* Hypercalcemia defined as a serum calcium > 2,7 mmol/L
* Established PCOS or any of the AES criteria 29 (hyperandrogenism (clinical and/or biochemical), oligo- or anovulation, or polycystic ovaries on ultrasound)
* Disorders associated with androgen excess and/or menstrual irregularities apart from PCOS (thyroid dysfunction, hyperprolactinemia, adrenal hyperplasia, androgen secreting tumors)
* Prevalent type 2 diabetes
* Pregnancy or lactating women
* Regular intake of vitD supplements at any time before study entry
* Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, oral contraceptives, ...) in the last 3 months before study entry
|
NCT_ID
NCT01721915
|
Study_NameVitamin D Treatment, Pharmacogenetics and Glucose Metabolism
| 19,315 |
Study Objectives
The purpose of this study is to learn more about ways to prevent or delay relapse of multiple myeloma (MM). This study will determine the best dosing schedule of LBH589 maintenance therapy as well as the safety (side effects) and tolerability of LBH589 maintenance therapy after autologous hematopoietic cell transplant (HCT).
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Panobinostat
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Adult patients, age >= 18 years
* Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Histologically confirmed diagnosis of multiple myeloma
* Meeting the Criteria for Symptomatic Multiple Myeloma (CRAB criteria) before the initiation of systemic chemotherapy
* Received high-dose melphalan (>= 140 mg/m^2) followed by autologous HCT based on the institutional guidelines and within +45 and +180 after autologous HCT at the time of panobinostat maintenance initiation
* Must have achieved at least partial response (PR) prior to autologous HCT and must not have progressive disease (PD) prior to the initiation of maintenance therapy
* Must meet the following laboratory criteria (prior to the initiation of panobinostat maintenance): Absolute neutrophil count (ANC) >= 1 x 10^9/L; Hemoglobin >= 8 g/dl; Platelets >= 50 x 10^9/L (without transfusion support); Creatinine clearance >= 40 ml/min or serum creatinine <= 2.5 x upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN; Serum bilirubin <= 1.5 x ULN; Albumin > 3.0 g/dl; Clinically euthyroid. Note: Participants are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
* Baseline (pre-HCT) multigated acquisition (MUGA) or echocardiogram (ECHO) must demonstrate left ventricular ejection fraction (LVEF) >= the limit of normal (LLN) of the institutional normal
* Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2 or Karnofsky performance status >= 70%
* Prior histone deacetylase (HDAC), deacetylase (DAC), HSP90 inhibitors or valproic acid for the treatment of cancer is allowed
Exclusion Criteria:
* Potential participants who have purely non-secretory multiple myeloma (i.e., the absence of a measurable protein in serum by electrophoresis and immunofixation and the absence of Bence-Jones protein in the urine defined by use of electrophoresis and immunofixation)
* Prior allogeneic HCT
* Prior solid organ transplant requiring immunosuppressive therapy
* Potential participants who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
* Impaired cardiac function or clinically significant cardiac diseases
* Diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
* Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
* Using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
* Have received targeted agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is longer) and who have not recovered from side effects of those therapies.
* Have received either immunotherapy within < 8 weeks; chemotherapy within < 4 weeks; or radiation therapy to > 30% of marrow-bearing bone within < 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
* Have undergone major surgery <= 4 weeks prior to starting study drug or have not recovered from side effects of such therapy
* Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control. WOCBP must have a negative serum pregnancy test within 24 hours of receiving the first dose of study medication.
* Male patients whose sexual partners are WOCBP not using effective birth control
* A prior malignancy with in the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)
* Known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
* Any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff
|
NCT_ID
NCT02722941
|
Study_NamePanobinostat (LBH589): Multiple Myeloma - Autologous Hematopoietic Cell Transplantation (HCT)
| 8,004 |
Study Objectives
The primary objective of this study is to confirm the safety profile of alemtuzumab 30 mg (the US/European Union (EU) approved dose) in Japanese patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL).
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Intervention / Treatment:
DRUG: alemtuzumab
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* B-cell Chronic Lymphocytic Leukemia (B-CLL) according to the 1996 National Cancer Institute-sponsored Working Group (NCI-WG) Criteria
* One or more, but <= 3 previous treatment regimens for Chronic Lymphocytic Leukemia (CLL)
* Patient requires treatment for CLL (Rai stage III and IV disease or stage 0 to II disease with evidence of progression)
* Adequate bone marrow, liver and renal function
* More than 4 weeks since prior chemotherapy or chemoimmunotherapy, including investigational agents, for the treatment of CLL. Patient must have recovered from the acute side effects incurred as a result of previous therapy
* World Health Organization (WHO) Performance Status (PS) 0,1
* Life expectancy of at least 24 weeks
* Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 2 weeks after the completion of trial
* Written informed consent
Exclusion Criteria:
* Known human immunodeficiency virus (HIV) seropositivity
* Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies. Patients with a positive hepatitis B surface antibody (HBsAb) test with a documented history of prior hepatitis B immunization are eligible as long as other criteria are met (i.e., negative tests for : hepatitis B surface antigen [HBsAg], hepatitis B core antibody [HBcAb] and hepatitis C virus antibody [HCVAb])
* Active uncontrolled infection
* Recent documented history (within 2 years) of active tuberculosis (TB), current active TB infection, currently receiving anti-tuberculous medication (e.g., isoniazid, rifampin, streptomycin, pyrazinamide, or others)
* Positive cytomegalovirus (CMV) by Polymerase Chain Reaction (PCR) assay
* Transformation to aggressive lymphoma (e.g., Richter's syndrome)
* Past history of anaphylaxis following exposure to humanized monoclonal antibodies
* Previous treatment with alemtuzumab
* Previous hematopoietic stem cell transplant
* Pregnant or breast-feeding patients
* Central nervous system (CNS) involvement with CLL
* Other severe, concurrent diseases (e.g., cardiac or pulmonary disease), mental disorders, or major organ malfunction (e.g., liver, kidney) that could interfere with the patient's ability to participate in the study
* Medical condition requiring chronic use of oral corticosteroids at a dose higher than physiologic replacement.
* Active malignancy, other than CLL, which needs therapy with anti-cancer drug(s)
* Autoimmune anemia and/or thrombocytopenia
* Small lymphocytic lymphoma
|
NCT_ID
NCT00923182
|
Study_NameA Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
| 2,327 |
Study Objectives
The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors.
The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.
Conditions: Carcinoma
Intervention / Treatment:
DRUG: Sorafenib 100 mg (50-mg tablet), DRUG: Sorafenib 200 mg (50-mg tablet), DRUG: Sorafenib 400 mg (50-mg tablet), DRUG: Sorafenib 400 mg (200-mg tablet), DRUG: Sorafenib 400 mg (Expansion)
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:
* Histologically confirmed solid tumors
* Evaluable disease
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Life expectancy minimum 12 weeks
Exclusion Criteria:
* Congestive heart failure
* Serious arrhythmias
* Coronary artery disease (CAD) or ischemia
* HIV (human immunodeficiency virus)
* Hepatitis B or C
* Serious active infection
* Metastatic brain or meningeal tumors
|
NCT_ID
NCT00941863
|
Study_NameStudy to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
| 4,389 |
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