Search is not available for this dataset
data
stringlengths 198
8.94k
| criteria
stringlengths 19
16.5k
| NCT_ID
stringlengths 19
19
| Study_Name
stringlengths 29
311
| __index_level_0__
int64 0
22.6k
|
|---|---|---|---|---|
Study Objectives
It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.
Conditions: Follicular Lymphoma
Intervention / Treatment:
DRUG: Rituximab
Location: Germany
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Age > 18 years
* Previously untreated, relapsed or refractory CD 20-positive FL
* Responding to rituximab containing induction therapy (complete response [CR] or partial response [PR])
* To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
* No ineligibility for rituximab
Exclusion Criteria:
Not Applicable (NA)
|
NCT_ID
NCT02536664
|
Study_NameNon-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
| 12,688 |
Study Objectives
This is a window of opportunity study for patients with resectable squamous cell carcinoma of the oral cavity who are considered suitable for curative-intent surgical resection, with pre-operative drugs, Sitravatinib and Nivolumab.
Conditions: Squamous Cell Carcinoma, Head And Neck, Squamous Cell Carcinoma Mouth, Squamous Cell Carcinoma of the Oral Cavity
Intervention / Treatment:
DRUG: Sitravatinib, BIOLOGICAL: Nivolumab
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Signed written and voluntary informed consent.
* Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
* Age > 18 years, male or female.
* Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oral cavity (SCCOC) (floor of mouth, anterior 2/3 tongue, buccal mucosa, upper and lower gingiva, retromolar trigone and hard palate) previously untreated, considered resectable by the head and neck treating surgeon (T2 <= age <= 4a, N0 <= age <= 2, or T1 - greater than 1 cm - N2, M0; without evidence of distant metastasis).
* Patient must be willing and able to provide 2 fresh tumor biopsies for histopathological and biomarker evaluation: one at baseline and one after treatment with Sitravatinib but prior to treatment with Nivolumab. Archival tissue sample will be requested if available.
* No anti-neoplastic treatment is allowed between the time from obtaining baseline tumor specimen and enrollment.
* ECOG performance status 0 <= age <= 1.
* Patient must have adequate organ function as determined by the following:
* Renal function: i. Serum creatinine < 1.5 ULN (upper limit of normal range) or a calculated creatinine clearance of > 50mL/min using the following formula:
Creatinine clearance = [(140-age) x wt (kg) x Constant*] / creatinine (umol/L)
*Constant = 1.23 for men, and 1.04 for women
* Bone marrow function (without hematopoietic growth factors or transfusion): i. Absolute neutrophil count (ANC) > 1.0 x 109/L ii. Leukocytes > 2.0 x 109/L iii. Hemoglobin > 90 g/L or > 9g/dL iv. Platelets > 100 x 109/L
* Liver function: i. Total bilirubin <= 1.5 x ULN or <= 3 x ULN for patients with Gilbert Syndrome. ii. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) < 2.5 x ULN
* Cardiac function: i. A normal left ventricular ejection fraction (LVEF) of >=50% by a MUGA scan performed within 4 weeks of the study commencement.
* Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
* Women <50 years would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
* Women >=50 years would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). Women of child-bearing potential (WOCBP) or men whose partner is a WOCBP agrees to use contraception while participating in this study, and for a period of 6 months following termination of study treatment.
* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Exclusion Criteria:
* Primary site of head and neck carcinoma unknown, lip, skin, or outside the oral cavity.
* Patients with tumors that invade major vessels or are within <= 3 mm of the carotid artery as shown unequivocally by imaging studies.
* Patients with any prior history of clinically significant bleeding related to the current head and neck cancer.
* Patients with a history of gross hemoptysis (bright red blood of ½ teaspoon or more per episode of coughing) < 3 months prior to enrollment.
* Prior or concurrent radiation therapy to tumor at site of planned resection.
* Any concurrent chemotherapy, biologic, immunologic or hormonal therapy for cancer treatment.
* Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.
* Current or prior use of immunosuppressive medication within 14 days prior to starting dosing. The following are exceptions to this criteria:
* Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection).
* Adrenal replacement steroid > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
* Steroids as premedication for hypersensitivity reactions (eg, computed tomography scan premedication).
* Active or documented history of autoimmune disease within 2 years before screening, including:
* Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis).
* Patients with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, Grave's disease, Hashimoto's disease, or psoriasis not requiring systemic steroids and/or immunosuppressive agents within the past 2 years, are not excluded.
* History of primary immune deficiency.
* History of stroke or transient ischemic attack within the previous 6 months.
* History of uncontrolled hypertension (> 150 mm Hg systolic or > 100 mm Hg diastolic) on multiple observations despite standard of care treatment.
* Any of the following cardiac abnormalities:
* Unstable angina pectoris,
* Congestive heart failure >= NYHA Class 3,
* QTc >480 milliseconds,
* Left ventricular ejection fraction (LVEF) < 50.
* Concomitant medication known to cause prolonged QT that cannot be discontinued or changed to a different medication prior to enrollment.
* History of organ transplant that requires use of immunosuppressive medications.
* Known allergy or reaction to any components of Sitravatinib and/or Nivolumab formulation.
* Subjects who are known to be human immunodeficiency (HIV) positive.
* Has a known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (defined as HCV RNA [qualitative] is detected).
* HBV DNA must be undetectable and HBsAg negative at Screening Visit.
* Participants who have had definitive treatment for HCV are permitted if HCV RNA is undetectable at Screening Visit.
* Female patients who are pregnant or breast-feeding.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active clinically significant infection requiring parenteral antibiotics, unstable cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events from Sitravatinib or Nivolumab, or compromise the ability of the subject to give written informed consent.
* Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results.
* Any previous treatment with a PD1 or PD-L1 inhibitor, including Nivolumab.
* History of another primary malignancy, except for:
* Malignancy treated with curative intent and with no known active disease >=3 years before the first dose of study drug and of low potential risk for recurrence,
* Adequately treated non-melanoma skin cancer without evidence of disease,
* Adequately treated carcinoma in situ without evidence of disease.
* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study medications.
* Any prior Grade >=3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1.
|
NCT_ID
NCT03575598
|
Study_NameSitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study
| 20,602 |
Study Objectives
The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion).
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: JNJ-26866138 0.7 mg/m2, DRUG: JNJ-26866138 1.0 mg/m2, DRUG: JNJ-26866138 1.3 mg/m2, DRUG: Melphalan, DRUG: Prednisolone
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Participants diagnosed with symptomatic or nonsecretory multiple myeloma
* Participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates
* Participants with a measurable lesion
* Life expectancy greater than or equal to 3 months
Exclusion Criteria:
* Previously received treatment for Multiple Myeloma
* Greater than or equal to Grade 2 peripheral neuropathy or neuropathic pain
* Myocardial infarction within 6 months prior to enrollment or uncontrolled angina, severe uncontrolled ventricular arrhythmias, or clinically significant conduction system abnormalities
* Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection
* Active prior malignancy diagnosed within the last 5 years
* Female participant who is pregnant or breast-feeding
* Participant is enrolled in another clinical research study and/or is receiving an investigational agent
|
NCT_ID
NCT00985959
|
Study_NameA Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
| 11,447 |
Study Objectives
This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve \[AUC\]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Bevacizumab, DRUG: Carboplatin, DRUG: Gemcitabine
Location: India
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Female participants, >= 18 years
* Metastatic breast cancer
* Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative disease
* Treatment-naïve for metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2
* Adequate hematological, renal and liver function
* Patients should have received Anthracyclines and Taxanes in the adjuvant setting
* Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products
Exclusion Criteria:
* Prior first line treatment for metastatic breast cancer
* Central nervous system (CNS) metastasis
* Uncontrolled hypertension (> 170/95 mmHg)
* Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
* Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
* Prior therapy with gemcitabine or carboplatin in the metastatic setting. Participants having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented >6 months after the last exposure to the drug(s)
* Requirement of chronic use of immunosuppressive agents
* HIV, hepatitis B or hepatitis C infection
|
NCT_ID
NCT01201265
|
Study_NameA Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer
| 202 |
Study Objectives
The main purpose of this study is to examine the safety and tolerability of CDX-1401 when given in combination with an immune stimulant (resiquimod) to patients with advanced cancers that are known to express the NY-ESO-1 protein.
Conditions: Advanced Malignancies
Intervention / Treatment:
BIOLOGICAL: CDX-1401 in combination with Resiquimod and/or Poly-ICLC, BIOLOGICAL: CDX-1401, BIOLOGICAL: Resiquimod, BIOLOGICAL: poly-ICLC
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:
Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:
* 18 years or older.
* Have a cancer type that is known to express NY-ESO-1, including (but not limited to) cancer of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma or melanoma.
* Have cancer that has progressed after any therapies with curative potential or approved salvage therapies (if such therapies exist).
* Have evaluable or measurable tumors.
* Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
* Have a sample of tumor tissue available for NY-ESO-1 testing at a central laboratory.
* If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.
Exclusion Criteria:
Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:
* Are receiving treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (inhaled or topically applied steroids are permitted).
* Has a known infection with HIV, HBV or HCV, or any other active infection requiring systemic antibiotic treatment.
* Has active central nervous system tumors.
* Any underlying medical condition that in the Principal Investigator's opinion will make the administration of study drug hazardous or otherwise interfere with the study.
|
NCT_ID
NCT00948961
|
Study_NameA Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
| 19,894 |
Study Objectives
The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory Hodgkin's disease. The safety of this study treatment will also be studied.
Conditions: Lymphoma
Intervention / Treatment:
DRUG: Gemcitabine, DRUG: Busulfan, DRUG: Melphalan, PROCEDURE: Stem Cell Transplantation, DRUG: Palifermin
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:
* Age 12 <= age <= 70
* Patients with relapsed Hodgkin's disease and one or more of the following: 1) Less than complete response to first-line chemotherapy, 2) Relapse within 12 months of completion of first-line chemotherapy, 3) Relapse within a prior irradiation field, 4) Less than complete metabolic response to second-line chemotherapy, 5) Second relapse or beyond, 6) Extranodal disease at the time of relapse, 7) Presence of B symptoms at the time of persistent disease upon completion of first-line chemotherapy, or of relapse, progressive disease, 8) Bulky disease (defined as any lesion greater than 5 cm) at the time of persistent disease upon completion of first-line chemotherapy, or of relapse, progressive disease.
* Adequate renal function, as defined by estimated serum creatinine clearance >=50 ml/min (using the Cockcroft-Gault formula: creatinine clearance = [(140-age)*kg/(72*serum creatinine)] * 0.85 if female) and/or serum creatinine <=1.8 mg/dL.
* Adequate hepatic function, as defined by SGOT and/or SGPT <=3 x upper limit of normal; serum bilirubin and alkaline phosphatase <=2 x upper limit of normal, unless due to disease involvement
* Adequate pulmonary function with FEV1, FVC and DLCO >=50% of expected corrected for hemoglobin and/or volume.
* Adequate cardiac function with left ventricular ejection fraction >=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
* Zubrod performance status <2.
* Negative Beta HCG text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Exclusion Criteria:
* Patients with grade >= 3 non-hematologic toxicity from previous therapy that has not resolved to <= grade 1.
* Patients with prior whole brain irradiation
* Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >=10,000 copies/mL, or >= 2,000 IU/mL).
* Evidence of either cirrhosis or stage 3 <= age <= 4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
* Active infection requiring parenteral antibiotics.
* HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts
* Patients having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment.
|
NCT_ID
NCT01200329
|
Study_NameHigh-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease
| 4,931 |
Study Objectives
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Sagopilone (ZK 219477) + prednisone
Location: United States, Argentina
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Must have evidence of confirmed metastatic prostate cancer
* Serum testosterone must be less than 50 ng/mL
* Disease must be progressing despite anti-androgen therapy
* PSA level must be elevated
* Additional criteria determined at screening visit
Exclusion Criteria:
* Any previous cytotoxic chemotherapy for prostate cancer
* Use of any investigational drug in the last 4 weeks
* Symptomatic brain tumors requiring radiation to the brain
* Active infection
* Additional criteria determined at screening visit
|
NCT_ID
NCT00350051
|
Study_NameZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer
| 21,919 |
Study Objectives
To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)
Conditions: Lymphoma, Follicular
Intervention / Treatment:
DRUG: Ofatumumab, DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Prednisolone, Prednisone or equivalent
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patient with Follicular Lymphoma (FL)
* Confirmed diagnosis of Follicular lymphoma
* 18 years or above
* Verbal and written information about the study
Exclusion Criteria:
* No previous treatment for Follicular Lymphoma
* Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma
* Several diseases such as malignancies etc.
* Screening laboratory values
* Current participation in any other interventional clinical study
* Breast feeding women or pregnant women
* Women of childbearing potential not willing to use adequate contraception
|
NCT_ID
NCT00494780
|
Study_NameOfatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients
| 5,791 |
Study Objectives
The hypothesis in this study is that estrogen suppression by an aromatase inhibitor in postmenopausal women with lymphangioleiomyomatosis (LAM) will prevent or delay progression of lung disease and result in a decrease in the rate of decline in FEV1
Conditions: Lymphangioleiomyomatosis
Intervention / Treatment:
DRUG: Letrozole, DRUG: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion Criteria:
* Definite diagnosis of based on compatible chest CT and at least one of the following:
1. biopsy or cytology consistent with LAM, or
2. tuberous sclerosis, renal angiomyolipoma, cystic abdominal lymphangiomas, or chylous effusion in the chest or abdomen, or
3. serum VEGF-D >= 800 pg/uL.
* post bronchodilator FEV1 <=80% predicted or DLCO <=70% predicted or RV>=120% predicted
* female and postmenopausal status as defined by one of the following:
1. prior bilateral oophorectomy or bilateral ovarian irradiation, or
2. age greater than 55 years, and no menstrual period for 12 months or longer.
3. age 18 <= age <= 55 years and estradiol level in the postmenopausal range in the absence of current use of progestational agents.
* If still premenopausal, may enter if rendered medically postmenopausal on clinical grounds with the use of gonadotropin releasing hormone (e.g. leuprolide), as long as serum estradiol, FSH, and LH are in the postmenopausal range
* Patients with osteopenia or osteoporosis must be receiving appropriate treatment for their osteoporosis or osteopenia at entry into this study.
Exclusion Criteria:
* Known allergy to letrozole
* Inability to comply with pulmonary function tests or follow up visits.
* Treatment with investigational agents within 30 days
* Hormonal therapy (e.g. estrogen, progestin, LHRH agonists or antagonists, estrogen receptor blockers, estrogen receptor down regulators, aromatase inhibitors) within 30 days month of registration
* Medical or psychiatric conditions that would interfere with the ability to provide informed consent.
* abnormal hematologic and hepatic function as defined by the following at the time of randomization.:
* Neutrophils < 1500/mm3 and platelets < 100,000/mm3
* Bilirubin < 1.25 X upper limit of normal
* SGPT (ALT) or SGOT (AST) >2.5 X upper limit of normal
|
NCT_ID
NCT01353209
|
Study_NameLetrozole for Lymphangioleiomyomatosis
| 18,091 |
Study Objectives
Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well panobinostat works in treating patients with relapsed or refractory non-Hodgkin lymphoma
Conditions: Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Peripheral T-cell Lymphoma, Post-transplant Lymphoproliferative Disorder, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia
Intervention / Treatment:
DRUG: panobinostat, OTHER: laboratory biomarker analysis, GENETIC: western blotting, GENETIC: DNA analysis, OTHER: flow cytometry, OTHER: pharmacological study, OTHER: immunohistochemistry staining method
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 relapsed or refractory non-Hodgkin lymphoma requiring treatment, who have failed, unable to tolerate, or refused other available active therapies; patients should not have other treatment options considered curative (NOTE: for patients with lymphoma without CNS involvement, a re-biopsy is necessary unless the patient has had a previous biopsy =< 6 months prior to treatment on this protocol if there has been no intervening treatment; patients with biopsy-proven CNS lymphoma at any time are not required to have a rebiopsy to be eligible for this study); NOTE: relapsed NHL is defined as NHL that relapses after at least one prior therapy and does not have available curative therapy; refractory NHL is defined as NHL that has progressed or not responded to most recent therapy and has had at least one prior therapy and have no available curative therapies
* Measurable disease by CT or MRI or the CT portion of the PET/CT: must have at least one lesion that has a single diameter of >= 2 cm or tumor cells in the blood >= 5 x 10^9/L; skin lesions can be used if the area is >= 2 cm in at least one diameter and photographed with a ruler
* The following disease types are eligible: transformed lymphomas: diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma grade III; precursor B lymphoblastic leukemia/lymphoma; mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma/leukemia; precursor T-lymphoblastic leukemia/lymphoma; primary cutaneous anaplastic large cell lymphoma; anaplastic large cell lymphoma - primary systemic type; small lymphocytic lymphoma/chronic lymphocytic leukemia; follicular lymphoma, grades 1, 2; extranodal marginal zone B-cell lymphoma of MALT type; nodal marginal zone B-cell lymphoma; splenic marginal zone B-cell lymphoma; peripheral T cell lymphoma, unspecified; anaplastic large cell lymphoma (T and null cell type); lymphoplasmacytic lymphoma (Waldenstrom Macroglobulinemia); CNS lymphoma; post transplant lymphoproliferative disorders; mycosis fungoides/Sezary syndrome; primary effusion lymphoma; blastic NK-cell lymphoma; adult T-cell leukemia/lymphoma; extranodal NK/T-cell lymphoma, nasal type; enteropathy-type T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma - primary cutaneous type
* For lymphoplasmacytic lymphoma patients without measurable lymphadenopathy, measurable disease can be defined by both of the following criteria: bone marrow lymphoplasmacytosis with > 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy and quantitative IgM monoclonal protein > 1,000 mg/dL
* ANC >= 1000/uL
* Hgb >= 9 g/dl
* PLT >= 75,000/uL
* Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be normal
* AST =< 3 x ULN
* Albumin > 3.0 g/dl
* Creatinine =< 2.5 x ULN
* Serum potassium, magnesium and phosphorus >= LLN and =< 1.2 x ULN
* Total serum calcium [corrected for serum albumin] or ionized calcium >= LLN
* Clinically euthyroid; patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism
* Baseline MUGA or ECHO must demonstrate LVEF >= the lower limit of the institutional normal
* Ability to understand and the willingness to sign a written informed consent document
* Willingness to return to Mayo Clinic
* Life expectancy >= 12 weeks
* Willingness to provide blood and tissues samples for research studies as required by the protocol
* Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
* ECOG performance status (PS) 0, 1 or 2
Exclusion Criteria
* Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
* Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
* Candidate for known standard therapy for the patient's disease that is potentially curative
* Uncontrolled infection requiring ongoing antibiotics
* Any prior therapy for lymphoma within the previous 2 weeks for standard treatments and within 4 weeks for experimental therapies unless the patient has recovered from the nadir of the previous treatment to a level that meets the inclusion criteria
* Receiving corticosteroids > 20mg of prednisone per day (or equivalent)
* Persistent toxicities >= grade 2 from prior chemotherapy or biological therapy regardless of interval since last treatment
* Patients with congenital long QT syndrome
* History or presence of sustained ventricular tachyarrhythmia (patients with a history of atrial arrhythmia are eligible but should be discussed with the study PI prior to enrollment)
* Any history of ventricular fibrillation or torsade de pointes
* Bradycardia defined as HR < 50 bpm; patients with pacemakers are eligible if HR >= 50 bpm
* Screening ECG with a QTcFredericia (QTcF) > 450 msec
* Right bundle branch block + left anterior hemiblock (bifascicular block)
* Patients with myocardial infarction or unstable angina =< 6 months prior registration
* Other clinically significant heart disease (e.g. CHF NY Heart Association class III or IV, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
* Pregnant women or women of reproductive ability who are unwilling to use effective contraception during the study and for 3 months after stopping treatment
* Nursing women
* Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 3 months after stopping treatment
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation); patients should have recovered from any immunotherapy, chemotherapy, or radiation therapy related toxicities
* Known positivity for human immunodeficiency virus (HIV) or hepatitis C with uncontrolled disease; baseline testing for HIV and hepatitis C is not required
* Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
* Inability to swallow or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drugs (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea > CTCAE Grade 2, malabsorption syndrome or small bowel resection) that would preclude use of oral medications
* Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
* Any severe and/or uncontrolled medical conditions or other conditions that, in the treating physician's opinion, could adversely impact their ability to participate in the study; patients on chronic oxygen therapy, those with liver disease such as cirrhosis, chronic hepatitis or chronic persistent hepatitis, or uncontrolled infections will be excluded
* Concomitant use of strong or moderate CYP3A4 inhibitors
* 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
* Active bleeding tendency. NOTE: Patients on therapeutic anticoagulation should be monitored carefully to maintain therapeutic level of anticoagulation to avoid increased risk of bleeding due to concurrent drug induced thrombocytopenia. It is suggested that patients who require anticoagulation therapy while on therapy use low molecular weight heparin (LMWH).
* Major surgery =< 4 weeks prior to registration or have not recovered from side effects of such therapy
* History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer or early stage prostate cancer
|
NCT_ID
NCT01261247
|
Study_NamePanobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
| 21,556 |
Study Objectives
The purpose of this study is to evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary evaluation of the efficacy of this three drug regimen in the initial treatment of these patients.
Conditions: Ovary Cancer
Intervention / Treatment:
DRUG: Topotecan, DRUG: Paclitaxel, DRUG: Carboplatin
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
* Epithelial ovarian carcinoma or primary peritoneal carcinoma
* Willing to consider second-look surgery to evaluate response if necessary
* No previous treatment with chemotherapy or radiation therapy
* Ability to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney function
* Written informed consent
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
* Age < 18 years
* Brain metastases
* Recent history of significant heart disease within 6 months
* Other significant medical conditions
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
NCT00193297
|
Study_NameTopotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
| 21,633 |
Study Objectives
The purpose of this study is to compare two preoperative chemotherapy regimens based on high-dose methotrexate courses given alternately either with doxorubicin or with etoposide-ifosfamide.
Conditions: Osteosarcoma, Localised High Grade Osteosarcoma of the Limbs
Intervention / Treatment:
DRUG: Etoposide, Ifosfamide, Methotrexate, DRUG: Doxorubicin, Methotrexate
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* non metastatic limb osteosarcoma,
* age less than 20 years,
* biopsy proven high-grade osteosarcoma,
* no previous treatment,
* no contraindication to chemotherapy
* no previous malignancy,
* Written informed consent.
Exclusion Criteria:
* juxta-cortical sarcoma and microcellular anaplastic sarcoma,
* previous anticancer treatment
* contraindication to chemotherapy
* previous malignancy,
|
NCT_ID
NCT00180908
|
Study_NameComparison of High-Dose Methotrexate (HDM) Plus Doxorubicin to HDM Plus Etoposide-Ifosfamide in Osteosarcoma Children
| 13,949 |
Study Objectives
This phase Ib trial studies the side effects and best doses of carfilzomib and bendamustine hydrochloride when given together with dexamethasone in treating patients with multiple myeloma that has returned or does not respond to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work to stop the growth of cancer cells by killing the cells. Biological therapies, such as dexamethasone, may stimulate the immune system and stop cancer cells from growing. Giving carfilzomib, bendamustine hydrochloride, and dexamethasone may be a better way to treat multiple myeloma.
Conditions: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Intervention / Treatment:
DRUG: Bendamustine Hydrochloride, DRUG: Carfilzomib, DRUG: Dexamethasone, OTHER: Laboratory Biomarker Analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Relapsed and or refractory multiple myeloma after at least one prior line of therapy; there is no upper limit of prior lines of therapy; patients who are ineligible for stem cell transplantation are allowed; patients should have received at least one prior novel agent (immunomodulatory agents or proteasome inhibitors); patients eligible for bone marrow transplant must have undergone bone marrow transplant (BMT) prior to enrollment
* Measurable disease, as defined by one or all of the following (assessed within 30 days prior to initiation of therapy): a) serum M-protein >= 0.5 g/d; b) urine Bence-Jones protein >= 200 mg/24 hours; c) patients with light chain only myeloma are eligible; the involved free light chain level 100 mg/L with abnormal serum free light chain ratio
* Documented relapse or progressive disease on or after any regimen (subjects refractory to the most recent regimen are eligible)
* Primary refractory patients (never responded to any therapy) are eligible
* Eastern Cooperative Oncology Group performance status 0 - 2
* Serum alanine aminotransferase (ALT) < 3.5 times the upper limit of normal within 30 days prior to cycle 1 day 1
* Serum direct bilirubin < 2 mg/dL (34 Omol/L) within 30 days prior to cycle 1 day 1
* Absolute neutrophil count (ANC) >= 1.0 x 10^9/L within 30 days prior to cycle 1 day 1, without granulocyte-colony stimulating factor (G-CSF)
* Hemoglobin > 9 g/dL (80 g/L) within 30 days prior to cycle 1 day 1 (subjects may be receiving red blood cell transfusions in accordance with institutional guidelines)
* Platelet count > 100 x 10^9/L (30 x 10^9/L if myeloma involvement in the bone marrow aspirate is > 50%) within 30 days prior to cycle 1 day 1; subjects may receive platelet transfusions within institutional guidelines
* Creatinine clearance > 50 mL/minute within 30 days prior to cycle 1 day 1, either measured or calculated using a standard formula
* Patient should have a normalized or normal uric acid level prior to study entry
* Written informed consent in accordance with federal, local, and institutional guidelines
* Females of childbearing potential must have a negative pregnancy test and agree to ongoing pregnancy testing and to practice contraception; (birth control methods should be determined in consultation with the investigator)
* Male subjects must agree to practice contraception
Exclusion Criteria:
* Intolerance to previous bendamustine, carfilzomib or dexamethasone or mannitol; subjects who are allergic to bortezomib are not excluded
* Chemotherapy (approved or investigational) within 3 weeks prior to the first day of treatment or antibody therapy within 6 weeks prior to the first day of treatment
* Radiotherapy to >= 3 sites at the same time within 1 week prior to the first day of treatment
* Immunomodulatory therapy such as immunomodulatory drugs (Imids) or stem cell transplant within 28 days prior to the first day of treatment
* Pregnant or lactating females
* Major surgery within 21 days prior to the first day of treatment
* Acute active infection requiring treatment (IV antibiotics, antivirals, or antifungals) within 14 days prior to the first day of treatment
* Known human immunodeficiency virus infection
* Known active hepatitis B or C infection
* Unstable angina or myocardial infarction within 4 months prior to the first day of treatment, the New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities unless subject has a pacemaker
* Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to the first day of treatment
* Non-hematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
* Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to the first day of treatment
* Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
* Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment
* Subjects with known or likely systemic amyloidosis
* Ongoing graft-vs-host disease
* Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to the first day of treatment
* Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
|
NCT_ID
NCT02095834
|
Study_NameCarfilzomib, Bendamustine Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
| 7,392 |
Study Objectives
The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was determined in a previous the M04-710 study.
Conditions: Solid Tumor
Intervention / Treatment:
DRUG: ABT-869
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria
* Subjects aged from 20 <= age <= 75 and ECOG PS of 0 <= age <= 2 at screening.
* Subject must have a solid tumor that is refractory to standard therapies or for which a standard effective therapy does not exist.
* The subject must have adequate bone marrow, renal and hepatic function.
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and up to six months following completion of therapy.
* The subject must voluntarily sign and date an informed consent.
Exclusion Criteria
* The subject currently exhibits symptomatic or intervention indicated CNS metastasis.
* The subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within 4 weeks of enrollment or has not fully recovered from toxicity resulting from past treatment(s) that affects the assessments in this study at the enrollment.
* The subject with the following conditions during screening assessment.
1. proteinuria CTC grade > 1 as measured by urinalysis and 24 hour urine collection
2. diastolic blood pressure (BP) > 95 mmHg; or systolic blood pressure (BP) > 150 mmHg
3. a history of or currently exhibits clinically significant cancer related events of bleeding
4. LV Ejection Fraction < 50%
5. received a cumulative dose of Anthracycline > 360 mg/m2 for treatment of cancer
6. receiving therapeutic anticoagulation therapy
7. having fractures except for chronic bone lesion due to bone metastases
* The subject exhibits evidence of other clinically significant uncontrolled condition(s).
|
NCT_ID
NCT00718380
|
Study_NameA Phase 1 Study of ABT-869 in Subjects With Solid Tumors
| 5,855 |
Study Objectives
The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.
Conditions: Pancreatic Cancer, Adenocarcinoma of the Pancreas
Intervention / Treatment:
DRUG: Bevacizumab, DRUG: Erlotinib, DRUG: Gemcitabine
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:
* Previously untreated patients with unresectable or metastatic adenocarcinoma of the pancreas
* ECOG Performance Status 0 <= age <= 2
* 18 years or older
* Radiographically measurable disease
* Expected survival of at least 4 months
* Creatinine of <= 2.0
* Adequate hepatic function
* Adequate hematopoietic function
* Use of effective means of contraception in subjects of child-bearing potential
Exclusion Criteria:
* Warfarin anticoagulation
* Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor
* Coexistent malignant disease
* Current or recent (within 4 weeks) participation in a clinical trial
* Pregnancy
* Documented invasion of adjacent organs or major blood vessels
* Blood pressure of > 150/100mmHg
* Unstable angina
* NYHA Grade II or greater congestive heart failure
* History of myocardial infarction or stroke within 6 months
* Clinically significant peripheral vascular disease
* Evidence of bleeding diathesis of coagulopathy
* Presence of CNS or brain metastases
* Major surgical procedure, open biopsy, or significant traumatic event within 28 days
* Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
* Serious non-healing wound, ulcer or bone fracture
|
NCT_ID
NCT00366457
|
Study_NameGemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
| 854 |
Study Objectives
The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab, DRUG: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Investigator and subinvestigator judge a candidate is understand clinical trial and comply this protocol.
Investigator is those who participate in conducting a study and oversight the study duties at a site.
* Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment
* Aged >=20 to <80 years at the time of informed consent
* Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)
* Patients with lesion(s) that can be evaluated. It is not essential to be evaluated the tumor according to the RECIST ver. 1.1.
* Patients who have not received chemotherapy for colorectal cancer. Patients who experience relapse more than 24 weeks (168 days) after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled. Patients who have received perioperative adjuvant chemotherapy including oxaliplatin are excluded.
* Patients classified as KRAS/NRAS wild-type by KRAS/NRAS testing. KRAS/NRAS test will be performed using the in vitro diagnostic listed in the National Health Insurance.
Patients with no mutation in any of the codons shown below are considered wild type. It is not considered wild type if either of the codons are not evaluable or not tested.
KRAS: EXON2 (codon 12, 13), EXON3 (codon 59, 61), EXON4 (codon 117, 146) NRAS：EXON2 (codon 12, 13), EXON3 (codon 59, 61), EXON4 (codon 117, 146)
* Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment
* Neutrophil count >= 1.5×10^3/µL
* Platelet count >= 1.0×10^4/µL
* Hemoglobin >= 9.0 g/dL
* Total bilirubin <= 2.0 mg/dL
* AST <= 100 IU/L (<= 200 IU/L if liver metastases are present)
* ALT <= 100 IU/L (<= 200 IU/L if liver metastases are present)
* Serum creatinine <= 1.5 mg/dL
* PT-INR < 1.5 (< 3.0 for patients treated with oral warfarin)
* Satisfies at least one of these conditions
1. Urine protein (dip stick method) <= 1+
2. UPC (urine protein creatinine) ratio <= 1.0
3. Urinary protein <= 1000 mg/ 24hours
* ECOG performance status (PS) of 0 or 1
* Life expectancy of >= 3 months (90 days) after enrollment
Exclusion Criteria:
* Radiotherapy received within 4 weeks (28 days) prior to enrollment. Treatments aimed at relieving pain for bone metastases are excluded.
* Known brain metastasis or strongly suspected of brain metastasis
* Synchronous cancers or metachronous cancers with a disease-free period of <= 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.).
* Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)
* Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy
* Nonhealing surgical wound (excluding implanted venous reservoirs)
* Active hemorrhage requiring blood transfusion
* Disease requiring systemic steroids for treatment (excluding topical steroids)
* The patient who has placed colonic stent
* Intestinal resection within 4 weeks prior to enrollment or colostomy within 2 weeks prior to enrollmentt
* History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.)
* Patients with unstable angina, myocardial infarction, cerebral hemorrhage, arterial thromboembolism such as cerebral infarction, or have history of these desease less than 24 weeks (168 days) before registration (except for lacunar infarction asymptomatic)
* Serious drug hypersensitivity
* Local or systemic active infection requiring treatment, or fever indicating infection
* NYHA class II or higher heart failure or serious heart disease
* Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhoea (incapacitating symptoms despite adequate treatment)
* Poorly controlled hypertension
* Poorly controlled diabetes mellitus
* Active hepatitis B
* Known HIV infection
* Peripheral neuropathy of >= Grade 2 by CTCAE (Japanese edition JCOG version 4.03)
* Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study (e.g. Patients who might agree to participate under compulsion).
|
NCT_ID
NCT02394795
|
Study_NamePanitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC
| 13,877 |
Study Objectives
This phase II trial studies how well bortezomib works in treating patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Conditions: Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
Intervention / Treatment:
DRUG: bortezomib, 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 not have received prior myeloma specific therapy (chemotherapy, radiotherapy, or biologic therapy) other than bisphosphonate therapy
* Patients may have received radiation of plasmacytoma (for example, solitary plasmacytoma); the last such treatment must have occurred >= 4 weeks prior to registration
* Patients must be recently diagnosed with symptomatic multiple myeloma confirmed by meeting one or more of the following criteria (obtained =< 30 days prior to registration):
* NOTE: serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP) and marrow biopsy all must be done at baseline in order to evaluate response
* Monoclonal protein in the serum >= 1 g/dl (measurable disease), or
* Monoclonal light chain in the urine protein electrophoresis >= 200 mg/24 hours (measurable disease), or
* Bone marrow plasmacytosis >= 30% without either of the values in above (evaluable disease)
* Patients must meet one or more of the following (all tests must be been drawn =< 30 days prior to registration but all results are not required to be available at time of registration as long as at least one of the following criteria has been met; if patient is otherwise eligible, plasma cell labeling index [PCLI] is not required, but is requested):
* Beta-2 microglobulin >= 5.5 mcg/mL, or
* PCLI >= 1, or
* Deletion 13 by cytogenetics
* Platelet count >= 20,000/mm^3, with or without transfusion support
* Hemoglobin >= 7.0 g/dL, with or without transfusion support
* Absolute neutrophil count (ANC) >= 500/mm^3 without growth factor support
* Direct bilirubin within =< 1.5 x upper normal limits (UNL)
* Alkaline phosphatase =< 2.5 x UNL
* Aspartate aminotransferase (AST) =< 2.5 x UNL
* Calculated or measured creatinine clearance >= 20 mL/minute
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2; exception: PS = 3 if secondary to acute bone event (fracture)
* Patients may not receive concurrent chemotherapy, radiotherapy or biologic therapy while on study; the exception for corticosteroids is made for those taking chronic corticosteroids for disorders other than myeloma, such as rheumatoid arthritis, adrenal insufficiency, etc.
* NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
* Patients must not have a history of allergic reaction attributable to compounds containing boron or mannitol
* Patient must not have a peripheral neuropathy > grade 1, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 3.0):
* Grade 2: Objective sensory (or motor) loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADL)
* Grade 3: Sensory (or motor) loss or paresthesia interfering with ADL
* Grade 4: Permanent sensory (or motor) loss that interferes with function
* Patient must be capable of understanding the investigational nature, potential risks and benefits of the study
* Patient must have adequate cardiac function; patient must not have:
* History of a myocardial infarction within 6 months of enrollment
* New York Heart Association (NYHA) class III or IV heart failure
* Uncontrolled angina or electrocardiographic evidence of acute ischemia
* Severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of active conduction system abnormalities
* Cardiac amyloidosis
* Patient must not have any other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
* Patient must not have poorly controlled hypertension
* Women must not be pregnant or breast feeding; all females of childbearing potential must have a blood test or urine study within 7 days prior to registration to rule out pregnancy
* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
|
NCT_ID
NCT00075881
|
Study_NameBortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma
| 14,555 |
Study Objectives
The purpose of this study is to collect beginning information on whether intravenous (IV) administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients with cancer.
Conditions: Neuropathic Pain
Intervention / Treatment:
DRUG: KRN5500, DRUG: Placebo
Location: United States, Puerto Rico
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* >= 18 years
* Diagnosis of advanced or recurrent cancer
* No options for curative chemotherapy, but palliative chemotherapy allowed under certain conditions
* Refractory neuropathic pain rated 4 or greater on 0 <= age <= 10 scale and failure to respond to 2 commonly used treatments
* If taking opioids for pain, stable regimen over past week before enrolling
* Karnofsky performance status of 40 or more
* Females must be sterile or post-menopausal
Exclusion Criteria:
* Radiation to site of neuropathic pain for past 4 weeks
* Major surgery within past 2 weeks
* Liver function and other key labs outside normal parameters
* ECG showing significant abnormality
* Myocardial Infarction (heart attack) within past 6 months
* History of interstitial lung disease
* History of severe allergic reaction to drugs containing polysorbate 80
* Other investigational drug within 2 weeks or 5 half-lives (whichever is longer
|
NCT_ID
NCT00474916
|
Study_NameNeuropathic Pain in Patients With Cancer
| 4,737 |
Study Objectives
The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.
Conditions: Colorectal Neoplasms
Intervention / Treatment:
DRUG: cefmetazole, DRUG: kanamycin/metronidazole
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection
Exclusion Criteria:
* ECOG Performance Status >=2
* Age<20
* Any organ dysfunction
* Ileus
* Preoperative infectious disease
* Antibiotic administration before surgery
* Steroid administration before surgery
* Neo-adjuvant radiation and/or chemo therapy
* Severe diabetes mellitus
* Pregnancy/lactational woman
* Severe allergy
|
NCT_ID
NCT00508690
|
Study_NameTrial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
| 17,082 |
Study Objectives
This study is being conducted to test study drug AZD1480 to see how it may work to treat myeloproliferative diseases. The main purpose of this study is to determine the safety and tolerability of AZD1480. This is the first time the drug has been given to humans and is classed as a first time in man study. Its main purpose is to establish a safe dosage of the drug and provide additional information on any potential side effects this drug may cause. The study will also assess the blood levels and action of AZD1480 in the body over a period of time and will indicate whether the drug has a therapeutic effect on myeloproliferative diseases.
Conditions: Primary Myelofibrosis (PMF), Post-Polycythaemia Vera, Essential Thrombocythaemia Myelofibrosis
Intervention / Treatment:
DRUG: AZD1480
Location: France, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: OTHER
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with myelofibrosis requiring therapy
* Evidence of post-menopausal status or sterile
* ECOG Performance Status <=2
Exclusion Criteria:
* Prior therapy with any JAK2 medications
* Significant lung disorder or lung disease
* Previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 28 days before study screening
* Eye disease of the cornea
* Patients requiring oxygen supplementation
* Ejection fraction <45% (ECHO/MUGA) or significant pulmonary hypertension >40 mm Hg (by Echo/Doppler)
* Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) <70% predicted or >130% predicted
* Diffusing capacity of the Lung for Carbon Monoxide (DLCO) corrected for hemoglobin <60% predicted, oxygen saturation <88% at rest or after a 6-minute flat walk, without supplemental oxygen
* Chest infection requiring antibiotics within 7 days of the first dose of Investigational product.
|
NCT_ID
NCT00910728
|
Study_NameStudy to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases
| 20,080 |
Study Objectives
This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.
Conditions: Recurrent Squamous Cell Lung Carcinoma, Stage IV Squamous Cell Lung Carcinoma AJCC v7
Intervention / Treatment:
BIOLOGICAL: Durvalumab, OTHER: Laboratory Biomarker Analysis, BIOLOGICAL: Tremelimumab
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 been assigned to S1400F
* Patients must have progressed during or after prior platinum-based chemotherapy; patients whose only prior platinum-based chemotherapy regimen was for stage I-III disease (i.e. patient has not received any platinum-based chemotherapy for stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy; patients must have experienced disease progression during or after prior anti-PD-1 or anti-PD-L1 antibody monotherapy as their most recent line of treatment; prior PD-1/PD-L1 combination therapy is not permitted
* Prior exposure to CTLA-4 inhibitors (ipilimumab and tremelimumab) is not permitted; prior exposure to the following is allowed: attenuated vaccines, anti-EGFR agents, and granulocyte-macrophage colony-stimulating factor (GM-CSF)
* Patients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registration
* Patients must not have any prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, immune-mediated alopecia, Grave?s disease, or psoriasis requiring systemic treatment within the past 2 years are not eligible; patients with hypothyroidism (e.g. post Hashimoto syndrome) who are stable on hormone replacement therapy are eligible
* Patients must not have any history of primary immunodeficiency
* Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive these medications while on protocol therapy; systemic corticosteroids must be stopped at least 24 hours prior to sub-study registration; however, intranasal and inhaled corticosteroids are allowed at any time before and during protocol therapy
* Patients must not have experienced a grade 3 or worse immune-related adverse event (irAE) (except asymptomatic nonbullous/nonexfoliative rash) or any unresolved irAE grade 2, nor have experienced a toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
* Patients must not have any history of organ transplant that requires use of immunosuppressives
* Patients must not have any known allergy or reaction to any component of the durvalumab (MEDI4736) and/or tremelimumab formulation
* Patients must not have clinical signs or symptoms of active tuberculosis infection
* Patients must not have received a live attenuated vaccination within 28 days prior to sub-study registration
* Patients must not have known human immunodeficiency virus (HIV), or a known positive test for hepatitis B virus surface antigen (HBV sAg), or hepatitis C virus ribonucleic acid (HCV antibody) indicating current acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed
* Patients must have a thyroid-stimulating hormone (TSH) with reflex free T3/free T4 (if TSH is out of normal range) and electrocardiogram (EKG) obtained within 7 days prior to sub-study registration
* Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens
|
NCT_ID
NCT03373760
|
Study_NameDurvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer
| 1,636 |
Study Objectives
Milk thistle is an herbal drug that may have some liver protection properties and may reduce inflammation in the liver. It may also have anticancer effects. However milk thistle is not approved by the Food and Drug Administration for any medical purpose in the United States.
It has not been used in patients with liver cancer previously, to our knowledge, but there have been many studies of its use in patients with hepatitis and cirrhosis. Some of these studies have shown that milk thistle may help reduce elevated liver function tests.
Siliphos is a derivative of milk thistle that can be absorbed better than some other types of milk thistle. The investigators would like to perform a study to identify doses of siliphos that are safe to take in advanced liver cancer and to identify positive or negative side effects this compound may have. The investigators will be using this information in future studies to see if siliphos can be used as a therapy in patients with advanced liver cancer to reduce elevated liver function tests.
Conditions: Advanced Hepatocellular Carcinoma
Intervention / Treatment:
DRUG: Silybin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age >=18 years
* ECOG performance score of 0 <= age <= 3
* Expected survival of >12 weeks
* Subjects with advanced HCC or locally advanced, unresectable HCC
* Elevated LFTs (including at least one of the following: TBili >1.5 times the upper limit of normal; serum AST >2.5 times the upper limit of normal
* HCC diagnosed/defined based on either biopsy, or by suggestive radiologic imaging according to the AASLD guidelines (arterial enhancement with venous washout) or an AFP >200 ng/ml
* Subjects must have measurable disease that can be accurately measured in at least one dimension (with at least >20mm diameter in the longest dimension by conventional imaging or >10 mm by helical CT)
* Elevated liver enzymes that are either due to underlying liver disease and/or tumor which is not amenable to stenting after discussion with interventional GI and/or IR
* Subjects must demonstrate an ability to understand the consent process and willingness to sign a written informed consent form
* Subjects must agree to use birth control pills or other active contraception during active study treatment
Exclusion Criteria:
* Pregnant women or women currently breastfeeding will be excluded from this study because the effects of silybin on pregnant women and/or nursing infants are not known
* Subjects must have < grade 4 hepatic toxicity
* Known brain metastases because of poor prognosis and as patients with brain metastases often develop neurological dysfunction that may confound evaluation of neurologic and other adverse side effects
* History of allergic reactions to the study medication
* Uncontrolled concurrent illness including, but not limited to: ongoing active infection (including SBP), symptomatic congestive heart failure, unstable angina, active cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
|
NCT_ID
NCT01129570
|
Study_NameSiliphos in Advanced Hepatocellular Carcinoma
| 11,649 |
Study Objectives
An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma
Conditions: Relapsed/Refractory Multiple Myeloma
Intervention / Treatment:
DRUG: IBI346
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
* Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD).
* Measurable disease as defined by the protocol
* ECOG score is 0 or 1.
* Expected survival time >=12 weeks.
Exclusion Criteria:
* Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs.
* Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
* No unmobilized mononuclear cells can be collected for CAR T cell production.
* Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses < 10mg/ day).
* Patients with a history of hypertension that cannot be controlled by medication (blood pressure >=140/90 mmHg).
|
NCT_ID
NCT05270928
|
Study_NameStudy to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#
| 19,965 |
Study Objectives
The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.
Conditions: Colorectal Cancer Metastatic
Intervention / Treatment:
DRUG: Cetuximab
Location: Israel
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Age above 18 years.
* Histology or cytology proven KRAS-WT mCRC.
* Performance status <=3 (Eastern Cooperative Oncology Group [ECOG] classification)
* Life expectancy of more than 12 weeks.
* Written informed consent.
* In women of childbearing potential, appropriate contraceptive measures must be used during treatment with cetuximab and for 6 months following the last dose of cetuximab.
Exclusion Criteria:
* Past systemic immune therapy for disease other than cancer.
* Past immune or other target therapy for cancer (not including bevacizumab).
* Presence of acne or acneiform rash prior to starting treatment with cetuximab.
* Patients with treatment plan of cetuximab and capecitabine combination.
* For female patients: the patient is pregnant or lactating.
|
NCT_ID
NCT01382407
|
Study_NameDoes Acne Rash During Adolescence Predict Skin Reaction to Cetuximab
| 17,675 |
Study Objectives
This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738.
Conditions: Advanced Nonhaematologic Malignancies
Intervention / Treatment:
DRUG: BOS172738
Location: United States, Spain, Taiwan, Belgium, France, Korea, Republic of, Hong Kong
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
* Male or female participants must be >= 18 years, at the time of signing the informed consent
* Diagnosis of advanced solid tumor with a documented rearranged during transfection (RET) gene altered malignancy as determined locally by a DNA based assay of tumor tissue and/or blood
* Participants must have no alternative approved therapy.
* For participants in Part B expansion cohort only: documented local diagnosis of either 1) advanced RET gene fusion non-small cell lung cancer (NSCLC); 2) advanced RET gene mutant medullary thyroid cancer (MTC); or 3) other RET gene altered advanced tumors or NSCLC/MTC with prior specific RET gene targeted therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Negative pregnancy test for females of child bearing potential; must be surgically sterile, postmenopausal, or willing and able to be compliant with a contraceptive regimen
* Contraceptive use by men or women should be consistent with local regulations.
* Capable of giving signed informed consent
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Inability to take oral medications or gastrointestinal (GI) conditions that can interfere with the swallowing or absorption of study medication
* Uncontrolled or severe concurrent medical condition
* History of upper GI bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug
* Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug
* Participants with known infection with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) (testing not required)
* Participants who are hepatitis B surface antigen positive or participants who are hepatitis C antibody positive (Participants who have been successfully treated for hepatitis C virus [HCV] are eligible if an undetectable HCV viral load at least 6 months after completion of treatment can be demonstrated.)
* Any evidence of serious active infections
* Uncontrolled or severe cardiovascular disease
* Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
* Participants with a prior or concurrent malignancy other than the malignancies under study
* Ongoing cancer directed therapy
|
NCT_ID
NCT03780517
|
Study_NameSafety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors
| 6,585 |
Study Objectives
To characterize the safety profile of ARGX-110 administered as mono- or combination therapy to patients with NPC at various stages of its natural history (adjuvant vs. metastatic).
Conditions: Cancer
Intervention / Treatment:
DRUG: ARGX-110
Location: Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion criteria:
* Age >=18 years.
* Written informed consent prior to any study-related procedure
* Willing and able to comply with protocol-specified procedures and scheduled evaluations
* Pathological diagnosis of nasopharyngeal carcinoma (NPC)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1or 2
* Absolute neutrophil count (ANC) > 0.5 x 109/L
* Haemoglobin > 80 g/L
* Platelet count >= 50 x 109/L
* Total bilirubin <= 2 x the upper limit of normal (ULN)
* Alanine transaminase (ALT) <= 5 x ULN
* Serum creatinine <= 2 x ULN
Exclusion criteria:
* History or clinical evidence of neoplastic central nervous system (CNS) involvement. Note: Irradiated brain metastases that have been stable for > 1 month and do not require systemic glucocorticoid administration are allowed
* Major surgery within 4 weeks of ARGX-110 first dose administration
* Unresolved grade 3 or 4 toxicity from prior therapy (except mucositis from local radiation therapy).
* Active, untreated viral, bacterial, or systemic fungal infection
* Childbearing potential unless using an adequate measure of contraception
* Pregnancy or lactation. History of hypersensitivity to recombinant proteins
* Any clinical finding, including psychiatric and behavioural problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study
|
NCT_ID
NCT02759250
|
Study_NameA Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
| 13,808 |
Study Objectives
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.
Conditions: Actinic Keratosis
Intervention / Treatment:
DRUG: Fluorouracil 0.5%
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Any male or female 50 years or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation.
Exclusion Criteria:
* Age less than 50.
* Known allergy or sensitivity to topical Carac® in the subject.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study.
* Subjects should not receive surgical or cryotherapy while participating in the study.
* Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control
|
NCT_ID
NCT00696488
|
Study_NameMeasuring Adherence To Topical 5-Fluorouracil in a Clinic Population
| 18,237 |
Study Objectives
Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.
Conditions: Melanoma
Intervention / Treatment:
DRUG: Talimogene laherparepvec, DRUG: Ipilimumab
Location: France, Germany, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed diagnosis of malignant melanoma.
* Stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c disease that is not suitable for surgical resection
* Phase1: Treatment naïve: Must not have received any prior systemic anticancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy for unresected stage IIIB to IV melanoma.
* Phase 2:
* Either treatment naïve or received only one line of systemic anticancer therapy if v-raf murine sarcoma viral oncogene homolog B1 (BRAF) wild-type or up to two lines of systemic anticancer therapy including one BRAF inhibitor-containing regimen if BRAF mutant. Treatments given in an adjuvant setting (eg, interferon, radiotherapy, isolated limb perfusion, or investigational agents) are not considered as prior lines of therapy. No prior talimogene laherparepvec, other oncolytic virus therapies, or tumor vaccines are allowed, even if given in the adjuvant setting.
* Subjects treated with prior ipilimumab must have had partial response (PR), complete response (CR), or at least 6 months of stable disease followed by disease progression.
* Subjects previously treated with anti-program death-1 (PD1) or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) antibodies must not have discontinued therapy due to any treatment-related adverse events including immune-related adverse events. Prior treatment-related adverse events should also be fully resolved and not requiring treatment for at least 28 days prior to randomization.
* Measurable disease defined as one or both of the following
* at least 1 melanoma lesion that can be accurately and serially measured in at least 2 dimensions and for which the longest diameter is >= 10 mm and with perpendicular diameter >= 5 mm as measured by contrast-enhanced or spiral computed tomography (CT) scan for visceral or nodal/soft tissue disease. Lymph nodes must measure > 15 mm in their short axis to be considered measurable by CT scan.
* at least 1 superficial cutaneous or subcutaneous melanoma lesion that can be accurately and serially measured in at least 2 dimensions and for which the short axis is >= 5 mm as measured by calipers
* Injectable disease (ie, suitable for direct injection or through the use of ultrasound [US] guidance) defined as follows:
* at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion >= 5 mm in longest diameter
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematologic, hepatic, renal, and coagulation functions
Exclusion Criteria:
* Primary uveal or mucosal melanoma
* History or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia)
* Phase 1b: History or evidence of central nervous system (CNS) metastases
* Phase 2: Clinically active cerebral melanoma metastases. Subjects with up to 3 cerebral metastases, and neurological performance status of 0 may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, or Gamma knife therapy, with no evidence of progression, and have not required steroids, for at least 2 months prior to enrollment.
* History or evidence of symptomatic autoimmune disease (such as pneumonitis, glomerulonephritis, vasculitis, rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, scleroderma, or other), or history of autoimmune disease that required systemic treatment (ie, use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 months prior to enrollment. Replacement therapy (eg, thyroxine for hypothyroidism, insulin for diabetes mellitus) is not considered a form of systemic treatment for autoimmune disease.
* History of or plan for splenectomy or splenic irradiation
* Active herpetic skin lesions or prior complications of herpes simplex type-1 virus (HSV-1) infection (eg, herpetic keratitis or encephalitis).
* Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
* Known human immunodeficiency virus (HIV) disease
* Known acute or chronic hepatitis B or hepatitis C infection
* Phase 1b: Prior talimogene laherparepvec, ipilimumab, other CTLA-4 inhibitors, PD-1 inhibitors, or tumor vaccine
* Phase 2: Prior talimogene laherparepvec, other oncolytic virus therapies, or tumor vaccines
* Currently receiving or less than 28 days since ending systemic anticancer treatment for unresected stage IIIB to IV melanoma
|
NCT_ID
NCT01740297
|
Study_NameIpilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma
| 21,616 |
Study Objectives
This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.
Conditions: Gastrointestinal Stromal Tumors
Intervention / Treatment:
DRUG: AMN107, STI571
Location: France, Germany, United States, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with gastrointestinal stromal tumor (GIST).
* Patients who have had disease progression during imatinib therapy with 800 mg.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients with prior or concomitant malignancies other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ.
* A history of impaired cardiac function or uncontrolled cardiovascular disease.
* Severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107.
* Currently taking certain medications that could affect an electrocardiogram result.
* Women who are pregnant or breast feeding.
* Patients unwilling or unable to comply with the protocol.
NOTE: Additional inclusion and/ or exclusion criteria may apply.
|
NCT_ID
NCT00135005
|
Study_NameStudy of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
| 20,147 |
Study Objectives
The goal of this clinical research study is find the highest safe dose of cisplatin that can be given with liposomal doxorubicin in the treatment of advanced cancer involving the liver.
PRIMARY Objectives:
To determine the toxicity and safety of a monthly cytotoxic regimen combining intraarterial hepatic (HAI) cisplatin with systemic intravenous liposomal doxorubicin in patients with cancer metastatic to the liver.
SECONDARY Objectives:
To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial cisplatin in combination with systemic liposomal doxorubicin.
Conditions: Advanced Cancer
Intervention / Treatment:
DRUG: Cisplatin, DRUG: Liposomal Doxorubicin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with Histologically confirmed diagnosis of malignancy and liver involvement as dominant site of metastasis (over 50% of all tumor burden).
* Pediatric patients eligible at the discretion of the primary investigator.
* Performance Status Equivalent or Grater than 60% in the Karnofsky's Performance scale (Requires occasional assistance but is able to care for own needs).
* Adequate Renal Function (Serum CRE <= 1.5 mg/dL) or calculated Creatinine Clearance >= 50 ml/min (Cockcroft Formula).
* Adequate Hepatic Function (Total Bilirubin <= 1.5 mg/dL or ALT <= 5 times upper normal reference value).
* Adequate Bone Marrow Function (Absolute neutrophil count (ANC) >= 1.5 cells/uL; number of platelets (PLT) >= 100,000 cells/uL).
* At least three weeks from previous cytotoxic chemotherapy before day 1 of HAI infusion. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter.
* All Females in Childbearing Age MUST have a negative urine or serum Human chorionic gonadotropin or human chorionic gonadotrophin (hCG) test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity).
* Ability to fully read, comprehend, and sign informed consent forms. In pediatric patients, the informed consent forms will be signed by a parent or legal guardian.
* Patients with germ cell tumors and lymphoma MUST have had documented progression of disease prior to enrollment.
Exclusion Criteria:
* Clinical or radiographic evidence of Ascites.
* Pregnant females.
* Hypersensitivity to platinum compounds or anthracyclines.
* Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
* Jaundice. (Bilirubin > 1.5 mg/dL).
* Bleeding Diathesis.(Prothrombin time > 20 secs or International Normalized Ratio (INR) > 2.0).
* Portal vein thrombosis.
* Grade 2 Peripheral Neuropathy (CTC V3.0: Sensory alteration interfering with function but not interfering with ADL)
* Medical History or Clinical Evidence of Congestive Heart Failure.
|
NCT_ID
NCT00507962
|
Study_NameCisplatin HAI Study in Patients With Advanced Cancer and Dominant Liver Involvement
| 3,304 |
Study Objectives
This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, plus the addition of Rituximab (which is a form of immunotherapy).
Conditions: Lymphoma, Non-Hodgkin's
Intervention / Treatment:
DRUG: Rituximab
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 documented, aggressive and/ or intermediate grade and high-grade B cell NHL, CD20 positive.
* In relapse after primary conventional chemotherapy
* Tumor sensitive (at least a partial response) to induction chemotherapy and/ or radiation therapy after treatment for relapse
* Treatment of CNS or meningeal disease (cytology-negative CSF) if present
* Treatment of CNS or meningeal disease (cytology-negative CSF) if present.
* Cumulative total doxorubicin dosage <500 mg/m2
* Performance score: 0 <= age <= 2
* Prior malignancies eligible if treated for cure and without active disease
* Patients must not be pregnant or nursing.
* Prior Immunotherapy is allowed
* Signed Informed Consent
* Absolute neutrophil count > 1500/ µl, platelet count >100,000/ µl
* Bilirubin <1.5 x normal, SGOT <2.5 x normal
* Serum creatinine <1.5 mg/dl
* Ejection fraction > 45% or > 40% with normal wall motion
* HIV negative
* FEV1, DLCO > 50% predicted
Exclusion Criteria:
* Pregnant or nursing
|
NCT_ID
NCT00143871
|
Study_NameStudy of Rituximab Plus High-Dose Chemotherapy Non-Hodgkin's Lymphoma
| 17,879 |
Study Objectives
This is a 2-phase retrospective database study, using both case-cohort and inception (intention-to-treat) cohort analyses to evaluate any association between oral treatments for osteoporosis and the risk of esophageal cancer in women.
Conditions: Esophageal Cancer, Squamous Cell Carcinoma, Adenocarcinoma
Intervention / Treatment:
DRUG: Alendronate, DRUG: Etidronate, DRUG: Ibandronate, DRUG: Risedronate, DRUG: Raloxifene
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Cases:
* Women in the database aged >= 55 years between 1996 and 2008 with diagnosis of esophageal cancer
* Comparator Controls:
* Each case was matched to all women in the random subcohort of 25,000 who had the same year of birth as the case and were in the database at the time of diagnosis.
Exclusion Criteria:
* Women with diagnosis of any other cancer or Paget's Disease or who have received oral or intravenous steroids before the index date
|
NCT_ID
NCT01077817
|
Study_NameObservational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)
| 7,994 |
Study Objectives
This pilot Phase II study is designed to evaluate the efficacy and tolerability of crenolanib in two cohorts of AML patients with FLT3 activation mutations (patients whose leukemia has recurred after prior chemotherapy not including a FLT3 TKI and patients whose leukemia has progressed after prior therapy with a FLT3 TKI).
Conditions: Acute Myeloid Leukemia With FLT3 Activating Mutations That Has Relapsed or Been Refractory After One or More Prior Therapies
Intervention / Treatment:
DRUG: Crenolanib besylate
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:
* Confirmed primary AML relapsed or refractory after prior therapy, AML secondary to antecedent chemotherapy or radiation therapy, or AML due to prior myelodysplastic syndrome (MDS)/ myeloproliferative neoplasm (MPN) as defined by WHO criteria with presence of either FLT3 ITD and/or other FLT3 activating mutations
* Patients with secondary AML should have failed no more than two (2) prior regimens
* Patients with antecedent MDS/MPN, defined by WHO criteria, without any prior therapy for AML, regardless of the number of therapies for MDS/ MPN
* Patients with primary AML should have received no more than two (2) prior cytotoxic containing salvage regimens. Reinduction with the same regimen or stem cell transplant will not be considered a separate salvage regimen. Change of drugs will be considered a salvage regimen. Unlimited FLT3 TKI therapy (even in combination with cytotoxics/hypomethylating agents) is allowed for patients enrolled in cohort B
* Patients must have tested positive for FLT3-ITD and /or other FLT3 activating mutations within 30 day screening period
* Males and females age >=18 years
* ECOG PS 0 <= age <= 2
* Adequate liver function, defined as bilirubin <=1.5x ULN, ALT <=3.0x ULN, and AST <=3.0x ULN
* Adequate renal function, defined as serum creatinine <=1.5x ULN
* Recovery from non-hematological toxicities of prior therapy (including HSCT) to no more than grade 1 (except alopecia)
* Subjects should have received no anti-leukemic therapy (except hydroxyurea) prior to the first dose of crenolanib as follows: for 14 days for classical cytotoxic agents and for five times the t1/2 (half-life) for FLT3 inhibitors and antineoplastic agents that are neither cytotoxic nor FLT3 inhibitors (e.g. hypomethylating agent or MEK inhibitor)
* Negative pregnancy test for WOCBP
* Able and willing to provide written informed consent.
Exclusion Criteria:
* Absence of a FLT3 activating mutation
* <5% blasts in blood or marrow at screening
* Concurrent chemotherapy, or targeted anti-cancer agents, other than hydroxyurea
* Patient with concurrent severe and/or uncontrolled medical conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
* HIV infection or active hepatitis B (defined as hepatitis B surface antigen positive) or C (defined as hepatitis C antibody positive)
* Known clinically active central nervous system (CNS) leukemia
* Patients less than 30 days post HSCT
* Subjects who have clinically significant graft versus host disease requiring treatment and /or have >grade 2 persistent non hematological toxicity related to transplant
* Prior crenolanib treatment for a non-leukemic indication
* Major surgical procedures within 14 days of Day 1 administration of crenolanib.
* Unwillingness or inability to comply with protocol.
|
NCT_ID
NCT01657682
|
Study_NameA Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
| 1,998 |
Study Objectives
The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that works by preventing cells in the body from growing and dividing. Information from basic and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor growth in people with relapsed or refractory lymphoma.
Conditions: Waldenstrom's Macroglobulinemia
Intervention / Treatment:
DRUG: RAD001
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:
* 18 years or older
* Adequate liver and renal function as outlined in the protocol
* Fasting serum cholesterol 300mg/dl or less OR 7.75mmol/L or less AND fasting triglycerides 2.5 x institutional ULN or less.
* Clinicopathological diagnosis of Waldenstrom's macroglobulinemia as defined by consensus panel of the Second International Workshop on Waldenstrom's macroglobulinemia
* No previous therapy for WM
* Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of 2 times the upper limit of each institution's normal value or greater is required
* ECOG Performance status of 0 <= age <= 2
* Patients must have a life expectancy of at least 3 months
* Baseline platelet and absolute neutrophil as outlined in the protocol
* INR and PTT 1.5 x normalized ratio or less
* A male subject agrees to use an acceptable method for contraception for the duration of study and for 8 weeks after the last dose of the study drug
* Female subject either post-menopausal or surgically sterilized or willing to use acceptable methods of birth control for the duration of the study and for 8 weeks after the last dose of study drug
Exclusion Criteria:
* Patients experiencing symptomatic hyperviscosity and requiring plasmapheresis. This includes any patient who, in the judgement of the investigator requires urgent response and will not be eligible. These patients have hyperviscosity which includes serum IgM levels of 5000 mg/dL or greater. Symptoms may include nosebleeds, visual complications, fatigue, headaches, confusion, etc.
* Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study.
* Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
* Patients should not receive any immunization with attenuated live vaccines within one week of study entry or during study period.
* Patients who have had any severe and/or uncontrolled medical conditions or other conditions that would affect their participation in the study.
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001.
* Female patients that are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
* Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients
* Patients with other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell of the skin
* Patients with known history of HIV seropositivity
* History of noncompliance to medical regimens
* Patients unwilling to or unable to comply with the protocol
|
NCT_ID
NCT00976248
|
Study_NameEverolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia
| 663 |
Study Objectives
This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen is inactive. In addition, it will assess toxicity of this drug in patients with WM. Patients will receive perifosine 150 mg qhs daily. Patients will be assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks.
Conditions: Waldenström's Macroglobulinemia
Intervention / Treatment:
DRUG: Perifosine
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:
* Age >= 18 years.
* Must have received prior therapy for their WM and have relapsed or refractory WM. Any number of prior therapies is acceptable.
* Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of > 2 times the upper limit of each institution's normal value is required and over 10% of lymphoplasmacytic cells in the bone marrow.
* ECOG Performance Status (PS) 0, 1, or 2.
* The following laboratory values obtained 14 days prior to registration
* ANC >= 1 x109/L
* PLT >= 75 x109/L
* Total bilirubin <= 2.0 mg/dL (If total is elevated check direct and if normal patient is eligible.)
* AST <= 3 x upper limit of normal (ULN)
* Creatinine <= 2 x ULN
* Ability to provide informed consent.
* Life expectancy >= 12 weeks.
Exclusion Criteria:
* Uncontrolled infection.
* Other active malignancies.
* CNS involvement.
* Cytotoxic chemotherapy <= 3 weeks, or biologic therapy <= 2 weeks, or corticosteroids <= 2 weeks, prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than WM such as auto-immune diseases. Plasmapheresis is not considered as an active therapy and can be used at the physician's discretion.
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational.
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device (IUD), or abstinence, etc.)
* Known to be HIV positive.
* Radiation therapy <= 2 weeks prior to registration.
|
NCT_ID
NCT00398710
|
Study_NameA Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
| 13,545 |
Study Objectives
This randomized phase II trial studies temozolomide, radiation therapy, and cediranib maleate to see how well they work compared with temozolomide, radiation therapy, and a placebo in treating patients with newly diagnosed glioblastoma (a type of brain tumor). Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether temozolomide and radiation therapy are more effective when given with or without cediranib maleate in treating glioblastoma.
Conditions: Adult Glioblastoma, Adult Gliosarcoma
Intervention / Treatment:
RADIATION: 3-Dimensional Conformal Radiation Therapy, DRUG: Cediranib Maleate, RADIATION: Intensity-Modulated Radiation Therapy, OTHER: Laboratory Biomarker Analysis, OTHER: Placebo Administration, DRUG: Temozolomide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Histologically proven diagnosis of glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV) confirmed by central review prior to step 2 registration
* Tumor tissue that is determined by central pathology review prior to step 2 registration to be of sufficient size for analysis of MGMT status
* Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged
* Cavitron ultrasonic aspirator (CUSA)-derived material is not allowed; fresh frozen tumor tissue acquisition is encouraged
* Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy is not allowed because it will not provide sufficient tissue for MGMT analysis
* The tumor tissue must be sent as soon as possible to maximize the likelihood of eligibility; tumor tissue may not be submitted later than 28 days after the surgical procedure, because tissue analysis will not be able to be performed in time for treatment to commence by the mandatory 6-week post-surgery outer limit; submission of tissue earlier than 28 days post-surgery is highly recommended
* The tumor must have a supratentorial component
* History/physical examination, including neurologic examination, within 14 days prior to step 2 registration
* The patient must have recovered from the effects of surgery, post-operative infection, and other complications before step 2 registration
* A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed preoperatively and postoperatively prior to step 1 registration; the postoperative scan must be performed within 28 days prior to step 1 registration
* Documentation of steroid doses/concurrent medications within 14 days prior to step 2 registration
* Karnofsky performance status >= 70 within 14 days prior to step 2 registration
* Complete blood count (CBC)/differential obtained within 14 days prior to step 2 registration on study, with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
* Platelets >= 100,000 cells/mm^3
* Hemoglobin >=10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)
* Adequate renal function, as defined below:
* Blood urea nitrogen (BUN) =< 30 mg/dl within 14 days prior to step 2 registration
* Creatinine =< 1.7 mg/dl within 14 days prior to step 2 registration
* Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x normal range within 14 days prior to step 2 registration
* Systolic blood pressure =< 140 mm Hg AND diastolic pressure =< 90 mm Hg within 14 days prior to step 2 registration in the presence or absence of a stable regimen of anti-hypertensive therapy
* Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing within 1 week of step 2 registration
* Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:
* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
* In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
* Patient must provide study specific informed consent prior to step 1 registration
* Women of childbearing potential and male participants must practice adequate contraception
* For females of child-bearing potential, negative serum pregnancy test within 14 days prior to step 2 registration
Exclusion Criteria:
* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years; (for example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible)
* Recurrent or multifocal malignant gliomas
* Metastases detected below the tentorium or beyond the cranial vault
* Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide or cediranib); prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
* Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
* Severe, active co-morbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization
* Transmural myocardial infarction within the last 6 months
* Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 14 days of step 2 registration
* New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
* History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months
* Serious and inadequately controlled cardiac arrhythmia
* Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for tumor resection
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
* Active connective tissue disorders, such as lupus or scleroderma, which in the opinion of the treating physician may put the patient at high risk for radiation toxicity
* Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
* Pregnant or lactating women
* Prior allergic reaction to temozolomide
* Patients treated on any other therapeutic clinical protocols within 30 days prior to step 1 registration or during participation in the study
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib
* Mean QTc >500 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome or other significant ECG abnormality noted within 14 days of treatment
* Patients receiving concurrent vascular endothelial growth factor (VEGF) inhibitors are prohibited from participating in this study
* Patients must not be on enzyme-inducing anti-epileptic drugs (EIAED); patients may be on non-enzyme inducing anti-epileptic drugs (NEIAED) or may not be taking any anti-epileptic drugs; in patients who have previously been on EIAED there must be at least a 14 day period since the last dose of an EIAED before the first dose of cediranib
|
NCT_ID
NCT01062425
|
Study_NameTemozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma
| 3,748 |
Study Objectives
The purpose of this study is to compare progression free survival for SU011248 \[sutent (sunitinib malate)\] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.
Conditions: Breast Neoplasms
Intervention / Treatment:
DRUG: SU011248, DRUG: Chemotherapy
Location: Ukraine, Germany, United States, Spain, Czech Republic, United Kingdom, Italy, Bulgaria, Canada, Turkey, France, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Recurrent or metastatic breast cancer
* Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status
* Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting
* Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease
Exclusion Criteria:
* More than two chemotherapy regimens for advanced disease
* Uncontrolled/symptomatic spread of cancer to the brain
|
NCT_ID
NCT00246571
|
Study_NameStudy Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer
| 20,797 |
Study Objectives
The purpose of this study is to determine if the combination of bevacizumab and pemetrexed have an effect on recurrent ovarian and primary peritoneal carcinoma by looking at progression and survival at 6 months.
Conditions: Ovarian Carcinoma, Primary Peritoneal Carcinoma
Intervention / Treatment:
DRUG: Pemetrexed, DRUG: Bevacizumab
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:
* Recurrent epithelial ovarian or primary peritoneal carcinoma. Histologic confirmation of the primary tumor is required. Patients with borderline tumors are not eligible.
* Patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in one dimension (longest dimension to be recorded). Each lesion must by > 20 mm when measured by conventional imaging techniques, including plain radiography, computed tomography and MRI or > 10 mm when measured by spiral CT.
* Patients must have at least one "target lesion" to assess response by RECIST criteria. Lesions within a previously irradiated field will be considered "non-target" lesions.
* Patients must have a GOG performance status of 0 or 1.
* Patients must have the ability to interrupt non-steroidal anti-inflammatory (NSAID) treatment 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
* Patients must have the ability to take folic acid, vitamin B12 and dexamethasone as described per protocol.
* Recovery from effects of recent surgery, radiotherapy or chemotherapy.
* Patients should be free of active infection requiring antibiotics.
* Any hormonal therapy directed at the tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy (HRT) is permitted.
* Any other prior therapy directed at the malignant tumor, including immunologic agents and cytotoxic agents, must be discontinued at least three weeks prior to registration.
* 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 high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment.
* Patients must have had one prior regimen containing a taxane compound. Patient may have received first-line treatment either intravenously or intraperitoneally.
* Patients must NOT have received prior therapy with pemetrexed or bevacizumab.
* Patients may have received a total of < 2 prior cytotoxic chemotherapy regimens (adjuvant therapy plus one additional regimen). Consolidation or extended therapy as part of first line treatment will be considered as a single regimen.
* Bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (CTC) grade 1; Platelets greater than or equal to 100,000/ul.
* Creatinine clearance must be greater than 45 ml/min.
* Hepatic function: bilirubin less than or equal to 1.5 x ULN. AST and alkaline phosphatase less than or equal to 2.5 x ULN.
* Neurologic function: neuropathy (sensory and motor) less than or equal to CTC grade 1.
* Coagulation: prothrombin time (PT) such that the international normalized ratio (INR) is < 1.5 (INR may be between 2 and 3 if a patient is on stable dose of therapeutic warfarin) and a PTT < 1.2 times control.
* Patients must have signed informed consent.
* Patients must meet pre-entry requirements.
* Patients of childbearing potential must have a negative serum pregnancy test prior to study entry, be practicing an effective form of contraception, and cannot be lactating.
* Patients may have received prior radiotherapy (to less than 25% of bone marrow), but must start at a Level 1 dose reduction.
Exclusion Criteria:
* Patients with serious, non-healing wound, ulcer or bone fracture.
* Patients with clinically significant cardiovascular disease:
* Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
* Any prior history of hypertensive crisis or hypertensive encephalopathy.
* Unstable angina within 6 months prior to study enrollment.
* New York Heart Association (NYHA) grade II or greater congestive heart failure.
* Serious cardiac arrhythmia requiring medication.
* Grade II or greater peripheral vascular disease. Patients with claudication within 6 months.
* History of myocardial infarction within 6 months.
* Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
* Patients with the presence of ascites or other third space fluid which cannot be controlled by drainage.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of study or anticipation of need for major surgical procedure during the course of the study.
* Patients with history or evidence upon physical examination of central nervous system disease, including primary brain tumor, brain metastases, seizure not controlled with standard medical therapy, history of cerebrovascular accident (CVA, stroke), or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
* Minor surgical procedures, other than central venous access placement, such as fine needle aspiration or core biopsy within 7 days prior to day 1 of study.
* Patients with proteinuria. At baseline patients will undergo a urine protein-creatinine ratio (UPCR) (Appendix IV). Patients with a UPCR > 1.0 at screening should be excluded. Urine dipstick for proteinuria may also be used. Urine dipstick for proteinuria >= 2+ (patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate <= 1g of protein in 24 hours to be eligible).
* Patients whose circumstances do not permit completion of the study or the required follow-up.
* Patients who are pregnant or nursing.
* Patients under the age of 18.
* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer within the last 5 years or whose previous cancer treatment contraindicates this protocol.
* Prior therapy with anti-angiogenic agents or pemetrexed.
* Patients with active infection requiring parenteral antibiotics.
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months.
* Partial or complete small or large bowel obstruction demonstrated radiographically within 3 months prior to study.
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
* Known hypersensitivity to any component of bevacizumab.
* Inability to comply with study and/or follow-up procedures.
* Life expectancy of less than 12 weeks.
|
NCT_ID
NCT00868192
|
Study_NameTrial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma
| 5,530 |
Study Objectives
The aim of this study is to evaluate the efficacy in terms of clinical and biological response rates of Imatinib Mesylate therapy in patients with systemic mastocytosis lacking KIT mutations.
Conditions: Systemic Mastocytosis
Intervention / Treatment:
DRUG: Imatinib Mesylate
Location: Spain
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age older than 18 years.
* Diagnosis of systemic mastocytosis in the absence of c-kit mutation.
* ECOG <= 3.
* Signed informed consent.
Exclusion Criteria:
* Previous therapy with a tyrosin kinase inhibitor.
* Positive antibodies against HIV or active viral hepatitis.
* Impaired liver function (total bilirubin >= 2.0 mg/dl, AST or ALT > 3 x upper limit of normal).
* Impaired renal function (>= 2.0 mg/dL).
* Grade III-IV cytopenias not related to mastocytosis.
* Severe cardiopathy (grade III/IV of NYHA, or left ventricular ejection fraction < 50%).
* Pregnancy or breastfeeding.
* Female patients who do not use contraceptive methods.
|
NCT_ID
NCT01297777
|
Study_NameImatinib in KIT-negative Systemic Mastocytosis
| 21,959 |
Study Objectives
Bevacizumab in combination with chemotherapy represents a standard of care for first-line treatment in patients with advanced colorectal cancer. Molecular predictive factors for bevacizumab efficacy have not yet been identified therefore selection of patients more likely to benefit from such a treatment approach is not possible. Retrospective analyses suggested that LDH serum levels may influence the clinical activity of anti-angiogenetic drugs. Primary aim of our clinical trial will be to prospectively ascertain whether bevacizumab in combination with chemotherapy has an improved clinical activity in patients with high LDH serum levels compared to patients with normal LDH serum levels
Conditions: Colorectal Cancer Stage II
Intervention / Treatment:
DRUG: Bevacizumab and FOLFIRI
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: SINGLE
|
Inclusion Criteria:
* Written informed consent
* No prior treatment for advanced disease (adjuvant therapy allowed)
* age < 75 years < 18 years
* Histologically/cytologically confirmed advanced, colorectal cancer
* At least one lesion measurable with CT or MRI scan
* Performance Status (ECOG) 0 <= age <= 1 at study entry)
* Life expectancy of at least 6 months
* Neutrophils count =/> 1.5 x 109/L, platelets count =/> 100 x 109/L, HGB =/> 10 g/dL
* total bilirubin < 1.5 x UNL
* SGOT and SGPT =/< 2.5 x UNL (=/< 5 x UNL in patients with liver metastases)
* Creatinine < 1.5 x UNL
Exclusion Criteria:
* CNS metastases
* Severe cardiovascular disease
* Uncontrolled infections
* Radiotherapy within 4 weeks of study entry
* Any experimental drug administered within 4 weeks of study entry
* Known hypersensitivity to study drug
* Known drugs or alcohol abuse
* Pregnant or lactating women (serum Betahcg test)
* Other tumours, except in situ melanoma or cervix cancer if radically removed
* Incapability to sign informed consent
|
NCT_ID
NCT01853813
|
Study_NameFirst-line Irinotecan, Lederfolin and 5FU (FOLFIRI) and Bevacizumab in Patients With Advanced Colorectal Cancer
| 7,526 |
Study Objectives
Cancer patients with COVID-19 have a 30% higher mortality rate compared to the general population and are considered a high-risk group by the American Association for Cancer Research that should be given "high priority" during COVID-19 vaccine administration. Although studies have suggested that vaccination during active treatment with chemo and/or radiation therapy provides suboptimal antibody response, the studies were underpowered and heterogeneous thus putting this conclusion into question. We need data in cancer patients on immunosuppressive chemotherapy at the time of COVID vaccination to understand how immune responses compare to healthy controls and cancer patients not on immunosuppressive therapy.
Conditions: Cancer; Chemotherapy
Intervention / Treatment:
OTHER: COVID antibody titers in the blood
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Participants must meet all of the following inclusion criteria to be eligible for enrollment:
1. Willing and able to provide written informed consent for the trial.
2. Male or female participants >18 years on the day of signing informed consent.
3. a. Participants (>18 years) with gastrointestinal (gastroesophageal, pancreatic, small bowel, colon, anal) solid tumors, breast, or prostate cancers who received myelosuppressive chemotherapy within 60 days prior to initial or booster COVID vaccination, or who started on chemotherapy within 60 days after the initial or booster COVID vaccination; or b. Adult participants (>18 years) not receiving chemotherapy at the time of initial or booster COVID vaccination, but who were on non-immunosuppressive treatments (endocrine therapy, treatment with tyrosine kinase inhibitor or antiHER-2 therapy); or c. Adult participants > 18 years either: (i) with no history of cancer or (ii) prior history of non-metastatic solid cancer invasive cancer treated with a curative intent, without evidence of disease recurrence, and >12 months from completion of chemotherapy or radiation.
4. a. Participants in groups A and B who have a planned COVID vaccination within the next 90 days of study enrollment with any FDA approved vaccine, or previous COVID vaccination within 90 days from study enrollment are eligible provided they meet all other above eligibility criteria; or b. Participants in group C who have planned COVID vaccination within the next 90 days of study enrollment with any FDA approved vaccine; or previous COVID vaccination within six months from study enrollment are eligible provided they meet all other above eligibility criteria
Exclusion Criteria:
* Participants will be considered ineligible for enrollment with the following criteria:
1. Participants currently on immunotherapy
2. Participants with documented COVID 19 infection within < 6 months from study enrollment
3. Prior history of autoimmune disorder and are currently on immunosuppressive therapy or have received immunosuppressive therapy within the last 6 <= age <= 12 months prior to enrollment
4. No planned and no prior COVID vaccination
|
NCT_ID
NCT05238467
|
Study_NameImmunological Responses of COVID-19 Vaccination
| 9,474 |
Study Objectives
This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.
Conditions: Brain Metastases
Intervention / Treatment:
DRUG: Gadobutrol (Gadavist, Gadovist, BAY86-4875), DRUG: Gadobutrol (Gadavist, Gadovist, BAY86-4875), DRUG: ProHance
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: DIAGNOSTIC
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: SINGLE
|
Inclusion Criteria:
* Japanese patients at least 20 years
* Patients with diagnosed primary cancer
* Patients with metastatic lesions by CT/MRI
Exclusion Criteria:
* Patients who have contraindication to the MRI examinations
* Patients who have severe renal disorder
* Patients in extremely serious general condition
|
NCT_ID
NCT00522951
|
Study_NameSH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
| 22,248 |
Study Objectives
This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) alone.
No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: Bevacizumab, DRUG: Capecitabine
Location: Slovenia, Poland, Spain, United Kingdom, Italy, Netherlands, Austria, Greece, Canada, Korea, Republic of, Mexico, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Adult patients, >= 70 years.
* Cancer of the colon or rectum.
* Metastatic disease diagnosed <= 6 months before enrollment.
* >= 1 measurable metastatic lesion.
Exclusion Criteria:
* Adjuvant anti-vascular endothelial growth factor (VEGF) treatment.
* Prior chemotherapeutic treatment for metastatic colorectal cancer.
* Past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix).
* Clinically significant cardiovascular disease.
* Current or recent daily use of aspirin (> 325 mg/day) or other non-steroidal anti-inflammatory drug (NSAID), or full dose anticoagulants.
|
NCT_ID
NCT00484939
|
Study_NameA Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer
| 6,776 |
Study Objectives
This study is designed to determine the safety, tolerability and maximum tolerated dose of Oral AP23573 in combination with Doxorubicin
Conditions: Cancer, Sarcoma
Intervention / Treatment:
DRUG: ridaforolimus, DRUG: Doxorubicin
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age >= 18 years with a histological/cytological diagnosis of advanced tumor, preferentially breast, sarcoma, ovarian, endometrial or other tumor types for which treatment with anthracycline therapy is indicated
* Prior cumulative doxorubicin exposure less than 400 mg/m2
* An ECOG performance status of 0 or 1
* Adequate cardiovascular function
* Measurable disease according to modified RECIST criteria
* Adequate hematological, renal and hepatic functions
* Able to understand and give voluntary written informed consent
Exclusion Criteria:
* Women who are pregnant or lactating
* Presence of active brain metastases. Patients with treated brain metastases will be eligible if they are on a stable dose of corticosteroids or are without change in brain disease status for at least 4 weeks following related therapy (e.g., whole brain radiation, surgery)
* Prior treatment with CCI-779, rapamycin, or any other mTOR inhibitor
* Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of AP23573; the interval is >= 2 weeks for signal transduction inhibitors with a half-life known to be <24 hours, and is >= 6 weeks for nitrosourea or mitomycin. Exception: Concurrent treatment with LHRH agonists is allowed for patients with prostate cancer.
* Ongoing toxicity associated with prior anticancer therapy other than alopecia and <= Grade 1 peripheral neuropathy by NCI toxicity criteria
* Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
* Known or suspected hypersensitivity to any excipient contained in the study drug
* Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
* Significant uncontrolled cardiovascular disease
* Any active infection requiring prescribed intervention
* Any other concurrent illness which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
* Any pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption
* Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for >= 2 weeks prior to first planned dose of study drug
* Concurrent treatment with medications that induce or inhibit cytochrome P450 (CYP3A)
* Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of AP23573
|
NCT_ID
NCT00288431
|
Study_NameSafety, Tolerability and Maximum Tolerated Dose of Oral AP23573 in Combination With Doxorubicin (8669-015)
| 1,306 |
Study Objectives
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women and men who have a type of breast cancer known as hormone receptor positive/HER2- breast cancer.
Conditions: Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
Intervention / Treatment:
DRUG: Tamoxifen, DRUG: Ribociclib, DRUG: Goserelin
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:
* Histologically and/or cytologically confirmed diagnosis of Estrogen Receptor-Positive (ER+) and/or Progesterone Receptor-Positive (PR+) breast cancer by local laboratory.
* Human Epidermal growth factor Receptor 2 Negative (HER2-) breast cancer defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative In Situ Hybridization (Fluorescence [FISH], Chromogenic [CISH], or Silver [SISH]) test is required by local laboratory testing.
* Participants are allowed (but not required) to have up to two lines of prior chemotherapy regimens in the metastatic setting for the dose expansion phase. For the dose escalation cohort, up to three previous lines of chemotherapy in the metastatic setting is acceptable.
* Measurable disease, i.e., at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria only *for expansion cohorts.
* For *escalation cohorts, bone only disease is allowed. For expansion cohorts, there must be measurable disease as stated above.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
* Written informed consent must be obtained prior to any screening procedures and according to local guidelines.
* Adequate bone marrow and organ function.
* Must be able to swallow ribociclib and Tamoxifen capsules/tablets.
* Pre-Menopausal Women Eligibility: 1) Pre-menopausal women who received adjuvant Aromatase Inhibitor and Ovarian Suppression (AI + OS) in the adjuvant setting and completed at least 12 months of hormonal therapy. 2) Pre-menopausal women with de novo metastatic disease are eligible if they have had no prior endocrine therapy. 3) Pre-menopausal women who have not received Tamoxifen in the metastatic setting, but have received up to two lines of chemotherapy.
* Post-Menopausal Women and Men Eligibility: 1) Post-menopausal women or men who have progressed on first-line or second line therapy with an aromatase inhibitor in the metastatic setting. 2) Post-menopausal women or men who have recurred while on or after completion of adjuvant treatment with aromatase inhibitors (they have completed at least one year of AI in the adjuvant setting before progression on AI). 3) Post-menopausal women or men who are not considered candidates for treatment with an aromatase inhibitory by their oncologist, patients not willing to go on AI, or patients who were intolerant to AI.
* Post-menopausal women or men are allowed (but not required) to have up to two lines of prior chemotherapy regimens in the metastatic setting for the dose expansion phase . For the dose escalation cohort, up to three previous lines of chemotherapy in the metastatic setting is acceptable.
Exclusion Criteria:
* Potential participants with inflammatory breast cancer.
* Prior CDK 4/6 inhibitor exposure.
* Have received Tamoxifen in the metastatic setting (for more than 30 days) or has progressed while on Tamoxifen in the adjuvant setting.
* Known hypersensitivity to ribociclib or excipients of tamoxifen.
* A concurrent malignancy or malignancy within 3 years of starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
* Central nervous system (CNS) involvement unless specific criteria are met.
* Impairment of Gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
* Known history of HIV infection (testing not mandatory).
* Any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
* Clinically significant, uncontrolled heart disease and/or a recent events as specified in the study protocol
* Currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug: a. Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges. b. That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. c. That have a known risk to prolong the QT interval or induce Torsades de Pointes. d. Herbal preparations/medications, dietary supplements not prescribed by an M.D..
* Currently receiving or has received systemic corticosteroids <=2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.
* The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
* Currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
* Participation in a prior investigational study within 30 days prior to enrollment..
* Has received radiotherapy <= 4 weeks or limited field radiation for palliation <= 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 25% of the bone marrow was irradiated.
* Has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).
* Has not recovered from all toxicities related to prior anticancer therapies to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade equal to or less than 1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study).
* A Child-Pugh score B or C.
* History of non-compliance to medical regimen or inability to grant consent.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.]
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation. There are specific guidelines regarding the various acceptable highly effective contraception methods. Note: The use of oral contraception is not allowed.
|
NCT_ID
NCT02586675
|
Study_NameTEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
| 11,494 |
Study Objectives
This phase I trial studies the side effects and best dose of pomalidomide in treating younger patients with tumors of the brain or spine (central nervous system) that have come back or are continuing to grow. Pomalidomide may interfere with the ability of tumor cells to grow and spread and may also stimulate the immune system to kill tumor cells.
Conditions: Neurofibromatosis Type 1, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Visual Pathway Glioma, Recurrent Primary Central Nervous System Neoplasm, Refractory Primary Central Nervous System Neoplasm
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, DRUG: Pomalidomide
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 received standard therapy (or generally accepted upfront therapy if no standard exists) and have no known curative therapy
* Patients with a histologically confirmed diagnosis of a primary CNS tumor that is recurrent, progressive or refractory to standard therapy; refractory disease will be defined as the presence of persistent abnormality on conventional magnetic resonance imaging (MRI) imaging that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment; all tumors must have histological verification at either the time of diagnosis or recurrence except for patients with diffuse intrinsic brain stem tumors or optic pathway gliomas; patients with neurofibromatosis type-I (NF-1) associated CNS tumors are eligible if they meet all other eligibility criteria
* Patients must have evaluable disease on MRI imaging
* Patients must have body surface area (BSA) > 0.55 m^2 at the time of enrollment
* In the event of de-escalation from dose level 1 to dose level 0, patients with BSAs < 0.67 m^2 are not eligible
* Patients must have recovered from clinically significant, acute, treatment-related toxicities of prior therapies; for those acute baseline adverse events attributable to prior therapy, recovery is defined as a toxicity grade =< 2, using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0, unless otherwise specified in the inclusion and exclusion criteria
* Agents that potentially fit into more than one category or do not clearly fit into any category listed above should be discussed with the study principal investigator (PI) prior to enrollment
* Patients must have received their last dose of known myelosuppressive anticancer therapy greater than 28 days prior to study enrollment or > 42 days if nitrosourea
* Patients must have received their last dose of any other investigational agent greater than 28 days prior to enrollment (with exception of fluorothymidine F-18 [FLT])
* Patients must have received their last dose of any other biologic agent greater than 7 days prior to enrollment
* Patients must have received their last dose of any other biologic agent greater than 7 days prior to enrollment
* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur and discussed with the PI
* Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment
* Immunomodulatory therapy: greater than 28 days must have elapsed since last dose of an immune modulating agent, including vaccine therapy
* Administration of the radioisotope, 18-FLT, which is being concurrently investigated on an imaging study within the Pediatric Brain Tumor Consortium (PBTC), is allowed > 72 hours prior to initiation of pomalidomide on this study; any adverse events related to the FLT must have resolved completely
* Patients must have had their last fraction of:
* Craniospinal irradiation, total body irradiation (TBI), or >= 50% radiation of pelvis > 3 months prior to enrollment
* Focal irradiation > 6 weeks prior to enrollment
* Local palliative radiation therapy (XRT) (small port) >= 4 weeks
* Patient must be:
* >= 6 months since allogeneic bone marrow transplant prior to enrollment
* >= 3 months since autologous bone marrow/stem cell prior to enrollment
* >= 3 months since stem cell transplant or rescue without TBI with no graft vs. host disease prior to enrollment
* No graft versus host disease
* Patients on anticonvulsant therapy may continue these at the discretion of their treating physician; however, it is recommended that anticonvulsant levels be checked periodically as clinically indicated if possible
* Patients on alternative supplements should strongly be encouraged to discontinue them prior to enrollment; if they opt to continue, they may enroll on study as long as they have been receiving the supplement for at least 30 days, there is NO evidence of hepatic, renal or other organ dysfunction, administration is approved by the PI, and administration is documented in the study diary
* Patients must be on a stable or decreasing dose of corticosteroids for 5 days prior to enrollment; patient may be taking therapeutic doses of steroids during the initial dose escalations and prior to defining an RP2D; this should be recorded in the database; once the RP2D has been established, enrollment may be limited based on steroid use;*physiologic replacement doses will be defined on this protocol as no more than 0.75 mg/m^2/day of dexamethasone or equivalent of steroids; doses higher than this will be considered therapeutic
* All races and ethnic groups are eligible for this study
* Patients should have no significant worsening in clinical status for a minimum of 2 days prior to enrollment
* Patients must be able to swallow whole capsules
* Patients should undergo a repeat MRI prior to enrollment if there is a significant worsening or new neurologic symptoms in the interval between the eligibility scan and start of protocol therapy
* The repeat scan will act as a new baseline and the eligibility scan for these patients
* Karnofsky performance scale (KPS for > 16 years) or Lansky performance score (LPS for =< 16 years) assessed within 14 days of enrollment must be >= 50
* Absolute neutrophil count >= 1,000/mm^3
* Platelets >= 100,000/mm^3 (unsupported, defined as no platelet transfusion within 7 days and recovery from nadir)
* Hemoglobin >= 8 g/dL (may receive transfusions)
* Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal
* Albumin >= 3 g/dL
* Serum creatinine based on age/gender as noted; patients that do not meet the criteria below but who have a 24-hour creatinine clearance or glomerular filtration rate (GFR) (radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are eligible
* Serum creatinine for age/gender
* 3 to < 6 years: 0.8 mg/dL
* 6 to < 10 years: 1 mg/dL
* 10 to < 13 years: 1.2 mg/dL
* 13 to < 16 years: 1.5 mg/dL (male) and 1.4 mg/dL (female)
* >= 16 years: 1.7 mg/dL (male) and 1.4 mg/dL (female)
* Oxygen saturation as measured by pulse oximetry must be >= 93% on room air
* Patients must be off all colony-forming growth factor(s) for at least 1 week prior to enrollment (i.e. filgrastim, sargramostim); two weeks must have elapsed if patients received polyethylene glycol (PEG) formulations
* Pregnant or breast-feeding patients are excluded; female patients of childbearing potential must have a negative serum or urine pregnancy test at the time of enrollment; in addition, female patients of childbearing potential must have negative pregnancy tests within 10 - 14 days prior to starting pomalidomide (can use enrollment pregnancy test if within the 10 <= age <= 14 day limit) AND again within 24 hours prior to initiation of pomalidomide; this protocol defines the following childbearing potential risk categories as:
* Female child/young adult of childbearing potential as a female who has:
* Achieved menarche and/or breast development, in Tanner stage 2 or greater
* Has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Note: amenorrhea following cancer therapy does not rule out childbearing potential
* Patients of childbearing or child fathering potential must use medically acceptable form(s) of birth control as stated within the pomalidomide Pregnancy Risk Minimization Plan, which includes abstinence, while being treated on this study; true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
* Female patients of childbearing potential agree to and will have had effective contraception without interruption for 28 days before starting pomalidomide
* The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines
Exclusion Criteria:
* Patients with any clinically significant unrelated systemic illness (e.g., serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results
* Patients with a history of any other malignancy will not be eligible
* Patients with radiation-associated gliomas will not be eligible
* Patients with a history of non-central line related thrombosis, more than one prior central-line related thrombosis, or known coagulopathy will not be eligible; patients with a first degree family member with a known coagulopathy will be excluded, and therefore, obtaining a family history is essential when possible; patients actively on anticoagulation therapy are not eligible
* Patients with a prior history of serious allergic reactions associated with thalidomide or lenalidomide
* Patients who are receiving any other anti-cancer or investigational drug therapy are excluded
* Patients taking a known moderate to potent inhibitor of CYP1A2 are excluded; pomalidomide is primarily metabolized by CYP1A2 and CYP3A; pomalidomide is also a substrate for permeability (P)-glycoprotein (P-gp)
* Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions
* Patients who have received pomalidomide in the past are not eligible; patients who have prior treatment with other immunomodulatory drugs (IMiDs) (thalidomide, lenalidomide) ARE eligible if they meet all other eligibility criteria and did not have "significant toxicity" associated with lenalidomide or thalidomide use; a "significant" toxicity will be defined as one that required a dose reduction or discontinuation due to toxicity; please discuss any questions with the PI
|
NCT_ID
NCT02415153
|
Study_NamePomalidomide in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
| 21,976 |
Study Objectives
Italian, multicentre, non comparative trial in patients with advanced Colorectal Cancer(CRC)and KRAS wild-type, defined by molecular evaluation.
Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity developed or patient refusal.
The aim of this study is to assess the prognostic role of PTEN in terms of Progression free survival.
Although the role of Cetuximab as first line treatment in metastatic CRC will be soon established, it is still unclear which is the best schedule for Cetuximab and the role of biological factors in order to select the most appropriate subset of pts for recommending Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the perspective to study the role of other molecular markers in this subset of pts.
On the basis of these considerations this study is aimed at testing a different schedule of Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: Cetuximab, DRUG: FOLFIRI
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion criteria
* Signed written informed consent for biological analysis (all pts)
* Signed written informed consent for enrolment (pts with KRAS wild type)
* Male or female aged > or = 18 years
* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* KRAS evaluation availability with wild-type result
* Metastatic CRC not suitable for curative-intent resection
* Availability of tumour samples (or able and willing to provide tumour sample) and blood for biological analysis
* Presence of at least one lesion measurable unidimensionally by computed tomography (CT) scan or magnetic resonance imaging (MRI). (index lesion(s) must not lie within an irradiated area)
* Eastern cooperative oncology group-performance status (ECOG-PS) <2
Exclusion criteria
* Brain metastasis (known or suspected)
* Previous chemotherapy for metastatic CRC (any). Adjuvant therapy is allowed if the chemotherapy treatment free interval is > 6 months
* Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
* Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
* Any investigational agent(s) within 4 weeks prior to entry
* Previous exposure to HER-axis -pathway targeting therapy
* Leucocytes <3.0 x 109/L and neutrophils <1.5 x 109/L, platelets <100 x 109/L, and hemoglobin <9 g/dL
* Bilirubin level either normal or >1.5 x ULN
* ASAT and ALAT >2.5 x ULN (>5 x ULN if liver metastasis are present)
* Serum creatinine >1.5 x ULN
* Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
* Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
* Pre-existing neuropathy > grade 1
* Known grade 3 or 4 allergic reaction to any of the components of the treatment
* Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Pts with a previous malignancy but without evidence of disease for > or equal 5 years will be allowed to enter the trial)
* Pregnancy or lactation
* Inadequate contraception (male or female pts) if of childbearing or procreational potential
* Known drug abuse/ alcohol abuse
* Legal incapacity or limited legal capacity
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
|
NCT_ID
NCT01068132
|
Study_NamePrognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.
| 15,707 |
Study Objectives
The purpose of this study is to assess the feasibility and efficacy outcomes of neoadjuvant modified FOLFIRINOX and postoperative gemcitabine in patients with borderline resectable pancreatic cancer.
Conditions: Pancreatic Adenocarcinoma
Intervention / Treatment:
DRUG: Preoperative modified FOLFIRINOX and postoperative gemcitabine
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients aged 19 years and older
* Cytologically or histologically confirmed adenocarcinoma of the pancreas
* Met the NCCN criteria for borderline resectable disease (assessed at Aug 23rd, 2015)
* No previous chemotherapy or radiotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 1
* Adequate bone marrow function as defined by platelets >= 100 x 109/L and neutrophils >= 1.5 x 109/L
* Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN)
* Adequate hepatic function with serum total bilirubin < 2 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
* No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other non life-threatening cancer (i.e., prostate or thyroid cancer) except where treated with curative intent > 5 years previously without evidence of relapse
* Written informed consent to the study
Exclusion Criteria:
* No potentially resectable disease or no metastatic disease
* Locally advanced unresectable disease according to the NCCN criteria
* Histologically confirmed adenosquamous carcinoma
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance
* Last dose of radiotherapy received within 4 weeks before the start of study treatment, excluding palliative radiotherapy
* Obstruction of gastrointestinal tract
* Active gastrointestinal bleeding
* Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
* Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
* Female subjects who are pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug. A highly effective method of contraception is defined as having a low failure rate (< 1% per year) when used consistently and correctly.
|
NCT_ID
NCT02749136
|
Study_NameNeoadjuvant Modified FOLFIRINOX in Borderline Resectable Pancreatic Cancer
| 10,230 |
Study Objectives
Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard administration dose and schedule. This application is a non-labeled indication for cabazitaxel and will inform future drug development in gastroesophageal malignancies, where docetaxel remains an approved first line agent, but is not routinely used due to excessive toxicity and marginal efficacy.
At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel in refractory gastric cancer, with preferential activity in one or more gastric cancer subtypes
Conditions: Gastric Adenocarcinoma, Gastroesophageal Adenocarcinoma, Distal Esophageal Adenocarcinoma
Intervention / Treatment:
DRUG: Cabazitaxel
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:
* Subject must have histologically or cytologically confirmed gastric, or gastroesophageal adenocarcinoma, or distal esophageal adenocarcinoma.
* Subject must have unresectable or metastatic gastroesophageal adenocarcinoma.
* Subject must have evaluable disease as per RECIST criteria.
* Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed.
* Age >=18 years.
* ECOG performance status status >= 2
* Subject must have normal organ and marrow function as defined below:
* WBC >= 3,000/uL
* Total Bilirubin <= 1.5 x upper limits of normal
* AST (SGOT) <= 2.5 x upper limits of normal
* ALT (SGPT) <= 2.5 x upper limits of normal
* Hgb > 7.5 g/dl (without transfusion within 7 days)
* ANC > 1000 /ml
* Plt > 75 K/ml (without transfusion)
* Creatinine* < 2.0 g/dl *or a calculated creatinine clearance > 45/cc (using Cockroft-Gault formula)
* 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. 10. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Subject with previously untreated unresectable or metastatic gastroesophageal adenocarcinoma.
* Subject with more than 2 prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma.
* Subject with CNS metastases with active neurologic dysfunction. These patients are excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse event.
* Significant medical co-morbidity that would preclude safe administration of cytotoxic therapy, including but not limited to:
a.Cardiac disease i. Unstable angina ii. Myocardial infarction < 3 months prior to study initiation b. Ongoing serious infection i. Bacteremia or sepsis requiring intravenous antibiotics ii. HIV with AIDS defining illness c.Inadequate oral nutritional intake i. Requirement for daily intravenous fluids or total parenteral nutrition. d. Psychiatric illness/social situations that would limit compliance with study requirement
* Subject who has 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 prior treatment related toxicity with persistent symptoms >= grade 2 due to agents administered more than 4 weeks earlier.
* Subject may not receive another investigational agent.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cabazitaxel, or to drugs formulated with polysorbate 80.
* Pregnant (positive pregnancy test) and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
|
NCT_ID
NCT01757171
|
Study_NamePhase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
| 18,047 |
Study Objectives
The objective of this registry is to collect data on patient demographics, medical history, change in prostate, bone and overall health of the patients receiving androgen ablation treatment using Eligard. Data collected through this national registry program provides an opportunity to increase knowledge of efficacy and safety of the long term treatment with Eligard, provide a platform to better identify patient segments for the therapy with Eligard®. Furthermore registries are the only tools to accurately capture rare adverse events.
Conditions: Cancer of the Prostate
Location: Canada
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Patients > 18 years.
* Histologically confirmed diagnosis of locally Advanced or Metastatic Prostate Cancer.
* Patient starting an androgen deprivation therapy with Eligard at 3 or 4 month treatment frequency per standard of care.
* Signed written informed consent.
Exclusion Criteria:
* Prior ADT (within 6 months).
* Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
* Life expectancy less than 2 years.
|
NCT_ID
NCT00992251
|
Study_NameEligard Observational Registry for Patients With Prostate Cancer
| 21,834 |
Study Objectives
The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.
Conditions: Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
Intervention / Treatment:
DRUG: ONTAK
Location: Poland, Germany, United States, United Kingdom, Australia, Netherlands, Austria, Canada, Russian Federation, Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab;
* Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy;
* Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry.
* Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months.
* Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
* No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease.
* No systemic infections;
* Willingness to be randomized to a placebo treatment only arm;
* ECOG performance status 0 or 1;
Exclusion Criteria:
* Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
|
NCT_ID
NCT00050999
|
Study_NameStudy of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients
| 10,173 |
Study Objectives
The study is to evaluate the efficacy of KL-A167 a in subjects with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Overall Response Rate (ORR) per the Lugano Classification
Conditions: Classical Hodgkin Lymphoma
Intervention / Treatment:
DRUG: KL-A167
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* 18 years and older
* Histopathological confirmed classical Hodgkin's lymphoma
* Relapsed/refractory cHL include：subject with no response to or with progression after ASCT ；subject which failed failed second line and above chemtherapy；subject which didn't achieve PR after 2 cycles or didn't achieve CR after 4 cycles
* At least one measurable disease (long axis>15 mm and short axis>5 mm,or both axis>10 mm）
* ECOG performance status of 0 or 12
* Subject must have adequate organ functions and meet requirements on laboratory values.：Count of Blood Cells: absolute neutrophil count (ANC) >= 1.0 × 109 / L; platelet count (PLT) >= 50 × 109 / L; hemoglobin content (HGB) >= 7.0 g / Dl; Liver function: serum total bilirubin (TBIL) <= 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 × ULN，with the exception of patients with hepatic metastases (ALT and AST <= 5 × ULN) and patients with hepatic metastases or Gilbert's syndrome (total bilirubin <= 3 × ULN)Renal function: serum creatinine (Cr) <= 1.5 × ULN or Creatinine clearance rate（CCR）>=50 mL/min；International normalized ratio (INR) <= 1.5 x ULN ；Thyroid function: thyroid stimulating hormone (TSH) in normal range.
* Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy (including Chinese herbal medicine and Chinese patent medicine) used to control cancer including locoregional treatment must have been completed >= 4 weeks before the first dose of KL-A167(Mitomycin or nitroso must have been completed >= 6 weeks), and all treatment-related adverse events (except alopecia) are stable and have either returned to baseline or Grade 0/1
* Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 6 months after the last dose of study medication
* Subject has voluntarily agreed to participate by giving written informed consent.
Exclusion Criteria:
* Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma.
* Known central nervous system lymphoma.
* Prior malignancy except for curatively treated carcinoma in situ of the cervix or breast ，Superficial bladder cancer，and Squamous cell carcinoma in situ
* History of severe hypersensitivity reaction to monoclonal antibodies
* Prior exposure to any anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.
* need the other anticancer therapy during the study
* Received any anticancer vaccine or other medications for immunomodulatory receptor preparations
* Received HSCT
* Received ASCT in the past 3 months
* Serious acute or chronic infection requiring systemic therapy.
* Subject with active autoimmune disease or history of autoimmune disease with high risk of recurrence.
* Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily Prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of KL-A167
* serious medical diseases, ex Suffering from heart failure (New York Heart Association standard III or IV), ischemic heart disease (such as myocardial infarction or angina), congestive heart failure and other cardiovascular diseases, uncontrolled diabetes(fasting blood glucose>=10 mmol/L), uncontrolled high blood pressure(Systolic> 150 mmHg and / or diastolic> 100 mmHg), LVEF<50%
* QTcF>450 msec
* Known active HBV or HCV infection.
* Known HIV infection.
* Has history of interstitial lung disease or non-infectious pneumonitis. Subjects with prior drug-induced or radiation-induced pneumonitis who are asymptomatic are eligible.
* Known active pulmonary tuberculosis
* Has history of AE related with immune system during the Immunotherapy
* Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
* Known neurological or psychiatric diseases
* Ongoing alcohol or drug abuse
* Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding
* Participation in another clinical trial within the past 4 weeks
* Other significant disease that in the investigator's opinion should exclude the subject from the trial
|
NCT_ID
NCT03580564
|
Study_NameAn Open, Multicenter Phase II Study to Evaluate the Safety and Efficacy of KL-A167 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma
| 16,157 |
Study Objectives
This current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Testosterone Implant
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Female patients treated between March 2008 - March 2013
* Women who received at least two testosterone pellet insertion procedures
* Women previously accrued to the prospective cohort study
Exclusion Criteria:
* Pre-existing breast cancer
* Women who received a single testosterone pellet insertion
|
NCT_ID
NCT03768258
|
Study_NameTestosterone Implants and the Incidence of Breast Cancer
| 3,627 |
Study Objectives
The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.
Conditions: Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Metastases, Neoplasm
Intervention / Treatment:
DRUG: Motexafin Gadolinium
Location: Germany, United States, Australia, Netherlands, Austria, Belgium, Canada, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Adults (>=18 years) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer;
* KPS score of >=70;
* Each patient must sign a study-specific Informed Consent form
Exclusion Criteria:
* Liver metastases;
* Extracranial metastases in two or more organs;
* Known leptomeningeal metastases or subarachnoid spread of tumor;
* Prior whole brain radiation;
* Plan to use radiosurgery or radiation boost after completion of WBRT;
* Planned chemotherapy during study treatment (prior and subsequent chemotherapy is allowed);
* Prior total resection of a single brain metastasis;
* Laboratory values as follows:
LDH > 1.3 x upper limit of normal (ULN); ANC < 1500 /mm³; Platelets < 50,000 /mm³; Creatinine > 2.0 mg/dL; AST or ALT > 2 x ULN; Total bilirubin > 2 x ULN;
* Women who are pregnant or lactating
|
NCT_ID
NCT00054795
|
Study_NameStudy of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
| 13,931 |
Study Objectives
The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).
Conditions: Peripheral T-cell Lymphoma
Intervention / Treatment:
DRUG: SP-02L (darinaparsin for injection), DRUG: SP-02L (darinaparsin for injection), DRUG: SP-02L (darinaparsin for injection)
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Japanese patients aged >= 20 years at the day of obtaining the informed consent
* Patients with histologically confirmed diagnosis of the following:
* Peripheral T-cell Lymphoma, not otherwise specified (PTCL-NOS)
* Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)
* Angioimmunoblastic T-cell Lymphoma (AITL)
* Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy)
* Have at least 1 evaluable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy of at least 3 months
|
NCT_ID
NCT01435863
|
Study_NameA Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
| 2,693 |
Study Objectives
Hematopoietic stem cells (HSC) are used to support the administration of high dose chemotherapy for a range of human cancers. For a safe HSC transplantation, a minimum of 5 million HSC per kilogram are required. HSC are collected from the bone marrow by using drugs such as G-CSF (filgrastim) which 'mobilize' them from the bone marrow into the bloodstream. HSC are collected from the bloodstream using an apheresis machine. Between 5 and 60% of patients fail to mobilize the minimum HSC dose required for safe transplantation, and this trial is investigating a way to enhance mobilization to overcome this problem. This trial aims to determine if a new vitamin A derivative is capable of enhancing HSC mobilization when used in conjunction with G-CSF. Patients will undergo two mobilization procedures. They will be given G-CSF alone, or a combination of the study drug plus G-CSF, and their stem cells will be collected. A comparison group of patients will be given G-CSF alone for both mobilizations. Stem cells collected from patients in this trial will be frozen and stored until they are required for transplantation into that patient. At that time, patients will be monitored for how well they recover from their high dose chemotherapy and HSC transplantation.
Conditions: Multiple Myeloma, Lymphoma
Intervention / Treatment:
DRUG: VTP195183
Location: Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Age 18 <= age <= 70
* Histologically proven multiple myeloma or lymphoma
* Intent of treating physician to proceed to high dose therapy and autologous transplantation
* Not currently receiving thalidomide (within 1 week of commencing VTP195813 or G-CSF), cytotoxic agents or high dose prednisolone or Dexamethasone (at doses greater than 15 mg prednisolone or equivalent per day)
* Multiple myeloma patients must be taking regular bisphosphonate therapy
* Absolute neutrophil count between 1.5 and 10 x 109/L
* ECOG performance status ? 2
* Life expectancy of at least 2 months
* Written informed consent signed by patient or legally authorized representative
Exclusion Criteria:
* Active infection or a fever > 38.2 degrees C (fever due to B symptoms in lymphoma patients will not exclude a patient)
* Use within the previous 30 days of other vitamin A preparations within the last 30 days (including oral vitamin supplements, oral retinoids for acne or other skin disorders, bexarotene, or topical vitamin A preparations)
* Pregnancy or breast feeding. Women of child-bearing potential, admitted to the trial must take adequate measures to prevent conception (at least two different forms of contraception during the study and for at least one month after completion of study drugs) and are to undergo a pregnancy test
* Significant non-malignant disease including HIV infection, uncontrolled hypertension (diastolic blood pressures > 115 mmHg), unstable angina
* Known allergy to E.coli-derived products
* Current treatment with tetracycline antibiotics
|
NCT_ID
NCT00234169
|
Study_NameA Study of Peripheral Blood Progenitor Cells Mobilisation (PBPC) With VTP195183 Plus Granulocyte-Colony Stimulating Factor (G-CSF) Compared to Mobilisation With G-CSF Alone
| 11,252 |
Study Objectives
The purpose of this research study is to determine if ranibizumab can prevent the growth of neurofibromas. We will also be collecting extra blood and serum samples to help us learn more about NF1. Ranibizumab is a drug that affects the development of blood vessels that feed tumors. It targets a substance in the body called VEGF (Vascular Endothelial Growth Factor). VEGF helps tumors to grow and survive by supporting the growth of blood vessels that bring nutrients to the tumor. VEGF is made by cancerous tumors and also by non-cancerous tumors such as neurofibromas.
Conditions: Neurofibromatosis Type 1, Cutaneous Neurofibromas
Intervention / Treatment:
DRUG: Ranibizumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must have diagnosis of NF1 based on NIH criteria with two or more of the following characteristics: a) Six or more cafe-au-lait macules b) Skin fold freckling in the axilla or groin c) Optic pathway glioma d) Two or more Lisch nodules of the iris e) Distinctive bony lesions such as dysplasia of the sphenoid wing or of a long bone such as the tibia f) Two or more neurofibromas of any type or 1 or more plexiform neurofibroma g) First degree relative with NF1
* At least four cutaneous neurofibromas on skin exam with the following qualities: a) the lesion must be discrete by clinical exam and must be at least 5mm away from another skin tumor b) the lesion must be amenable to measurement with calipers with minimum dimension of 5mm and maximum dimension of 20mm c)the lesions cannot be located on the face, scalp, or groin and must be located in an area that can be photographed d) histologic confirmation of tumor type is not required in the setting of compatible clinical setting
* Must be willing to have treated CNF surgically removed during the study
* 18 years or older
* Normal organ and marrow function as described in the protocol
Exclusion Criteria:
* Pregnant or breast-feeding women
* Chemotherapy or radiotherapy within 6 weeks prior to entering the study
* Receiving any other investigational agent
* History of allergic reactions attributed to compounds of similar chemical or biologic composition as ranibizumab
* Hypertension that cannot be controlled by medications
* Known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhages in the past
* NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
* Uncontrolled intercurrent illness
|
NCT_ID
NCT00657202
|
Study_NameRanibizumab for Neurofibromas Associated With Neurofibromatosis 1
| 16,312 |
Study Objectives
This research is being done to determine if combining an investigational drug called Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose chemotherapy.
Conditions: CD20+, B-cell Lymphomas, Mantle Cell Lymphoma, Non-Mantle Cell Low Grade B Cell Lymphomas (SLL/CLL), Transformed Lymphoma/DLBCL/PMBCL, Hodgkin's Disease, Gray Zone Lymphoma
Intervention / Treatment:
DRUG: Everolimus, BIOLOGICAL: Rituximab
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:
* Age >18 years
* ECOG performance status <= 2
* INR <= 2
* Adequate renal and hepatic function defined as a serum creatinine <2.0mg/dL, total bilirubin <5mg/dL, and AST and ALT ˂ 2.5 ULN.
* Platelet count >75 x 109/L
* Hemoglobin >10mg/dL
* ANC >3.0x109/L
* Fasting serum cholesterol <=300 mg/dL OR <=7.75 mmol/L and fasting triglycerides <= 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
* A willingness to use an accepted and effective method of birth control for sexually active women of childbearing potential during the study and for 8 weeks after the end of study drug treatment.
* Ability to sign informed consent
Exclusion Criteria:
Patient who have previously received an mTor inhibitor
* Patients who are pre-terminal or moribund
* Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of Everolimus (including chemotherapy, radiation therapy, antibody based therapy, etc.)
* Uncontrolled diabetes mellitus as defined by HbA1c>8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary
* Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled cortosteroids are allowed
* Patients who have received live attenuated vaccines within 1 week of start of Everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines. Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines;
* Patients who have a history of another primary solild malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >=3 years;
* 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;
* Patients with active bacterial or fungal infections requiring oral or intravenous antimicrobials are not eligible until resolution of the infection
* Female patients who are pregnant or breast feeding, or of reproductive potential whoe are not using effective birth control methods. Adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug.
* Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
* Patients with known intolerance to rituximab
* Known history of HIV or Hepatitis C
* Active Hepatitis B as defined by seropositivity for hepatitis B surface antigen. Subjects with positive hepatitis B core antibody titers and normal liver transaminases are allowed provided that prophylaxis is administered per institutional guidelines. Please see Addendum 8 for the action to be taken for patients with positive baseline hepatitis B results.
|
NCT_ID
NCT01665768
|
Study_NameMaintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
| 9,789 |
Study Objectives
Stress reactions caused by surgical stimuli can cause sympathetic nervous system activation and increased stress hormones, such as catecholamines, inflammatory cytokines, and pituitary hormones, and insulin resistance. In addition, increased catecholamine levels may exacerbate postoperative outcomes, especially delayed wound recovery, increased cardiovascular and respiratory complications, and immunosuppression. In particular, it is important to reduce the stress response for cancer patients during surgery because they are already immunocompromised status and more vulnerable to perioperative stressful situation. However, there are insufficient results on the benefits of deep neuromuscular block in these patients, although some have reported a reduction of postoperative pain and fewer complications in the deep neuromuscular block compared with moderate neuromuscular block. Therefore, the investigators aim to investigate the difference in the stress response of patients who received conventional moderate neuromuscular block or deep neuromuscular block in robot-assisted gastric cancer surgery.
Conditions: Stomach Cancer
Intervention / Treatment:
DRUG: Deep neuromuscular block with 'rocunium®', DRUG: Moderate neuromuscular block with 'rocunium®'
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion Criteria:
* 1. ASA Ⅰ - Ⅱ patients between 20 and 65 years undergoing robot-assisted gastric cancer surgery
Exclusion Criteria:
* 1. Patients with neuromuscular disease
* 2. Hypertensive patients with β-blockers
* 3. Diabetic patients receiving insulin therapy
* 4. Patients with severe heart (EF <45%), kidney (GFR <60), liver dysfunction (ALT / AST> 100)
* 5. Patients with obesity (BMI >=30)
* 6. Do not understand Korean language
* 7. For vulnerable subjects who are unable to obtain consent
|
NCT_ID
NCT03937440
|
Study_NameThe Effect of Deep Neuromuscular Block on the Perioperative Stress Response Reduction and Postoperative Recovery Enhancement in Robot-assisted Stomach Cancer Surgery
| 10,921 |
Study Objectives
Hyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant gliomas.
Conditions: Glioma, Glioblastoma Multiforme, Astrocytoma
Intervention / Treatment:
RADIATION: Conventional RT, RADIATION: Hyperfractionated RT, DRUG: Carmustine
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histopathologically confirmed glioblastoma multiforme (with areas of necrosis), malignant astrocytoma and astrocytoma with foci of anaplasia
* Karnofsky Performance Score >= 60
* Absolute Neutrophil count >= 1,500
* Platelets >= 100,000
* BUN <= 25
* Creatinine <= 1.5
* Bilirubin <= 2.0
* Hemoglobin >= 10 gm
* SGOT < 2 x upper limit of normal
* SGPT < 2 x upper limit of normal
Exclusion Criteria:
* No prior radiation to the head or neck area, chemotherapy or radiosensitizer
* No malignancy with the past five years except non-melanomatous skin cancer or carcinoma in-situ of the cervix
|
NCT_ID
NCT03722355
|
Study_NameHyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma
| 10,817 |
Study Objectives
The purpose of this study is to examine the combination of one standard treatment for lung cancer plus an additional drug, hydroxychloroquine. The standard treatment for lung cancer being used includes 2 chemotherapy drugs, called paclitaxel and carboplatin. Some patients who have a specific type of lung cancer can also receive another drug, a drug that targets blood vessels, called bevacizumab (also known as avastin). Hydroxychloroquine is an FDA approved drug for the treatment of malaria, rheumatoid arthritis and lupus erythematosis.
Conditions: Non-small Cell Lung Cancer, Advanced Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer
Intervention / Treatment:
DRUG: Paclitaxel, DRUG: Carboplatin, DRUG: Hydroxychloroquine, DRUG: Bevacizumab
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:
* Signed a protocol-specific informed consent.
* 18 years or older.
* ECOG Performance Status 0 or 1.
Cancer criteria:
* Histologically or cytologically confirmed non-small cell lung cancer. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirate or biopsy. Sputum cytology alone is not sufficient.
* Advanced stage NSCLC (stage IVa ((malignant pleural effusion (is now staged as stage IVa by the most recent staging system), or stage IV, or recurrent disease)).
* Measurable disease according to RECIST criteria.
* Patient with CNS metastasis are required to have stable disease documented by being off treatment (surgery, or Whole Brain radiation therapy) for at least 2 weeks, and four (4) weeks is preferred. No delay in onset of therapy is required for those patients who undergo stereotactic RT to the brain lesion(s). A contrast enhanced brain CT or brain MRI is required within 35 days of enrollment. Patients with brain metastases who qualify for protocol therapy will be included in Cohort 2 (ineligible for treatment with Bevacizumab).
* Prior radiation to sites other than the brain is allowed, if completed at least 2 weeks before treatment and provided that all radiation-related toxicities have resolved to <= Grade 1. Stereotactic irradiation to any site excludes the need for a waiting period.
Laboratory requirements
* Adequate organ function, as evidenced by ALL the following:
* absolute neutrophil count (ANC) >= 1500/mm³
* platelet count >= 100,000/mm³
* hemoglobin >= 9 gm/dL
* total bilirubin <= 1.5 x ULN; if patient has Gilbert's disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin <= 2 X institutional ULN.
* AST and ALT <= 2.5 x ULN in the absence of liver metastases; AST and ALT <= 5 x ULN in the presence of liver metastases
* alkaline phosphatase <= 2.5 x ULN
* creatinine <= 1.5 X institutional ULN or calculated creatinine clearance >= 60 ml/min as estimated using the Cockcroft-Gault formula.
Comorbidities For Cohort 1: (Bevacizumab eligible)
* For patients who have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipate the need for such while on active treatment, may participate and receive Bevacizumab at the start of the second or third cycle as they would under standard care. Placement of vascular access device is not considered major surgery, but the incision must have healed before initiation of treatment.
* Patients must have a systolic blood pressure <= 150 mm Hg and diastolic blood pressure <= 100 mm Hg (the use of antihypertensive medications to achieve these goals is allowed).
* Adequate organ function
* INR <= 1.5 and aPTT WNL.
* Urine Protein Creatinine (UPC) ratio < 1.0 or 24 hour urine protein ratio < 1000 mg
UPC ratio of spot urine is an estimation of the 24 urine protein excretion. A UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. To obtain a UPC ratio:
* Obtain at least 4 mL of a random urine sample
* Determine protein and creatinine concentration
* Calculate the UPC using one of the following formulae [urine protein]/[urine creatinine] - if both values are reported in mg/dL [(urine protein) x 0.088]/[urine creatinine] - if urine creatinine is reported in mmol/L
For ALL (Cohort 1 and Cohort 2):
* Women must:
* Have a negative serum or urine pregnancy test within 7 days prior to study entry if she is a woman of child-bearing potential, OR
* Be at least one year post-menopausal, OR
* Be surgically sterile
* Patients of childbearing or child fathering potential must be willing to use an acceptable method of birth control prior to study entry and for the duration of the study. Acceptable methods of contraception include hormonal, barrier methods, intrauterine device, tubal ligation/vasectomy or abstinence.
Exclusion Criteria:
Cancer criteria:
* No prior cytotoxic chemotherapy or targeted therapy in the advanced or metastatic setting. Post-operative adjuvant therapy for previously resected NSCLC is allowed as long as the last dose was given greater than 1 year before study entry, and there is current evidence of disease progression.
* No active malignancy other than NSCLC. Patients with a history of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast within the past 3 years must have been treated with curative intent. Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for > 3 years.
Comorbidities
For Cohort 1: (Bevacizumab eligible)
* No history of gross hemoptysis (defined as bright red blood of a half-teaspoon or more) within 3 months prior to enrollment.
* None of the following conditions within 6 months prior to enrollment: myocardial infarction, stroke or symptomatic peripheral vascular disease.
* No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment.
* No serious non-healing wound, ulcer or bone fracture.
* Patients must not have unstable angina or NYHA classification of congestive heart failure of Grade >= 2.
* No history of significant vascular disease (eg aortic aneurysm).
* No current or recent (within 28 days of enrollment) full dose anticoagulants or thrombolytic agents.
For Cohort 2 (Bevacizumab ineligible):
* None of the following conditions within 6 months prior to enrollment: myocardial infarction, stroke or symptomatic peripheral vascular disease.
* Patients must not have unstable angina or NYHA classification of congestive heart failure of Grade >= 2.
* No history of significant vascular disease (eg aortic aneurysm).
For ALL (Cohort 1 and Cohort 2):
* Patients must not have psoriasis or porphyria.
* No known hypersensitivity to 4-aminoquinoline compound.
* Patients must not have known or suspected G-6P deficiency.
* No know bleeding diathesis or coagulopathy.
* No known GI pathology that would interfere with drug bioavailability.
* No peripheral or sensory neuropathy > Grade 1 at study entry.
* No known prior hypersensitivity to carboplatin, paclitaxel, bevacizumab or hydroxychloroquine or any of their components.
* No ongoing or active infection at study entry.
* Patients must not be receiving treatment for rheumatoid arthritis or systemic lupus erythematosus.
* Patients must not have HIV or be taking HAART therapy.
* Patients must not have a history of any condition (social or medical) that, in the opinion of the Investigator, might interfere with the patient's compliance with the protocol or pose additional or unacceptable risk to the patient.
* Women must NOT be pregnant or breastfeeding.
* Must not be taking hydroxychloroquine for treatment or prophylaxis of malaria.
|
NCT_ID
NCT01649947
|
Study_NameModulation of Autophagy in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - Phase II
| 22,299 |
Study Objectives
Early detection of melanoma showed an impact on the thickness of the lesions at the time of diagnosis. One challenge is to improve the modalities.
Decrease the rate of non-compliant patients among patients referred to the dermatologist for a suspicious lesion (patients who will never go to the consultation), and reduce the time interval between the first identification of the lesion and the excision allowing the diagnosis are major issues.
Direct contact between the general practitioner (GP) and the dermatologist would probably make it possible to shorten the care pathway of patients with lesions justifying excision.
The objective is to evaluate whether contacting the dermatologist directly by telephone and e-mailing the photograph of a suspicious melanoma lesion can significantly reduce the time required for access to the consultation for the following patients: (a) referred for a suspicious lesion of melanoma by the GP (b) and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision (true positives).
Expected results: The procedure should shorten the care pathway for patients with melanoma and decrease the proportion of patients who do not consult the dermatologist when they were referred ("non-observing patients").
This should facilitate the identification of thinner lesions. The benefit for the patient is then direct with a survival at 5 years higher.
In public health terms, it is expected a benefit as better optimization of resources. In a situation of shortage of professionals, access to the dermatologist should be optimized by optimizing emergency access for patients who require it.
Conditions: Patients at Risk for Melanoma
Intervention / Treatment:
OTHER: Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
Patients:
* Consulting a general practitioner participating in the study,
* Having a suspicious cutaneous lesion of melanoma according to the MG,
* Referred to a dermatologist who agreed to participate in the study,
* > = 18 years, with written informed consent,
* Affiliated to a social security scheme
Exclusion Criteria:
Patients:
* Consulting a general practitioner who does not participate in the study,
* Having no suspect melanoma lesion according to MG,
* Referred to the dermatologist for symptoms or pathologies unrelated to a suspicion of melanoma
* Wishing to consult a dermatologist who refused to participate in the study,
* Refusing the transmission by mail of 2 anonymised photos,
* <18 years, or with no written informed consent.
* Major under tutelage, under curatorship
|
NCT_ID
NCT03137511
|
Study_NameOptimizing Access to Care Through New Technologies: a Randomized Study Evaluating the Impact of Telephone Contact and the Sending by the General Practitioner of Suspicious Lesions Melanoma Photographs Taken With a Smartphone, on the Time Limit to the Consultation With a Dermatologist
| 19,541 |
Study Objectives
The aim of this study is to determine whether selenium supplementation leads to changes in selenium levels and gene expression profiles in prostate tissue.
Conditions: Prostatic Neoplasms, Prostate Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: Selenium
Location: Netherlands
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* male
* biopsy proven prostate cancer
* scheduled for radical prostatectomy
Exclusion Criteria:
* liver diseases (e.g. hepatitis)
* kidney diseases
* inflammatory bowel diseases
* use of dietary supplements containing selenium
* adjuvant therapy for prostate cancer (e.g. hormonal therapy, HIFU)
* previously or concurrent diagnosed with cancer, other than prostate cancer
|
NCT_ID
NCT00446901
|
Study_NameSelenium and Prostate Cancer: Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression
| 9,914 |
Study Objectives
This is a multi-center, open-label Phase 0 substudy designed to study the localized pharmacodynamics (PD) of TAK-676 alone or in combination with Carboplatin, 5-FU, or Paclitaxel within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients diagnosed with Head and Neck Squamous Cell Carcinoma presenting with a surface accessible solid tumor for which there is a scheduled surgical intervention. This substudy is a cohort of the PBI-MST-01 Master Protocol.
Conditions: Head and Neck Squamous Cell Carcinoma
Intervention / Treatment:
DRUG: TAK-676, DRUG: Carboplatin, DRUG: 5-FU, DRUG: Paclitaxel, COMBINATION_PRODUCT: TAK-676 + Carboplatin, COMBINATION_PRODUCT: Carboplatin + Paclitaxel, COMBINATION_PRODUCT: Carboplatin + 5-FU, COMBINATION_PRODUCT: TAK-676 + Carboplatin + 5-FU, COMBINATION_PRODUCT: TAK-676 + Carboplatin + Paclitaxel
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: BASIC_SCIENCE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Ability and willingness to comply with the study's visit and assessment schedule.
* Male or female >= 18 years at Visit 1 (Screening).
* Pathologic diagnosis of Head and Neck Squamous Cell Carcinoma (HNSCC).
* Ability and willingness to provide written informed consent. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
* At least one lesion (primary tumor, recurrent tumor, or effaced metastatic lymph node) >= 2 cm in the shortest diameter that is surface accessible for CIVO injection that may be guided by ultrasound if appropriate and for which there is a planned surgical intervention. Treatment plan may include adjuvant radiation or chemotherapy, and patients should have no medical contraindication to surgery.
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 <= age <= 2.
* Female patients who:
* Are postmenopausal for at least one year before the screening visit, OR
* Are surgically sterile, OR
* Are of childbearing potential who agree to practice a highly effective method of contraception and one additional effective (barrier) method at the same time (see examples below) from the time of signing the informed consent form (ICF) through four months after the tumor injection procedure OR agree to completely abstain from heterosexual intercourse.
Highly effective methods:
* Intrauterine device (IUD)
* Hormonal (birth control pills/oral contraceptives, injectable contraceptives, contraceptive patches, or contraceptive implants
Other effective methods (barrier methods):
* Latex condom
* Diaphragm with spermicide; Cervical cap; Sponge
* Agree to refrain from donating ova during study participation and up to four months after the tumor injection procedure.
Male patients, even if surgically sterile (i.e., status post-vasectomy), who:
* Agree to practice effective barrier contraception from the time of signing the ICF through four months after the tumor injection procedure OR agree to completely abstain from heterosexual intercourse.
* Agree to refrain from donating sperm during study participation and up to four months after the tumor injection procedure.
Exclusion Criteria:
* Tumors or effaced nodes that are anticipated by the Investigator to lack a sufficient volume of viable tumor tissue (based on available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports) for CIVO injection due to size, location, necrosis, cysts, excessive stroma, or fibrosis.
* Patients who have received neoadjuvant therapy associated with the surgical intervention described in Inclusion Criterion #5.
* Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient.
* Female patients who are:
* Both lactating and breastfeeding, OR
* Have a positive β-human chorionic gonadotropin (hCG) pregnancy test at screening verified by the Investigator.
* Any uncontrolled intercurrent illness, condition, serious medical or psychiatric illness, or circumstance that, in the opinion of the Investigator, could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.
* Patients with a history of concurrent second cancers requiring active, ongoing systemic treatment.
* Patients with active autoimmune diseases requiring treatment or a known history of uncontrolled autoimmune disorders.
* Patients with known HIV/AIDS with uncontrolled viral load and cluster of differentiation 4 (CD4) less than 200, a known history of other relevant congenital or acquired immunodeficiencies, or known chronic hepatitis B/C.
* Patients that have received a live vaccine within 4 weeks of the baseline/screening visit.
* Use of any of the following <= 2 weeks prior to CIVO injection:
1. Chronic systemic immunosuppressive therapy or corticosteroids. Intranasal, inhaled, topical, or local corticosteroid injections (e.g., intra-articular injection), or steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) are exceptions to this criterion.
2. Biological response modifiers for treatment of active autoimmune disease.
3. Hematopoietic growth factors.
* Patients with prior treatment with other stimulator of interferon genes (STING) agonist/antagonist and toll-like receptor (TLR) agonists, or cell therapies within 2 months of the baseline/screening visit.
* Patients receiving concurrent systemic therapy (e.g., chemotherapy, targeted agent, or immunotherapy, etc.) or radiation therapy 4 weeks prior to screening through the planned surgical intervention.
|
NCT_ID
NCT06062602
|
Study_NamePBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC
| 16,198 |
Study Objectives
Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with cachexia.
Conditions: Cancer Cachexia
Intervention / Treatment:
DRUG: RC-1291, DRUG: placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion Criteria:
* Community-dwelling patients greater than 18 years with incurable, histologically diagnosed cancer.
* Involuntary loss of body weight greater than 5% within the past 6 months
Exclusion Criteria:
* Presently hospitalized or in a nursing care facility.
* Inability to increase food intake from secondary causes.
* Liver disease
* If female-pregnant, breast-feeding or of childbearing potential.
|
NCT_ID
NCT00378131
|
Study_NamePlacebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
| 1,059 |
Study Objectives
This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.
Conditions: Solid Tumor
Intervention / Treatment:
DRUG: GX-I7, DRUG: Cyclophosphamide
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* Histological confirmation of solid tumor, for which no standard therapy exists or is available any longer.
* Aged >=19 years(Korean age).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy >=12 weeks.
* Adequate hematological and end organ function defined by the following
* laboratory results obtained within 14 days prior to Cycle 1 Day 1 (C1D1)
* Female subjects of childbearing potential (including a female who has undergone tubal ligation) requires a negative serum pregnancy test performed within 14 days prior to C1D1.
* Have an evaluable lesion(s) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Subjects to be enrolled in the Phase 2a stage must be able to provide pre-treatment tissue biopsy or archival tissue and must have a tumor lesion.
* Providing the signed informed consent form (ICF).
Exclusion Criteria:
* Unable to adhere to the study procedures and follow-up procedures.
* Pregnant or lactating subjects.
* Have alcoholic or other hepatitis, liver cirrhosis, or genetic liver disease.
* Have uncontrolled type 2 diabetes mellitus.
* Have history of a major surgery within 28 days prior to C1D1 or are anticipated to require a major surgery during the study.
* Have an evidence of severe or uncontrolled systemic disease, uncontrolled hypertension.
* Have received any other investigational or approved anticancer therapy within 3 weeks prior to C1D1.
* With a positive result of human immunodeficiency virus (HIV) infection.
|
NCT_ID
NCT03733587
|
Study_NameGX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
| 21,020 |
Study Objectives
This phase I/II trial studies the best dose and side effects of mogamulizumab in combination with pembrolizumab and to see how well they work in treating patients with diffuse large B cell lymphoma that have come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as mogamulizumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Conditions: Recurrent Diffuse Large B-Cell Lymphoma, Recurrent High Grade B-Cell Lymphoma, Recurrent Transformed B-Cell Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory High Grade B-Cell Lymphoma, Refractory Transformed B-Cell Non-Hodgkin Lymphoma
Intervention / Treatment:
BIOLOGICAL: Mogamulizumab, BIOLOGICAL: Pembrolizumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patients must have histologically confirmed diffuse large B-cell lymphoma; all subtypes of diffuse large B-cell lymphoma are eligible, including high-grade B-cell lymphoma and diffuse large B-cell lymphoma (DLBCL) that has transformed from a prior indolent B-cell non-Hodgkin lymphoma
* Patients must have measurable disease per 2014 Lugano Classification Criteria which is defined as at least one nodal lesion measuring > 1.5 cm in greatest diameter or at least one extranodal lesion measuring > 1.0 cm in greatest diameter
* For phase 2: patients and received at least 2 prior lines of therapy and must have previously received, refused, or been deemed ineligible for autologous stem cell transplantation
* Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)
* Absolute neutrophil count >= 1,500/mcL (if neutropenia is related to bone marrow involvement with lymphoma, the absolute neutrophil count must be >= 1,000/mcL)
* Platelets >= 75,000/mcL (if thrombocytopenia is related to bone marrow involvement with lymphoma, the platelet count must be >= 50,000/mcL)
* Hemoglobin >= 9 g/dL (if anemia is related to bone marrow involvement with lymphoma, the hemoglobin must be >= 8 g/dL)
* Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN) or < 3 x the ULN for indirect bilirubin in patients with Gilbert's disease
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal
* Creatinine =< 1.5 x institutional upper limit of normal OR measured or calculated creatinine clearance if creatinine > 1.5 x ULN then creatinine clearance >= 40 mL/min/1.73 m^2 as calculated by Cockcroft and Gault equation
* Life expectancy of greater than 3 months
* The effects of MK-3475 (pembrolizumab) in combination with KW-0761 (mogamulizumab) 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, and 6 months after completion of MK-3475 (pembrolizumab) in combination with KW-0761 (mogamulizumab) administration; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of MK-3475 (pembrolizumab) in combination with KW-0761 (mogamulizumab) administration
* Submit adequate archival tissue specimen (25+ unstained slides or 2 tissue blocks) from a biopsy performed after progression of disease on most recent therapy OR subject is willing to undergo a new core or excisional biopsy to obtain evaluable tumor tissue sample for immunohistochemical assessment and sequencing for B2M loss; repeat samples may be required if adequate tissue is not provided, however, patients may still be considered for enrollment on a case by case basis following consultation with the principal investigator (PI)
* Ability to understand and the willingness to sign a written informed consent document
* Subjects with prior history of chemotherapy-induced or radiation-induced pulmonary toxicity require confirmation of diffuse capacity of the lung for carbon monoxide (DLCO) over 60% (adjusted for hemoglobin) by a pulmonary function test prior to study enrollment
Exclusion Criteria:
* Patients who have had previous systemic anti-cancer therapy within 3 weeks of registration or those who have not recovered from adverse events due to agents administered previously
* Note: Patients are considered enrolled on the study after protocol registration and not after signing consent
* Patients who are receiving any other concurrent investigational agents
* Patient is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment; the use of physiologic doses of corticosteroids (e.g. prednisone =< 20 mg/d) may be approved after consultation with the study PI; topical or inhaled corticosteroids are allowed
* Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer
* Patients with active cerebral or meningeal involvement by lymphoma should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound evaluation of neurologic and other adverse events
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-3475 (pembrolizumab) or KW-0761 (mogamulizumab)
* Subject with active autoimmune disease; subjects with vitiligo, eczema, alopecia, type I diabetes mellitus, psoriasis not requiring systemic treatment, or endocrine deficiencies (such as hypothyroidism) managed with replacement hormones, including physiologic corticosteroid replacement therapy are eligible
* Has a history or currently active (non-infectious) pneumonitis that required steroids unless prior history of chemotherapy or radiotherapy induced pneumonitis meeting the eligibility criteria
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Prior allogeneic stem cell transplant (SCT)
* Patients who are planning to receive allogeneic SCT in the near future as preliminary reports suggest added toxicity in patients undergoing allogeneic stem cell transplantation after having received mogamulizumab
* Autologous SCT =< 90 days prior to first dose of study drug
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease or active, non-infectious pneumonitis, 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 MK-3475 (pembrolizumab) is an agent 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 MK-3475 (pembrolizumab), breastfeeding should be discontinued if the mother is treated with MK-3475 (pembrolizumab); these potential risks may also apply to KW-0761 (mogamulizumab)
* MK-3475 (pembrolizumab) and KW-0761 (mogamulizumab) may have adverse effects on a fetus in utero; furthermore, it is not known if MK-3475 (pembrolizumab) or KW-0761 (mogamulizumab) has transient adverse effects on the composition of sperm; patients are excluded from this study if pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of trial treatment
* Patients with human immunodeficiency virus (HIV) are excluded if they have a detectable viral load, are not on a stable antiretroviral regimen, have a decreased CD4+ T-cell count (< 500), or require prophylactic antibiotics for the prevention of opportunistic infections
* Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection
* Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority
* Has a known history of active tuberculosis (TB)
* Patients with significant cardiac disease (e.g., New York Heart Association [NYHA] class III-IV congestive heart failure, unstable angina, recent myocardial infarction within the last 6 months, etc.)
|
NCT_ID
NCT03309878
|
Study_NameMogamulizumab and Pembrolizumab in Treating Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma
| 19,626 |
Study Objectives
This phase I trial studies how well \[18F\]DASA-23 and positron emission tomography (PET) scan work in evaluating pyruvate kinase M2 (PKM2) expression in patients with intracranial tumors or recurrent glioblastoma and healthy volunteers. PKM2 regulates brain tumor metabolism, a key factor in glioblastoma growth. \[18F\]DASA-23 is a radioactive substance with the ability to monitor PKM2 activity. A PET scan is a procedure in which a small amount of a radioactive substance, such as \[18F\]DASA-23, is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the substance is used. Tumor cells usually pick up more of these radioactive substances, allowing them to be found. Giving \[18F\]DASA-23 with a PET scan may help doctors evaluate PKM2 expression in healthy volunteers and in participants with intracranial tumors or recurrent glioblastoma.
Conditions: Healthy Subject, Intracranial Neoplasm, Glioblastoma
Intervention / Treatment:
DRUG: Fluorine F 18 DASA-23, PROCEDURE: Positron Emission Tomography
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
Age >=18 years.
* Adequate organ function (obtained within 14 days prior to PET scan [Part 1, Part 2, and Part 3 ONLY] or within 28 days prior to PET scan [Part 4 ONLY]) as evidenced by:
* ANC >= 1.5 X 10^9/L w/o myeloid growth factor support for 7 d preceding lab assessment
* Hgb >= 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb is corrected to >= 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan
* Platelet count >= 100 X 10^9/L w/o blood transfusions for 7 d preceding lab assessment
* Bilirubin <= 1.5 X ULN except for pts w/ documented history of Gilbert's disease
* ALT and AST <= 2.5 X ULN
* Alkaline phosphatase (AP) <= 3 X ULN
* Women of childbearing potential (WCBP): negative serum pregnancy test
3. Ability to stand up and climb two steps with minimal assistance.
4. Ability to understand and the willingness to sign a written informed consent document.
5. (Part 2, intracranial tumor patients ONLY) (a) Radiographical or pathological evidence of newly-diagnosed intracranial tumor that is status-pre surgical resection, or (b) Radiographical or pathological evidence of progressive/recurrent intracranial tumor, (c) Question of pseudoprogression vs. true progression on most recent standard-of-care brain MRI, or (d) Evidence on the most recent standard-of-care brain MRI scan of intracranial metastasis/metastases in a patient with known extracranial primary cancer.
6. (Part 3, GBM patients ONLY) Any patient with at least a 1cm3 contrast-enhancing lesion suspicious for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma) on a standard-of-care (SOC) brain MRI scan. If the patient undergoes a biopsy or resection for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma) then the remaining contrast-enhancing lesion is at least 1cm3 in size on the post-operative scan.
7. (Part 3, GBM patients ONLY) Life expectancy of >= 6 months.
Exclusion Criteria:
* Known allergy to adhesive tapes or other skin adhesives used in medical care
* Subjects with the following co-morbid disease or incurrent illness:
1. With known cirrhosis diagnosed with Child-Pugh Class A or higher liver disease.
2. Severe/uncontrolled inter-current illness within the previous 28 days prior to PET scan
3. Patients who have implantable devices that are contra-indicated for MRI
4. Bleeding disorder
5. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation.
6. (Healthy volunteers ONLY - Part 1 and Part 4) prior or current malignancy
7. (Healthy volunteers ONLY - Part 1 and Part 4) known kidney disease
* Pregnant or nursing participants
* History of allergic reactions to gadolinium-based MRI contrast agent
* (Part 2, intracranial tumor patients ONLY) Other chemotherapy (besides what is being used to treat the intracranial tumor)
* (Part 3, GBM patients ONLY) Has already begun therapy, prior to the first of two [18F]DASA-23 PET/MRI scans.
|
NCT_ID
NCT03539731
|
Study_Name[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers
| 1,678 |
Study Objectives
* There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments.
* SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells. These proteins are active in cellular pathways that are important for development and growth of a variety of different cancers. The targets of SU011248 include the receptors for vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that nourish the cancer cells and death of the cancer cells themselves.
* SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma, gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer has not been studied to date.
* This study is directed at two populations of men with advanced prostate cancer:
1. Men with advanced prostate cancer who have a rising PSA despite hormone therapy, but have not yet received any chemotherapy.
2. Men with metastatic prostate cancer who have received prior chemotherapy (with a docetaxel-based regimen) and have increasing disease following chemotherapy.
* Men in this study will receive SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The goals of the study are:
1. to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and
2. to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Sunitinib
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:
* Signed informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
* Adenocarcinoma of the prostate
* Male subjects, 18 years or older
* Life expectancy of > 12 weeks
* Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedure to National Cancer Institute Common Toxicity Criteria Adverse Event (NCI CTCAE) grade <1
* Surgical or ongoing chemical castration
* Androgen-independent disease, defined as progressive disease despite surgical or ongoing chemical castration. See section 8.2.3 for definition of progressive disease.
* Eastern Cooperative Oncology Group performance status of 0, 1 or 2
* Adequate bone marrow reserve:
* Neutrophil count > 1,500/ul
* Platelet count > 75,000/ul
* Adequate hepatic function:
* Serum bilirubin < 1.5 x upper limit of normal
* Asparate aminotransferase and alanine aminotransferase < 2.5 x upper limit of normal
* Adequate renal function, with serum creatinine < 2 x upper limit of normal
* Prostate Specific Antigen (PSA) > 5.0 ng/mL, based on PSA Working Group Criteria
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
For Group A only:
· No prior treatment for prostate cancer with cytotoxic chemotherapy
For Group B only:
* Radiographic evidence of metastatic prostate cancer
* One prior docetaxel-based chemotherapy regimen, minimum of two cycles
* Disease progression during treatment with docetaxel, or within 60 days of receiving docetaxel
Exclusion Criteria:
* Small cell carcinoma of the prostate
* Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed within four weeks of entry.
* Any of the following within the prior 6 months: unstable angina, myocardial infarction, symptomatic congestive heart failure or cerebrovascular accident
* Receipt of any investigational anti-cancer agent within 4 weeks of the study
* NCI CTCAE grade 3 hemorrhage < 4 weeks of starting study treatment
* Uncontrolled hypertension
* Prolongation of the QTc interval to > 450 msec
* Other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
|
NCT_ID
NCT00299741
|
Study_NameStudy of SU11248 in Men With Advanced Prostate Cancer
| 6,374 |
Study Objectives
After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades. We have already finished a prospective trial about apatinib for advanced osteosarcoma(NCT02711007) and find it has a objective response rate of aproximately 45% with median progression-free survival around 5 months. Thus, the investigators explored apatinib activity together with anti-PD1 therapy in order to induce durable response in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy.
Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to pazopanib, but with a binding affinity 10 times to VEGFR-2 comparing with pazopanib or sorafenib.
SHR-1210 is a humanized anti-PD-1 monoclonal antibody.
Conditions: Progression-free Survival, Overall Survival, Clinical Benefit Rate, Toxicity
Intervention / Treatment:
DRUG: Apatinib, DRUG: SHR-1210
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* age more than or equal to 11 years;
* diagnosis confirmed histologically and reviewed centrally;
* prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high- dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
* having measurable lesion according to RECIST 1.1;
* Eastern Cooperative Oncology Group performance status 0 <= age <= 1 with a life expectancy >3 months;
* Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment)as determined by: Hemoglobin >= 9 g/dL; Absolute neutrophil count (ANC) >=1.5×109/L; Platelet count >= 75×109/L (for patients with advanced hepatocellular carcinoma), Platelet count >= 100×109/L (for patients with advanced gastric cancer); serum albumin >=2.8 g/dL; serum total bilirubin (TBIL)<=1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5×upper limit of normal(ULN), for subjects with liver metastases, ALT and AST<=5×ULN; Calculated creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault formula will be used to calculate CrCl).
* normal or controlled blood pressure;
* Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women.
* surgery and/or radiotherapy completion at least 1 month before enrollment.
* Joining the study voluntarily with good compliance.
Exclusion Criteria:
* Patients must not have had prior treatment with camrelizumab or any other PD-L1 or PD-1 antagonists.
* Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
* Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed.
* Known history of hypersensitivity to any components of the camrelizumab formulation, or other antibody formulation.
* Active central nervous system (CNS) metastases with clinical symptoms (including cerebral edema, steroid requirement, or progressive disease). Subjects with brain or meningeal metastases that were previously treated must be clinically stable (magnetic resonance imaging [MRI] at least 4 weeks apart do not show evidence of new or enlarging metastases) and have discontinued immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration.
* Patients with other malignant tumor (except cured skin basal cell carcinoma and cervical carcinoma).
* Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class > 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(LVEF) < 50%.
* Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.
* Coagulation abnormalities (PT>16s、APTT>43s、TT>21s、Fbg<2g/L), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
* Active infection or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled).
* Previous experience abdomen fistula, gastrointestinal perforation, or abdominal abscess within 4weeks.
* Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc.
* History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or active hepatitis (transaminase does not meet the inclusion, hepatitis B virus (HBV) DNA >=10⁴ /ml or hepatitis C virus (HCV) RNA>=103 /ml or higher); Chronic hepatitis B virus carriers who HBV DNA<2000 IU/ml(<104/ml), must receive anti-viral treatment throughout the study.
* Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.
|
NCT_ID
NCT03359018
|
Study_NameApatinib Plus Anti-PD1 Therapy for Advanced Osteosarcoma
| 7,574 |
Study Objectives
This study is being done to see whether Avmacol®, a dietary supplement made from broccoli sprout and seed extract powder, induces changes in inner cheek cells that may be protective against environmental toxins such as tobacco.
There are three main goals of the study:
1. To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair damage from environmental toxins;
2. to learn how the body metabolizes Avmacol®, by measuring its byproducts in the participant's urine and blood;
3. to learn whether the immune system can be stimulated by Avmacol®, by studying the natural killer cells and T cells in the participant's blood.
Conditions: HNSCC, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Tobacco-Related Carcinoma, Carcinoma in Situ, Dysplasia, Hyperplasia, Premalignant Lesion
Intervention / Treatment:
DRUG: Avmacol®
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
|
Inclusion Criteria:
* Patients must have completed curative-intent therapy (including surgery, radiation, and/or chemotherapy) for a first tobacco-related oral premalignant lesion (OPL) or HNSCC of any stage (eligible lesions include high grade dysplasia; carcinoma in situ; or stage I-IVa HNSCC).
* Primary site may include oral cavity, pharynx, or larynx. Oropharynx primaries must be human papillomavirus (HPV) negative as defined by routine p16 IHC at the local site.
* Patients may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy).
* Patients may have untreated OPLs (i.e., hyperplasia, dysplasia, carcinoma in situ) at the time of study entry, provided the index OPL or HNSCC was definitively treated.
* Patients must have a Karnofsky Performance Status of 80% or higher or an Eastern Cooperative Oncology Group (ECOG) of 0 <= age <= 1
* Current and former tobacco users are eligible.
* Able to perform written, informed consent.
* Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 Days prior to the first study intervention.
* WCBP 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 she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.
Exclusion Criteria:
* Patient has a history of another malignancy within 2 years prior to starting study treatment, except for excised and cured carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T1 <= age <= 2, N0, M0 differentiated thyroid carcinoma either resected or under active surveillance; superficial bladder cancer; T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection, or status post external beam radiation or brachytherapy with normal PSA since radiation.
* Primary oropharyngeal HNSCC which is HPV (+) as defined by p16 immunohistochemistry.
* Participants with acute intercurrent illness or those who had major surgery within the preceding 4 weeks unless they have fully recovered.
* Participants who have a positive pregnancy test, are pregnant, or breast feeding.
* Patients who are not practicing adequate contraception are ineligible if they are of child bearing potential.
* Patients currently using anti-neoplastic or anti-tumor agents, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy.
* Chronic anticoagulation with warfarin. Patients on low molecular weight heparin or fondaparinux may be enrolled.
* Use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4
* Chronic use of steroids at immunosuppressive doses.
* History of severe food intolerance to broccoli.
|
NCT_ID
NCT03182959
|
Study_NameBroccoli Sprout Extract in Preventing Recurrence in Patients With Tobacco-Related Head and Neck Squamous Cell Cancer
| 14,820 |
Study Objectives
To evaluate the safety and tolerability of AMG 404, a monoclonal antibody that binds to PD-1 and inhibits its engagement with ligands, in patients with advanced solid tumors.
Conditions: Advanced Solid Tumors
Intervention / Treatment:
DRUG: AMG 404
Location: Poland, United States, Brazil, Australia, Spain, Singapore, United Kingdom, Taiwan, Japan, Belgium, Canada, Turkey, Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* Subject has provided informed consent prior to initiation of any study specific activities/procedures.
* Age greater than or equal to 18 years at the time of signing informed consent.
* Life expectancy of greater than 3 months, in the opinion of the investigator
* Subject must have histologically or cytologically confirmed metastatic or locally advanced solid tumors not amenable to curative treatment with surgery or radiation.
* Cohort 7: participant must have one of the following tumor types: melanoma, small cell lung cancer, NSCLC (PD-L1 positive), head and neck squamous cell cancer (PD-L1 positive), urothelial (PD-L1 positive), gastric or GEJ adenocarcinoma (PD-L1 positive), esophageal (squamous, PD-L1 positive), cervical (PD-L1 positive), hepatocellular carcinoma, merkel cell carcinoma, squamous cell carcinoma of the skin, renal cell carcinoma (clear cell) subtypes of sarcoma (undifferentiated pleiomorphic / malignant fibrous histiocytoma, poorly differentiated and/or dedifferentiated liposarcoma, alveolar soft tissue sarcoma, angiosarcoma), thymic carcinoma, nasopharyngeal carcinoma (EBV positive), mesothelioma
* Cohort 8: participant must be MSI-H or MMR-deficient
* Cohort 9: participant must have NSCLC, PD-L1 positive, TPS >= 50%; not have EGFR or ALK or ROS1 genomic tumor aberrations and may not have received prior systemic treatment for the advanced disease (prior neoadjuvant, adjuvant, or concurrent chemoradiation is allowed).
* At least 1 measurable as defined by modified RECIST 1.1 which has not undergone biopsy within 3 months of the screening scan. This lesion cannot be biopsied at any time during the study. Note: if there is only one lesion available for biopsy and radiographic assessment, it may be permitted to be biopsied after discussion with sponsor.
* Subjects 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 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 are deemed irreversible, 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.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2.
* Hematologic function, as follows without growth factor support within 2 weeks prior to study day 1: Absolute neutrophil count (ANC) greater than or equal to 1.0 x 10E9/L; Platelet count greater than or equal to 75 x 10E9/L; Hemoglobin greater than or equal to 9 g/dL (90 g/L).
* Adequate renal laboratory assessments, as follows: Estimated glomerular filtration rate based on MDRD (Modification of Diet in Renal Disease) calculation . 60 ml/min/1.73 m^2 for Cohorts 1, 2, and 4 Estimated glomerular filtration rate based on MDRD (Modification of Diet in Renal Disease) calculation >= 45 ml/min/1.73 m^2 for Cohorts 3, 6, 7, 8 and 9.
* Hepatic function, as follows: Total bilirubin less than or equal to 1.5 x ULN or less than or equal to 3 x ULN for subjects with liver metastasis; AST less than or equal to 3 x ULN or less than or equal to' 5 x ULN for subjects with liver metastasis; ALT less than or equal to 3 x ULN or less than or equal to 5 x ULN for subjects with liver metastasis; Alkaline phosphatase less than or equal to 2.5 x ULN or less than or equal to 5 x ULN for subjects with liver metastasis (Note: elevated alkaline phosphatase is acceptable if it is due to non-hepatic associated pathology [eg, bone disease]).
* Subjects enrolled to Cohorts 7 <= age <= 9 must submit tumor tissue sample. Fresh tumor biopsies may be performed if subject has a readily accessible tumor lesion and who consent to the biopsies. If fresh biopsies cannot be obtained, archival tumor samples are acceptable. Prior to enrollment it is required to determine that there is enough tumor tissue available to be sent to the central laboratory: Cohorts 7 and 9: Archival tissue collected up to 12 months prior to screening date is permitted. Biopsies collected between 12 <= age <= 18 months prior to screening are allowed upon discussion with the medical monitor. Subjects with EBV associated nasopharyngeal carcinoma may submit biopsy with EBV test results from within 36 months prior to screening; Cohort 8: Archival tissue with MSI-high/dMMR test results collected up to 36 months prior to screening is permitted.
Exclusion Criteria:
* Disease Related. Primary brain tumor, untreated or symptomatic brain metastases and leptomeningeal disease (exception: benign asymptomatic tumors are permitted).
* 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 greater than or equal to 2 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. Other malignancies which do not require systemic therapy, may be considered upon discussion with the medical monitor.
* History of solid organ transplantation.
* Major surgery within 28 days of study day 1.
* Prior/Concomitant Therapy: Prior treatment with anti-programmed death 1 (PD-1), anti-PD-L1, CTLA-4 or other checkpoint inhibitor drugs
* Anti-tumor therapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 21 days prior to study day 1. Note: Palliative radiotherapy is permitted.
* 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 greater than 10 mg prednisone daily or equivalent. Corticosteroids with no or minimal systemic effect (such as topical or inhalation) are permitted. Note: Corticosteroids > 10 mg prednisone used for management of contrast allergy for study scans is allowed.
* 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).
* Diagnostic Assessments: Evidence of interstitial lung disease or active, 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 for Human Immunodeficiency Virus (HIV).
* Has known active Hepatitis B (eg, hepatitis B antigen [HBsAg] reactive) or Hepatitis C (eg, HCV RNA [qualitative] is detected).
* Subject currently has an active infection requiring systemic therapy.
* Active or history of any autoimmune disease or immunodeficiencies. Subjects with Type I diabetes, 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 greater than class II), unstable angina, or cardiac arrhythmia requiring antiarrhythmic 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 non-invasive intervention AND there is agreement to allow by both the investigator and the Amgen Medical Monitor.
* Other Exclusions: Males and females of reproductive potential who are unwilling to practice highly effective methods of birth control while on study through 6 months (females) and 8 months (males) after receiving the last dose of AMG 404.
|
NCT_ID
NCT03853109
|
Study_NameAMG 404 in Patients With Advanced Solid Tumors
| 18,141 |
Study Objectives
A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and overall survival. The pharmacokinetic profile and the safety profile are also evaluated.
Conditions: Gastric Cancer
Intervention / Treatment:
DRUG: ARQ 197
Location: Korea, Republic of, Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Japanese or Korean with voluntary written informed consent for study participation
* A histologically or cytologically confirmed advanced/recurrent gastric cancer
* One or two prior chemotherapy regimens for advanced/recurrent gastric cancer
* At least one measurable lesion
* ECOG performance status of 0 or 1
* Life expectancy >=3 months
Exclusion Criteria:
* Surgery for cancer within 4 weeks prior to the first dose of ARQ 197
* Confirmed other tumors than gastric cancer within 5 years prior to the first dose of ARQ 197
* Anticancer chemotherapy, hormone therapy, radiotherapy or immunotherapy within 2 weeks prior to the first dose of ARQ 197
* Positive for HIV antibody
* Known symptomatic brain metastasis
* Gastrointestinal disorders that could interfere with the absorption of ARQ 197 or operation history for gastrointestinal disorders
* Uncontrolled concomitant disease
* Patients who wish to have a child and who would not agree to use contraceptive measures
* Pregnant or lactating
|
NCT_ID
NCT01152645
|
Study_NameStudy of ARQ 197 Monotherapy
| 22,403 |
Study Objectives
The purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent prostate cancer (APIC).
Conditions: Prostate Cancer
Intervention / Treatment:
BIOLOGICAL: IMC-A12, DRUG: Mitoxantrone, DRUG: Prednisone, BIOLOGICAL: IMC-1121B (ramucirumab)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* The participant has histologically-confirmed adenocarcinoma of the prostate
* The participant has radiographic evidence of metastatic prostate cancer (stage M1 or D2)
* The participant has prostate cancer unresponsive or refractory to hormone therapy (androgen-independent)
* The participant has had disease progression (clinical or radiographic) while receiving docetaxel, or within 120 days of receiving docetaxel-based chemotherapy and in the opinion of the investigator is unlikely to derive significant benefit from additional docetaxel-based therapy, or was intolerant to therapy with this agent
* The participant must have evidence of progressive disease defined as at least one of the following;
1. Progressive measurable disease: using conventional solid tumor criteria
2. Bone scan progression: at least two new lesions on bone scan
3. Increasing PSA: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2
* The participant has a PSA >= 2 ng/mL
* The participant has prior surgical or medical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment
* The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 <= age <= 2
* The participant has adequate hematologic function (absolute neutrophil count [ANC]>=1500/uL, hemoglobin >=9 g/dL, and platelets >=100,000/uL)
* The participant has adequate hepatic function (bilirubin <= 1.5 times the upper limit of normal (ULN), Aspartate Transaminase (AST) and Alanine Transaminase (ALT) <= 3 times the ULN, or <= 5 times the ULN if liver metastases are present)
* The participant has adequate renal function (creatinine <= 1.5 x ULN or calculated creatinine clearance > 40 mL/min)
* The participant's urinary protein is <= 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates >= 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
* The participant has adequate coagulation function (an international normalized ratio [INR] <= 1.5 and a Partial Thromboplastin Time [PTT] <= 5 seconds above the ULN [unless on oral anticoagulant therapy]). Participants receiving full-dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (and if on warfarin have a therapeutic INR between 2 and 3)
* The participant has a fasting serum glucose level of < 160 mg/dL, or below the ULN
Exclusion Criteria:
* The participant has received more than one prior cytotoxic chemotherapy regimen for metastatic disease. (Participants who have had a treatment break followed by a second docetaxel-based regimen with subsequent disease progression are eligible.)
* The participant has received prior therapy with mitoxantrone for advanced prostate cancer (prior adjuvant therapy with mitoxantrone is permitted)
* The participant has a history of symptomatic congestive heart failure or has a pre-study echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) that is >= 10% below the LLN
* The participant has received radiotherapy <= 21 days prior to first dose of IMC-A12 or Ramucirumab
* The participant is receiving corticosteroids (dexamethasone, prednisone, or others) at a dose > 5 mg prednisone orally (PO) two times per day (BID) or equivalent. Participants receiving corticosteroids at higher doses may be eligible if their corticosteroid therapy is tapered to study levels (prednisone 5 mg PO BID) prior to first dose of study medication, without concomitant clinical deterioration
* The participant has known or suspected brain or leptomeningeal metastases
* The participant has uncontrolled or poorly controlled hypertension
* The participant has poorly controlled diabetes mellitus. Inclusion Criteria:
* The participant has histologically-confirmed adenocarcinoma of the prostate
* The participant has radiographic evidence of metastatic prostate cancer (stage M1 or D2)
* The participant has prostate cancer unresponsive or refractory to hormone therapy (androgen-independent)
* The participant has had disease progression (clinical or radiographic) while receiving docetaxel, or within 120 days of receiving docetaxel-based chemotherapy and in the opinion of the investigator is unlikely to derive significant benefit from additional docetaxel-based therapy, or was intolerant to therapy with this agent
* The participant must have evidence of progressive disease defined as at least one of the following;
1. Progressive measurable disease: using conventional solid tumor criteria
2. Bone scan progression: at least two new lesions on bone scan
3. Increasing PSA: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2
* The participant has a PSA >= 2 ng/mL
* The participant has prior surgical or medical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment
* The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 <= age <= 2
* The participant has adequate hematologic function (absolute neutrophil count [ANC]>=1500/uL, hemoglobin >=9 g/dL, and platelets >=100,000/uL)
* The participant has adequate hepatic function (bilirubin <= 1.5 times the upper limit of normal (ULN), aspartate transaminase [AST] and alanine transaminase [ALT]<= 3 times the ULN, or <= 5 times the ULN if liver metastases are present)
* The participant has adequate renal function (creatinine <= 1.5 x ULN or calculated creatinine clearance > 40 mL/min)
* The participant's urinary protein is <= 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates >= 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
* The participant has adequate coagulation function (an international normalized ratio [INR] <= 1.5 and a partial thromboplastin time [PTT] <= 5 seconds above the ULN [unless on oral anticoagulant therapy]). Participants receiving full-dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (and if on warfarin have a therapeutic INR between 2 and 3)
* The participant has a fasting serum glucose level of < 160 mg/dL, or below the ULN
Exclusion Criteria:
* The participant has received more than one prior cytotoxic chemotherapy regimen for metastatic disease. (Participants who have had a treatment break followed by a second docetaxel-based regimen with subsequent disease progression are eligible.)
* The participant has received prior therapy with mitoxantrone for advanced prostate cancer (prior adjuvant therapy with mitoxantrone is permitted)
* The participant has a history of symptomatic congestive heart failure or has a pre-study echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) that is >= 10% below the LLN
* The participant has received radiotherapy <= 21 days prior to first dose of IMC-A12 or Ramucirumab
* The participant is receiving corticosteroids (dexamethasone, prednisone, or others) at a dose > 5 mg prednisone orally (PO) two times per day (BID) or equivalent. Participants receiving corticosteroids at higher doses may be eligible if their corticosteroid therapy is tapered to study levels (prednisone 5 mg PO BID) prior to first dose of study medication, without concomitant clinical deterioration
* The participant has known or suspected brain or leptomeningeal metastases
* The participant has uncontrolled or poorly controlled hypertension
* The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes are allowed to participate, provided that their blood glucose is within normal range (fasting < 120 mg/dL or below ULN) and that they are on a stable dietary or therapeutic regimen for this condition
* The participant has a known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness with a history of diabetes are allowed to participate, provided that their blood glucose is within normal range (fasting < 120 mg/dL or below ULN) and that they are on a stable dietary or therapeutic regimen for this condition
* The participant has a known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
|
NCT_ID
NCT00683475
|
Study_NameA Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer
| 12,383 |
Study Objectives
The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
Conditions: Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Intervention / Treatment:
DRUG: Azacitidine, DRUG: Pevonedistat
Location: Israel, Germany, United States, Czechia, Spain, Italy, Ireland, Netherlands, Bulgaria, Belgium, Canada, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Male or female participants >= 18 years.
* Morphologically confirmed diagnosis of MDS or nonproliferative CMML (that is, with white blood cells [WBC] <20,000 per microliter [/mcL]) or low blast AML based on 1 of the following:
French American British (FAB) Classifications:
* Refractory anemia with excess blasts (RAEB) - defined as having 5% to 20% myeloblasts in the bone marrow.
* CMML with 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood.
OR
WHO Classifications:
* RAEB 1 - defined as having 5% to 9% myeloblasts in the bone marrow.
* RAEB 2 - defined as having 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood.
* CMML 2 - defined as having 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood.
* CMML 1 (Although CMML 1 is defined as having <10% myeloblasts in the bone marrow and/or <5% blasts in the blood, these participants may enroll only if bone marrow blasts >=5%.
* WHO defined AML with 20% to 30% myeloblasts in the bone marrow and <30% myeloblasts in peripheral blood who are deemed by the investigator to be appropriate for azacitidine based therapy.
* For MDS and CMML participants, prognostic risk category, based on the Revised International Prognostic Scoring System (IPSS R), of:
* Very high (>6 points),
* High (>4.5 to 6 points), or
* Intermediate (>3 to 4.5 points): a participant determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of >=5% bone marrow myeloblasts.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Clinical laboratory values within the following parameters (repeat within 3 days before the first dose of study drug if laboratory values used for randomization were obtained more than 3 days before the first dose of study drug):
* Albumin >2.7 g/dL.
* Total bilirubin <upper limit of normal (ULN) except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin <=1.5*ULN of the direct bilirubin.
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5*ULN.
* Creatinine clearance >=50 milliliter per minutes (mL/min).
* Hb >8 g/dL. Participants may be transfused to achieve this value. Elevated indirect bilirubin due to post transfusion hemolysis is allowed.
* For CMML participants: WBC count <20,000/mcL before administration of the first dose of study drug on Cycle 1 Day 1; participants must have been off hydroxyurea for at least 1 week prior to WBC count assessment.
* Ability to undergo the study required bone marrow sample collection procedures.
* Suitable venous access for the study required blood sampling (that is, including pharmacokinetic (PK) and biomarker sampling).
* Female participants who:
* Are postmenopausal for at least 1 year before the Screening visit , or
* Are surgically sterile, or
* If they are of childbearing potential, agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or
* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
Male participants, even if surgically sterilized (that is, status postvasectomy), who:
* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
* Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Exclusion Criteria:
* Previous treatment with decitabine or azacitidine or other hypomethylating agent.
* Acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone marrow, or by other accepted analysis.
* Eligible for allogenic stem cell transplantation.
* Participants with MDS, CMML, or low blast AML, whose only site of disease is extramedullary, example, the skin.
* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures or could limit participant expected survival to less than 6 months.
* Treatment with any anti leukemic/anti MDS therapies (example, lenalidomide, cytarabine, anthracyclines, purine analogs) or with any investigational products within 14 days before the first dose of any study drug.
* Known hypersensitivity to mannitol.
* Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
* Major surgery within 14 days before first dose or a scheduled surgery during study period; insertion of a venous access device (example, catheter, port) is not considered major surgery.
* Diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection.
* Life threatening illness unrelated to cancer.
* Prothrombin time (PT) or prolongation of the activated thromboplastin time (aPTT) >1.5 ULN or active uncontrolled coagulopathy or bleeding disorder.
* Known human immunodeficiency virus (HIV) seropositive.
* Known hepatitis B surface antigen seropositive, or known or suspected active hepatitis C infection. Note: Participants who have isolated positive hepatitis B core antibody (that is, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load.
* Known hepatic cirrhosis or severe pre-existing hepatic impairment.
* Known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association [NYHA] Class III or IV) and/or myocardial infarction within 6 months prior to first dose, or severe pulmonary hypertension. As an example, well controlled atrial fibrillation would not be an exclusion whereas uncontrolled atrial fibrillation would be an exclusion.
* Treatment with strong cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days before the first dose of study drug.
* Systemic antineoplastic therapy or radiotherapy for other malignant conditions within 12 months before the first dose of any study drug, except for hydroxyurea.
* Female participants who are lactating and breast feeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.
* Female participants who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s).
* Male participants who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s).
|
NCT_ID
NCT02610777
|
Study_NameAn Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)
| 21,500 |
Study Objectives
Early intervention in children and adolescents who experience delayed MTX-clearance and renal dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic metabolites to avoid life threatening complications.
Conditions: Acute Lymphoblastic Leukemia (ALL)
Intervention / Treatment:
DRUG: Glucarpidase
Location: Sweden, Iceland, Denmark, Norway, Finland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
Children and adolescents who experience delayed MTX-clearance and renal dysfunction during high-dose methotrexate treatment in NOPHO ALL-2008.
Exclusion Criteria:
Children and adolescents with earlier anaphylactic reaction to Glucarpidase. Pregnant patients.
|
NCT_ID
NCT01305655
|
Study_NameGlucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL
| 8,755 |
Study Objectives
This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended phase II dose (RP2D), by assessing the maximum tolerated dose (MTD), safety and preliminary efficacy of selinexor in adult patients with relapsed/refractory B-cell malignancies receiving either R-DHAOx (Group A) or R-GDP (Group B). This dose escalation phase will be followed by an exploratory expansion phase in the same population with 12 patients enrolled in each group, who will receive selinexor at the RP2D.
The "3+3" design will be applied for dose escalation. The escalation will be performed independently in two distinct groups:
* Group A : Oral selinexor + R-DHAOx for 3 cycles (3-week cycles)
* Group B: Oral selinexor + R-GDP for 3 cycles (3-week cycles)
The choice of the conventional immunotherapy regimen which will be administered to each patient, R-DHAOx (Group A) or R-GDP (Group B), is left at the investigator's decision before patient's inclusion. Different dose levels for selinexor administration will be examined sequentially in each group by the Dose Escalation Committee (DEC): 4 doses of selinexor per 3-week cycle at 20 mg flat (Dose Level -1, DL-1), 40 mg flat (DL1), 60 mg flat (DL2) or 80 mg flat (DL3) will be taken orally by the patient on D1, D3, D8 and D10 of each cycle (dosing weeks = week 1 and week 2 of each 3-week cycle). Dose escalation will begin at DL1 and will continue until the MTD is exceeded or until the highest dose level defined in the study (DL3) is reached.
Dose escalation to the next planned dose level will be decided by the DEC based on the number of DLTs observed during the DLT assessment period.
The dose escalation phase will be followed by an exploratory expansion phase in the same two groups (Groups A and B), depending on the decision of the Independent Data Monitoring Committee (IDMC) after review of safety data at the end of dose escalation part.
Patients enrolled in the expansion phase will receive selinexor at the RP2D defined by the IDMC, together with either of the conventional regimen R-DHAOx or R-GDP (left at the investigator's choice).
Conditions: B-cell Lymphoma
Intervention / Treatment:
DRUG: selinexor, DRUG: Rituximab, DRUG: Dexamethasone, DRUG: Oxaliplatin, DRUG: Cisplatin, DRUG: Cytarabine, DRUG: Gemcitabine
Location: Belgium, 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 any type of relapsed or refractory B-cell lymphoma
* Eligible to receive R-DHAOx or R-GDP regarding the investigator's opinion
* Who received prior therapy with at least one but no more than two lines therapies for B-Cell Lymphoma
* Patient must have measurable disease defined by at least one single node or tumor lesion > 1.5 cm
* Aged between 18 years and 70 years (included) on date of consent signature
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* With a life expectancy of >= 3 months
* Having signed a written informed consent
* Male patients (if sexually active with a woman of childbearing potential) must agree to use a reliable method of birth control during the study treatment and for at least 6 months after the last study drug administration. Male patients must agree to not donate sperm during the study treatment and for at least 6 months after the last study drug administration
* Female patients of childbearing potential must agree to use two reliable methods of birth control during study treatment and for 6 months after the last dose and have a negative serum human chorionic gonadotropin (hCG) pregnancy test within 3 days prior to C1D1. Reliable methods of contraception include intrauterine devices, hormonal contraceptives [contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release], abstinence or sterilization of the partner.
Exclusion Criteria:
* Previous treatment with selinexor
* Known central nervous system or meningeal involvement by lymphoma
* Contraindication to any drug contained in these regimen
* Subjects with known Human Immunodeficiency Virus (HIV) positivity
* Subjects with known active Hepatitis B (HB) infection (positive Ag HBs) or positive serology to hepatitis B (Ag HBs or antibody anti-HB c or positive DNA PCR) or active Hepatitis C (HCV) infection (patients with positive HCV serology are eligible only if PCR is negative for known HCV RNA)
* Subjects with any uncontrolled active systemic infection requiring intravenous (IV) antibiotics
* Any of the following laboratory abnormalities within 14 days prior to first administration (C1D1) of study treatment:
1. Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L)
2. Spontaneous (within 7 days of any platelet transfusion) platelet count < 100,000/mm3 (100 x 109/L) (75 x 109/L if due to lymphoma)
3. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5.0 x upper limit of normal (ULN)
4. Serum total bilirubin > 2x Upper Limit of Normal (ULN), or > 5x ULN if due to Gilbert syndrome or lymphoma involvement
* Creatinine clearance < 50 mL /min (for patients who will receive DHAOx) or < 70 mL/min (for GDP)
* Subjects with pre-existing >= Grade 2 neuropathy
* Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the subject has been free of the disease for >= 3 years
* Any life-threatening illness, serious active disease or co-morbid medical condition, laboratory abnormality, organ system dysfunction or psychiatric illness which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of selinexor, or put the study outcomes at undue risk, or that would prevent the subject from signing the informed consent form
* Pregnant or breastfeeding women
* Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy (administration of glucocorticoids should not exceed 1mg/kg/day in the 14 days prior to C1D1)
|
NCT_ID
NCT02741388
|
Study_NameA Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP
| 19,174 |
Study Objectives
The single arm clinical study is to evaluate the efficacy and safety of Tislelizumab combined with Bevacizumab and albumin paclitaxel in the treatment of advanced lung adenocarcinoma. All of the patients were received EGFR-TKI therapy for 1 line and disease progression. The primary endpoint is six months PFS and safety, the seconday endpoint is ORR and one-year OS rate.
Conditions: Lung Adenocarcinoma Stage IV
Intervention / Treatment:
DRUG: Tislelizumab
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* lung adenocarcinoma stage Ⅳ(according AJCC 8)
* received EGFR-TKI for 1 line and disease progression
* EGFR T790M negative
* ECOG PS 0 <= age <= 2
Exclusion Criteria:
* histology of mixed NSCLC with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma.
* have received checkpoint inhibitor.
* uncontrolled pleural effusion, pericardial effusion, or ascites after appropriate intervention
* any unstable systemic disease
* patients who were treated with systemic glucocorticoids (>10mg/ day prednisone therapeutic dose) or other immunosuppressive drugs within 14 days prior to the initial administration or during the study period
|
NCT_ID
NCT04310943
|
Study_NameEfficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma
| 17,247 |
Study Objectives
Forty eight PCOS patients were included . The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:
1. history of chronic anovulation defined as cycle length \> 35 days, or less than 9 cycles per year or amenorrhoea (cycle length \> 12wks),
2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels
3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm).
the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months. Blood samples were collected at the start of the study, before receiving metformin, where baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) , total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and 6 months respectively of metformin treatment , to asses its effect on serum levels of the previously mentioned hormonal parameters.
Conditions: Polycystic Ovarian Syndrome
Intervention / Treatment:
DRUG: Metformin
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Non pregnant PCOS patients .
* The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:
1. history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks),
2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels
3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2 <= age <= 10mm).
Exclusion Criteria:
* those with prior history of glucose intolerance,
* history of gestational diabetes,
* NIDDM patients,
* cushing's syndrome,
* thyroid dysfunction,
* hyperprolactinemia,
* congenital adrenal hyperplasia
* patients on prolonged corticosteroid course, or other medications that alter the hormonal or metabolic profile; including PCOS patients who were on OCPs or cyclic progestagens
|
NCT_ID
NCT02568488
|
Study_NameThe Effect of Metformin on Different Hormones in PCOS Patients
| 15,934 |
Study Objectives
A phase 2, multicenter, open-label, single arm clinical trial in adults with newly diagnosed aggressive high-risk DLBCL.
Conditions: High-risk Diffuse Large B-Cell Lymphoma
Intervention / Treatment:
DRUG: Blinatumomab, DRUG: Investigator's Choice Chemotherapy, DRUG: Dexamethasone
Location: Germany, United States, Spain, United Kingdom, Canada, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion criteria:
* Subject has provided informed consent prior to initiation of any study-specific activities/procedures
* Age >= 18 at time of informed consent
* Subject must have untreated histologically proven high-risk DLBCL defined by atleast one of the following:
* International Prognostic Index (IPI) for Diffuse Large B-cell Lymphoma 3 to 5 (representing high intermedidate - high ratings),
* Double-hit or higher or double protein expression
* Eastern Cooperative Oncology Group performance status <= 2.
* Subject meets the criteria per investigator's institution to receive standard of care (SOC) rituximab-chemotherapy (ie, R-CHOP [14 or 21] or R-DA-EPOCH or R-CHOEP) of 6 cycles. Subjects may be enrolled on study prior to cycle 1 or cycle 2 of SOC R-chemotherapy
* Adequate organ and bone marrow function determined within 14 days prior to enrollment defined as:
* Hematological: Absolute neutrophil count >=1*10^9/L; Platelet count >=75*10^9/L;Hemoglobin >=8g/dL
* Renal: Creatinine clearance >=50mL/min;
* Hepatic: Aspartate aminotransferase/Alanine aminotransferase <3*upper limit of normal (ULN); Total bilirubin <2*ULN (unless Gilbert's Disease or if liver involvement with lymphoma)
* Subject must have completed 6 cycles of SOC R-chemotherapy and achieved CR, PR or stable disease by PET/CT performed 3 weeks (± 3 days) after cycle 6 of SOC R-chemotherapy. Subjects with progressive disease (PD) are not eligible for treatment with blinatumomab and will end the study.
Exclusion Criteria:
* Clinically relevant central nervous system (CNS) pathology requiring treatment such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis
* Evidence of CNS involvement with DLBCL at disease evaluation obtained prior to starting blinatumomab
* Current autoimmune disease or history of autoimmune disease with potential of CNS involvement
* Subject has active infection requiring systemic therapy
* Prior anti-CD19 therapies
* Known infection with HIV or chronic infection with hepatitis B virus or hepatitis C virus
* History of other malignancy within the past 3 years with the following exceptions:
* 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 malignancy 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 non-invasive carcinoma or carcinoma in situ
* Subject has known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing.
* Subject 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 subject's and investigator's knowledge.
* History/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 subject safety or interfere with the study evaluation, procedures or completion.
* Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed while receiving blinatumomab and for an additional 48 hours after the last treatment dose of blinatumomab.
* Currently receiving treatment in another investigational device or drug study or less than 30 days since ending treatment on another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
|
NCT_ID
NCT03023878
|
Study_NameSafety and Efficacy of Blinatumomab in Adults With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma
| 17,868 |
Study Objectives
The ability of sildenafil to aid in the return of erections after nerve-sparing radical prostatectomy has been established. Patients who had either one or both neurovascular bundles spared demonstrated dramatically better responses to "as needed" sildenafil than those that did not, and a positive erectile response to sildenafil was only seen in patients in whom at least one NVB was spared. This study has been designed to determine if sildenafil taken nightly works better than sildenafil on as "as needed" basis for the return of erectile function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid return of erectile function after nerve-sparing laparoscopic radical prostatectomy.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Sildenafil
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: DOUBLE
|
Inclusion Criteria:
* Male sex
* Age < 65
* IIEF erectile function domain score > 26 (out of 30 points possible for this subscale)
* Steady sexual partner
* Untreated prostate cancer TNM stage < cT2bNxMx (cT1a, cT1b, cT1c, cT2a) and Gleason grade < 8.
* Willingness to participate in a clinical trial as manifested by informed consent
* Actually undergo nerve-sparing LRP surgery
Exclusion Criteria:
* Not fulfilling all of the criteria for entry above
* Any prior prostate cancer treatment (radiation, hormonal deprivation, chemotherapy)
* Contraindication to sildenafil (e.g. nitrates, hypersensitivity)
* Existing PDE5 inhibitor requirement for functional erection (e.g. for intercourse) preoperatively
* Obstructive sleep apnea
|
NCT_ID
NCT00511498
|
Study_NameEffect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy
| 22,361 |
Study Objectives
Primary:
* Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of lenvatinib administered in combination with dacarbazine.
* Phase II: To evaluate the safety and tolerability of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone.
Secondary:
-Phase II: To make a preliminary assessment of the efficacy of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone.
Conditions: Stage IV Melanoma
Intervention / Treatment:
DRUG: Lenvatinib, DRUG: Lenvatinib, DRUG: Dacarbazine
Location: Germany, United Kingdom, United States, Spain, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patients with histologically-confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer (AJCC)).
* No prior cytokine, chemotherapy, or targeted therapy for Stage IV melanoma.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Life expectancy greater than or equal to 3 months.
* At least 1 site of measurable disease by RECIST 1.1.
* Adequate hematologic, renal, liver, and coagulation system function as defined by laboratory values performed within 21 days prior to initiation of dosing.
* Blood pressure must be well-controlled (less than or equal to 140/90 mmHg at screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy.
Exclusion Criteria:
* Known central nervous system (CNS) lesions, except for asymptomatic, nonprogressive, treated brain metastases. Treatment for brain metastases must have been completed at least 4 weeks prior to Day 1 and may include whole brain radiotherapy (WBRT), radiosurgery [RS; Gamma Knife, linear accelerator (LINAC), or equivalent] or a combination as deemed appropriate by the treating physician. Dexamethasone must be discontinued at least 3 weeks prior to Day 1. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
* Lactate dehydrogenase greater than or equal to 2.0 x upper limit of normal (ULN).
* Subjects with proteinuria greater than 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with 24-hour urine protein greater than or equal to 1 g/24 hours will be ineligible.
* Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures.
* Other active malignancy.
* History of or known carcinomatous meningitis.
* History of or known ocular melanoma.
* Are currently receiving any other treatment for the tumor (including palliative radiotherapy) aside from control of symptoms.
* Received treatment in another clinical study within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to grade less than or equal to 1, except for alopecia.
* Received radiotherapy within the 30 days prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to grade less than or equal to 1, except for alopecia.
* Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within the 28 days prior to commencing study treatment. Minor surgery such as Portacath placement or skin biopsy is permitted if greater than or equal to 7 days have passed.
* History of bleeding diathesis or coagulopathy.
* Current use of anti-coagulants such as Vitamin K antagonists, unfractionated heparin, or low molecular weight heparin.
|
NCT_ID
NCT01133977
|
Study_NameE7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma
| 21,518 |
Study Objectives
No doubt that children facing surgical procedures are subjected to perioperative distressing, anxious and worrying periods. Several factors included; parental deprivation, anxiety, previously mismanaged experience and anticipating pain from the procedure itself weather diagnostic or curative. Anaesthetic goals should focus at alleviating these unfavorable events that may exacerbate the inevitable associated neurohormal stress response with its injurious effects on the course of the procedure. Moreover, it likely to extend beyond the surgical procedure predisposing these vulnerable group of patients to psychological trauma and chronic behavioral changes.
Bone marrow aspiration (BMA) is a frequent procedure that necessitate a meticulous anaesthetic plane that entails rapid non-traumatic induction together with adequate pain free maintenance and instant smooth recovery after a short time practice. Total intravenous anaesthesia (TIVA) had emerged as alternative anaesthetic technique to inhalational anaesthesia for conscious sedation in BMA cited by many authors.
Propofol a popular anaesthetic/ sedative with a rapid onset, short duration and smooth recovery of consciousness and psychomotor functions with no cumulation. However it is poorly analgesic, depresses respiration and there is a possibility of loss of muscle tone leading to airway obstruction .
Dexmedetomidine is a greatly active α2 adrenergic agonist with a valuable anaesthetic- analgesic saving effects. It augments sedation, hypnosis and preservation of muscle tone with negligible respiratory depression and hemodynamic derangements.
The purpose of the current study is to compare between effects of TIVA using propofol or dexmedetomedine versus sevoflurane for maintenance of anaesthesia in children undergoing bone marrow aspiration.
Conditions: Invasive Cancer, Pediatric Cancer
Intervention / Treatment:
DRUG: Sevoflurane, DRUG: Propofol infusion for maintance, DRUG: Dexmedetomidine
Location: Egypt
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE
|
Inclusion Criteria:
* patients aged 3 <= age <= 12 years.
* both sexes
* ASA physical status I and II
Exclusion Criteria:
* Patients with identified allergy to the study medications
* with recognized lipid or carbohydrate deranged metabolism
* cardiac dysrhythmias
* congenital heart diseases
* cardiomyopathy
* significant organ dysfunction.
|
NCT_ID
NCT05636566
|
Study_NameComparing TIVA Using Propofol or Dexmedetomidine Versus Sevoflurane During Anaesthesia of Children Undergoing Bone-Marrow Aspiration
| 206 |
Study Objectives
The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Conditions: Advanced Solid Tumors Cancer
Intervention / Treatment:
DRUG: ABBV-368, DRUG: Tilsotolimod, DRUG: Nab-paclitaxel, DRUG: ABBV-181
Location: Israel, Germany, United States, Spain, Netherlands, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* Participants should weigh at least 35 kg.
* Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of >= 3 months.
* Participant have >= 1 lesion accessible for intratumoral injection.
* Histologically or cytologically confirmed R/M HNSCC (of the following 4 subsites: oral cavity, oropharynx, larynx, and hypopharynx) who previously progressed either during or after <= 3 prior treatment regimens administered in the recurrent or metastatic setting.
* Must have received 1 immunotherapy regimen which included a PD-(L)1 inhibitor.
* Must have received platinum-based therapy, or be considered ineligible for platinum-based therapy by the investigator.
Exclusion Criteria:
* Uncontrolled metastases to the central nervous system (CNS).
* Participants with brain metastases are eligible provided that evidence of clinical and radiographic stable disease for at least 4 weeks after definitive therapy is given and participants have not used prohibited levels of steroids for at least 4 weeks prior to first dose of the study.
* Received prior treatment with OX40 or toll-like receptor (TLR) agonists (excluding topical agents).
|
NCT_ID
NCT04196283
|
Study_NameA Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
| 20,872 |
Study Objectives
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Conditions: Advanced Esophageal Cancer
Intervention / Treatment:
DRUG: SHR-1210, DRUG: Placebo, DRUG: paclitaxel, DRUG: cisplatin
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
* No previous systemic anti-tumor treatment;
* Subjects must have at least one measurable tumor lesion per RECIST 1.1;
* Tissue samples should be provided for biomarkers (such as PD-L1) analysis;
* ECOG: 0 <= age <= 1;
* Adequate organ and bone marrow function;
Exclusion Criteria:
* Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;
* Prior therapy as follow:
1. Anti-PD-1 or anti-PD-L1;
2. Any experimental drugs within 4 weeks of the first dose of study medication;
3. Received major operations or serious injuries within 4 weeks of the first dose of study medication;
4. Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
* Not recovered to <=CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
* Subjects with any active autoimmune disease or history of autoimmune disease;
* Pregnancy or breast feeding;
|
NCT_ID
NCT03691090
|
Study_NameStudy of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer
| 12,685 |
Study Objectives
This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate. This dose titration study is being conducted to support the statement that personalized titration of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient response.
Conditions: Primary Hypertension, Secondary Hypertension
Intervention / Treatment:
DRUG: lisinopril, ACE-inhibitor
Location: Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Parental consent must be granted
* Patient age: 1y - 18 y
* Documented diagnosis of hypertension as defined in the National Heart, Lung and Blood Institute (NHBLI) 4th report, 2004
* No reversible cause found on diagnostic work-up for hypertension
* Children older than 6y: 24h blood pressure monitoring confirms the diagnosis of hypertension
Exclusion Criteria:
* Pregnancy
* Sexually active girls can only be included in the trial if they use an adequate form of birth control; during and until 30 days after ending the trial
* Following abnormal laboratory values: Hyperkaliemia (serum potassium > 5.3mmol/L); Anemia (hemoglobin < 8g/dL); AST or ALT > 3 times the upper limit of reference range; Total bilirubin > 3 times the upper limit of reference range
* Abnormalities of the oral cavity that can influence intake of medication
* Known sensitivity to ACE-inhibitors
* Known lactose intolerance
* History of angioedema
* Unilateral or bilateral stenosis of the renal artery
* Diagnosis of heart failure (NYHA Class II-IV)
* History of coarctation of the aorta
* Current treatment with: other drugs influencing the renin-angiotensin-aldosterone system; lithium; potassium sparing diuretics; non-steroidal anti-inflammatory drugs; aspirin; oral antidiabetic medication
|
NCT_ID
NCT02184858
|
Study_NameDose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension
| 6,910 |
Study Objectives
Longer first line chemotherapy duration has recently been associated with a modest, but significant improvement in overall survival and a clinically meaningful and statistically significant improvement in progression-free survival, in metastatic breast cancer patients. Prolonging chemotherapy until disease progression, however, must be weighed against the detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the tolerability of prolonged chemotherapy administration strategy by studying alternative treatment schedules, while preserving and possibly improving treatment efficacy in this disease setting.
The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®), represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an attempt to reduce the toxicity associated with standard taxane administration (caused by the use of chemical solvents) while increasing antitumor efficacy.
The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged chemotherapy administration strategy. Each of three arms will be compared to a historical reference of seven-month median progression-free survival (PFS) based on the most recent trial with docetaxel as control arm to determine whether any of the three arms are worthy of further investigation.
Conditions: Metastatic Breastcancer
Intervention / Treatment:
DRUG: nab-Paclitaxel
Location: Slovenia, Spain, Italy, Ireland, Belgium, Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer.
* Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria.
* Female aged >= 18 years.
* Life expectancy > 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy.
* If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
* Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
* Normal hematologic status.
* Normal renal function.
* Normal liver function.
* Normal cardiac function.
* Women of childbearing potential: documented negative pregnancy test within 2 weeks prior to randomization, and acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug.
* Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
* Completed baseline Quality of Life Form.
* The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
* Availability of an formalin fixed paraffin embedded (FFPE) block from the primary tumor (breast lesion) for submission to central pathology review and for translational research.
* Written consent to pathology material submission, signed and dated by the patient and the Investigator prior to randomization.
Exclusion Criteria:
* Any prior chemotherapy for metastatic breast cancer.
* Presence of central nervous system (CNS) metastasis.
* Peripheral neuropathy grade 2 or higher (CTCAE version 4).
* Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
* Pregnant or lactating.
* Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
* Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
* Contraindications or known hypersensitivity to the study medication or excipients.
* The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
* Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.
|
NCT_ID
NCT01746225
|
Study_NameSchedules of Nab-Paclitaxel in Metastatic Breast Cancer
| 502 |
Study Objectives
A double-blind, placebo controlled study conducted at a single study site. Evaluating the role of systemic antihistamine therapy in the reduction of adverse effects associated with topical 5-aminolevulinic acid photodynamic therapy.
Conditions: Actinic Keratoses
Intervention / Treatment:
DRUG: Antihistamine Cetirizine Hydrochloride, OTHER: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Age > 18
* Subjects with 5 <= age <= 20 actinic keratosis of the face
* Patients undergoing photodynamic therapy (PDT) to the face for AK with 5-aminolevulinic acid (ALA) activated by blue light.
* Must be willing to give and sign a HIPPA form, photo consent and informed consent form.
* Must be willing to comply with study dosing and complete the entire course of the study.
* Female patients will be either of non-childbearing potential defined as:
1. Having no uterus
2. No menses for at least 12 months.
Or;
(WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
* Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
* Intrauterine coil
* Bilateral tubal ligation
* Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
* Abstinence (If practicing abstinence must agree to use barrier method described above (d) if becomes sexually active).
* Vasectomized partner g. Negative urine pregnancy test results Baseline prior to study entry (if applicable)
Exclusion Criteria:
* Presence of incompletely healed wound in treatment area
* Presence of known or suspected BCC or SCC in treatment area
* Previous PDT or treatment of the face with any topical cytotoxic or immunomodulatory agent for AKs within the past 6 months
* Co-existing potentially confounding skin condition within treatment area (e.g. eczema, psoriasis, XP, rosacea) at investigator's discretion
* Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
* Subjects with known photosensitivity or taking photosensitizing medications listed below:
1. Oral diabetes medicines
2. Griseofulvin
3. Thiazide diuretics
4. Sulfonylureas
5. Phenothiazines
6. Tetracycline's
7. St. John's Wort
* Use of oral/topical retinoids within 1 month of Baseline
* Subjects with a history of sensitivity to porphyrins
* Subjects with recently excessive exposure of the treatment area to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study
* Female subjects who are pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study
* Presence or evidence of any conditions that in the opinion of the investigator might impede the subject's ability to give consent or comply with protocol requirements.
* Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
* History of non-compliance with clinical research protocols
* Ablative laser resurfacing to on their face within 12 months
* Non-ablative laser or light procedures to their face within the past 3 months
* Microdermabrasion (light or medium skin peel) treatment on their face within the past 30 days
|
NCT_ID
NCT02451579
|
Study_NameA Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy
| 17,412 |
Study Objectives
A phase II trial to evaluate the efficacy and safety of combination bendamustine and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is hypothesized that the BR combination will produce at least a 70% overall response rate.
Conditions: Diffuse Large B-Cell Lymphoma
Intervention / Treatment:
DRUG: bendamustine, DRUG: rituximab
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 CD20-positive, diffuse large B-cell lymphoma
* Measurable disease with at least one bidimensional lymph node or tumor mass > 1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT
* Relapsed or refractory after at least one prior therapeutic treatment for diffuse large B-cell lymphoma. Relapsed is defined as patients who initially responded and then progressed. Refractory is defined as patients, whom in the judgment of the Investigator, received adequate prior treatment and did not respond during treatment or progressed within 60 days of last treatment. Relapse following an autologous stem cell transplant allowed.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 <= age <= 2
* Patient must understand and voluntarily sign IRB-approved informed consent
* Life expectancy >= three (3) months
* Age >= 18 years
* Laboratory parameters:
* Absolute neutrophil count >= 1,000 cells/mm(3)
* Platelet count >= 75,000 cells/mm(3)
* Hemoglobin >= 8 g/dL
* Creatinine <= 2.0 mg/dL or Creatinine Clearance >= 50 mL/min (calculated or 24-hr urine sample)
* AST/SGOT 2.0 x ULN (<= 5.0 x ULN if secondary to liver metastases)
* ALT/SGPT 2.0 x ULN (<= 5.0 x ULN if secondary to liver metastases)
* Total bilirubin <= 2.0 x ULN
Exclusion Criteria:
* Patients with active/symptomatic central nervous system (CNS) involvement based on clinical evaluation. Previously treated CNS involvement that has remained asymptomatic for >= 90 days allowed if no CNS involvement shown by lumbar puncture, PET, CT or MRI.
* Prior treatment with bendamustine
* Known sensitivity to bendamustine or any component of bendamustine
* Known anaphylaxis or immunoglobulin E (IgE) mediated hypersensitivity to murine proteins or sensitivity to rituximab or any component of rituximab
* Eligible for stem cell transplant (patients who refuse procedure will not be excluded)
* Prior allogeneic stem cell transplant within 6 months of Cycle 1, Day 1
* Major surgery, not related to debulking procedures, within 21 days of Cycle 1, Day 1. Patients undergoing debulking procedures and minor surgery are allowed after a recovery period, in the judgment of the Investigator.
* Chemotherapy, immunotherapy, or irradiation within 28 days of Cycle 1, Day 1 (within 6 weeks for nitrosoureas or mitomycin). Patients on high dose corticosteroids must have tapered to a stable dose equivalent to Prednisone <= 15 mg per day within 28 days of Cycle 1, Day 1.
* Prior radioimmunotherapy (i.e. Zevalin®) within 10 weeks of Cycle 1, Day 1
* Prior use of investigational anti-cancer agents within 28 days of Cycle 1, Day 1
* Unresolved toxicities >= grade 2 from previous therapy
* Pregnant or lactating females. Females of childbearing potential (FCBP) and non-vasectomized men must agree to use effective methods of birth control during and 28 days following treatment period. FCBP must have a negative pregnancy test.
* HIV-related lymphoma
* Known active HIV or HCV infection, or known seropositivity for HIV, or current or chronic HBV or HCV infection. HBV test required at screening or within 6 months of screening and must indicate negative result. Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B or resolved infection are not excluded (see HBV reactivation guidelines included in rituximab prescribing information).
* Concurrent active or history of other malignancies, except nonmelanoma skin cancer or carcinoma in situ of cervix or breast. Patients with previous malignancies are eligible provided they have been disease free for >= 1 year.
* Serious (grade 3 <= age <= 4), active, intercurrent infection requiring therapy, or deep seated or systemic mycotic infections
* Myocardial infarction within 6 months prior to registration or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities, in the judgment of the Investigator
* Thyroid disease in which thyroid function cannot be maintained within normal range, in the judgment of the Investigator
* Concurrent uncontrolled serious medical or psychiatric conditions likely to interfere with participation in this clinical study, in the judgment of the Investigator
|
NCT_ID
NCT00831597
|
Study_NameBendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
| 20,224 |
Study Objectives
The purpose of this study it to determine the safety and maximally tolerated dose (MTD) of cisplatin administered in the operating room and put into the chest and abdomen for one hour. We are also looking at the effects of heating the chemotherapy to a temperature of 42 degrees celsius.
Conditions: Pleural Mesothelioma, Malignant Pleural Mesothelioma
Intervention / Treatment:
DRUG: Cisplatin, DRUG: Sodium Thiosulfate
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:
* Histopathologic confirmation of malignant pleural mesothelioma
* Patients who are able to tolerate surgical cytoreduction but unable to undergo extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion
* 18 years or older
* Malignancy is confined to the affected hemithorax.
* Grossly normal cardiac function with an EKG showing no cardiomyopathy or acute changes
* Evidence of adequate renal and hepatic function
* Karnofsky performance status of 70% or greater
Exclusion Criteria:
* Extended disease outside the ipsilateral hemithorax as determined radiologically and intraoperatively
* Distant metastases
* Non-malignant systemic disease
* Active concomitant malignancy
* Psychiatric or addictive disorders which would preclude obtaining informed consent
* Prior treatment within the last 2 months, other than surgical resection for their current malignancy
|
NCT_ID
NCT00165555
|
Study_NamePleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma
| 13,773 |
Study Objectives
Primary Objective:To evaluate the efficacy and safety of TIP (paclitaxel + ifosfamide + cisplatin) combined with nimotuzumab \& triprilimab as neoadjuvant treatment in locally advanced penile cancer.
Conditions: Penile Cancer
Intervention / Treatment:
DRUG: Albumin-Bound Paclitaxel, DRUG: Ifosfamide, DRUG: Cisplatin, DRUG: Nimotuzumab, DRUG: Triprilimab
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Squamous cell carcinoma confirmed by histology or cytology;
* Clinical Stage is Locally advanced penile cancer (T4, any N stage; or any T stage, N3);
* No prior chemotherapy for newly diagnosed or relapsed patients;
* There is at least one measurable lesion according to the solid tumor efficacy evaluation standard RECIST1.1;
* the Eastern Cooperative Oncology Group (ECOG) scored 0 <= age <= 2;
* Blood marrow function: Hemoglobin(Hb) >= 80g/L; White blood cell count >= 3.0x10^9/L; Neutrophil count >= 1.5x10^9/L; Platelet count >= 100x10^9/L;
* Liver function: AST, ALT, ALP <= 2.5 ULN; Total bilirubin <= 1.5 ULN;
* Estimated survival >= 12 months;
* No prior serious disease history of systemic organ;
* The participant unterstand this study procedure and sign the informed consent.
Exclusion Criteria:
* Peripheral neuropathy degree >=2 (affecting patient's function);
* Previously received any other experimental drug treatment within 4 weeks before enrollment;
* Patients with other cancer at present, or have other malignent tumor history within past 5 years. Except for: (1) Cured skin non-malignant melanoma; (2) Curable tumor, including low-risk prostate cancer (T1a, Gleason score<6, PSA<0.5ng/ml), superficial bladder cancer and so on; (3) Other solid tumors have received radical treatment, and no recurrence or metastasis has been found at least 5 years;
* Other serious or poorly controlled concomitant diseases, including but not limited to: (1) Severe or acute attack disease history of cardiovascular, liver, respiratory, kidney, blood ,endocrine or neuropsychiatric system within 6 months; (2) Active infection history and needed antibiotic treatment within 2 weeks before enrollment; (3) Congestive heart failure (grade III-IV); (4) Unstable angina pectoris or myocardial infarction history within 6 months.
|
NCT_ID
NCT04475016
|
Study_NameTIP (Paclitaxel + Ifosfamide + Cisplatin) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer
| 8,110 |
Study Objectives
The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of the study is to determine the effect of IPI-504, in combination with docetaxel, verses placebo in, combination with docetaxel, on the growth of cancer
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: IPI 504 plus Docetaxel, DRUG: Placebo plus Docetaxel
Location: United States, Taiwan, Russian Federation, Romania, Korea, Republic of, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Patients must be >=18 years
* Voluntarily signed an informed consent
* Confirmed NSCLC and Stage IIIB or IV disease.
* At least a >=15 pack year smoking history and must have been an active smoker within 20 years of diagnosis.
* Must have archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
* Must have experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.
* Must have received no more than 2 prior chemotherapy regimens
* Measurable disease by RECIST 1.1 criteria.
* ECOG performance status of 0 or 1 (Refer to scale in Appendix 1).
* Women of child-bearing potential (WCBP), all sexually active male patients, and partners of patients must agree to use adequate methods of birth control.
Exclusion Criteria:
* Prior docetaxel, IPI-504 or other Hsp90 inhibitor treatment
* Known hypersensitivity to drugs formulated with polysorbate-80.
* Not recovered from any toxicities related to prior treatment
* Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer
* Inadequate hematologic function
* Inadequate hepatic function
* Inadequate renal function
* Symptomatic keratitis or keratoconjunctivitis.
* Uncontrolled systemic fungal, bacterial, viral or other infection
* Patients with clinically active brain metastases
* Patients with clinically stable brain metastases (previously treated or untreated) are eligible.
* Sinus bradycardia (resting heart rate <50 bpm).
* Significant cardiac disease
* Previous or current malignancies at other sites within the last 2 years
* Prior hepatic resections or hepatic-directed therapy
* Known HIV-positive patients receiving combination antiretroviral therapy.
* Women who are pregnant or lactating.
|
NCT_ID
NCT01362400
|
Study_NameA Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
| 14,948 |
Study Objectives
to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical high-risk HPV infections; to analyze the HPV type infections and clinical negative conversion.
285 patients with positive high risk HPV infection were randomized into interferon gel group and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in control group.
Conditions: HPV Infection
Intervention / Treatment:
DRUG: Yallaferon®
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Age 30 <= age <= 65 of age the sex life of female patients;
* , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells;
* , HPV DNA typing test for high-risk HPV positive (including a single high-risk type positive, and more high-risk type of positive and high-and low-risk hybrid positive).
15 kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68
Exclusion Criteria:
* (1) cervical intraepithelial neoplasia (CIN); (2), combined with a severe fungal, trichomonas vaginitis; (3), severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; (4), allergies or allergy to the drug known ingredients. (5), within 30 days to accept other clinical trials of drugs or are participating in clinical trials; (6), pregnant and lactating women and to be pregnant women; (7), the researchers do not consider it appropriate clinical trials.
|
NCT_ID
NCT01824992
|
Study_NameRecombinant Human Interferon a-2b Gel for HPV Gynecological Infections
| 5,056 |
Study Objectives
The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).
Conditions: Gastric Cancer
Intervention / Treatment:
DRUG: Isovorin, DRUG: TS-1
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Gastric cancer diagnosed histologically or cytologically
* Normal organ function of bone marrow, heart, liver and kidney
* Age of 20 <= age <= 77
Other inclusion applies
Exclusion Criteria:
* Serious infection, heart disease, complication or organ disorder
* Ongoing administration of flucytosine
* Pregnant or breastfeeding women
Other exclusion applies
|
NCT_ID
NCT00195572
|
Study_NameStudy Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
| 9,762 |
Study Objectives
This is an ongoing, Phase 1, open-label, multicenter, pilot study of the checkpoint antibodies ipilimumab and nivolumab in combination with radiotherapy (RT) in 18 subjects with unresectable Stage IV melanoma. The primary study objective is to evaluate the safety of study treatment. Secondary objectives are to evaluate objective response rate (ORR) and disease control rate (DCR) at Weeks 12 and 18, duration of response, progression-free survival (PFS), and overall survival (OS).
Conditions: Melanoma
Intervention / Treatment:
DRUG: Nivolumab, DRUG: Ipilimumab, RADIATION: Radiotherapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* Histologic diagnosis of Stage IV metastatic melanoma, with 1 melanoma lesion that could be safely irradiated and, in the opinion of the radiation oncologist, was of benefit to the subject to irradiate (note: subjects with primary ocular and mucosal melanoma were permitted). Lesions may have included, but were not limited to:
1. Symptomatic lymphadenopathy;
2. Bothersome cutaneous disease;
3. Hepatic metastases;
4. Pulmonary metastases.
* Excluding the lesion intended to undergo radiation, subjects must have had at least 1 unresectable, non-bony lesion that was measurable radiographically (based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
* Any number of prior therapies (including none). For subjects who had received prior systemic treatment with cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), programmed cell death-1 (PD-1), and/or programmed cell death ligand-1 (PD-L1) therapy, the last monoclonal antibody administration should have been no less than 4 weeks prior to start of this protocol therapy and all prior side effects must have resolved to grade 1 or less by the time of the start of this protocol therapy.
* Subjects must have:
* Completed investigational therapy, other immunotherapy, or prior RT at least 28 days before administration of the first dose of study drug(s)
* Completed chemotherapy or targeted therapy at least 14 days before administration of the first dose of study drug(s)
* Sufficiently recovered from prior surgery as determined by the treating Investigator.
Clinically significant toxicity or pharmacodynamic effects experienced during any prior therapy must have been resolved or stabilized before the first dose of study drug(s).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 1.
* Life expectancy >= 4 months.
* Screening laboratory parameters:
1. White blood cell count >= 2000/μL;
2. Absolute neutrophil count >= 1500/μL;
3. Platelets >= 100,000/μL;
4. Hemoglobin >= 9 g/dL;
5. Aspartate aminotransferase and alanine aminotransferase <= 3 × upper limit of normal (ULN);
6. Total bilirubin <= 1.5 × ULN (< 3 mg/dL for subjects with Gilbert's disease);
7. Serum creatinine <= 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula below):
* Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x serum creatinine in mg/dL];
* Male CrCl = [(140 - age in years) x weight in kg x 1.00] / [72 x serum creatinine in mg/dL].
* Age >= 18 years.
* Able and willing to give valid written informed consent.
Exclusion Criteria:
* Unresolved immune-related AEs following prior biological therapy. Subjects with asymptomatic endocrinopathy may have enrolled.
* Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents were permitted in the absence of active autoimmune disease.
* History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia Gravis).
* Other active, concurrent malignancy that required ongoing systemic treatment or interfered with radiographic assessment of melanoma response as determined by the Investigator.
* Active brain metastases or leptomeningeal metastases. Subjects with brain metastases were eligible if metastases had been treated and there was no magnetic resonance imaging (MRI) evidence of progression for 4 weeks or more after treatment was completed and within 28 days prior to the first dose of nivolumab administration. There must also have been no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
* Known immunodeficiency or human immunodeficiency virus, Hepatitis B, or Hepatitis C positivity. Antibody to Hepatitis B or C without evidence of active infection may have been allowed.
* History of severe allergic reactions to any unknown allergens or any components of the study drugs.
* Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
* Requirement of RT to treat brain metastases or receipt of any non-study systemic therapy for cancer or any other experimental/investigational treatment.
* Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
* Lack of availability for immunological and clinical assessments or post-study follow-up contact to determine relapse and survival.
* Women who were breastfeeding or who were pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) performed within 14 days of the first dose of study drug and by a urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours of the first dose of study drug(s).
* Females of childbearing potential who were sexually active with a nonsterilized male partner must have used 2 methods of effective contraception from screening, and must have agreed to continue using such precautions for 23 weeks after the final dose of investigational product; cessation of birth control after this point should have been discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method were not acceptable methods of birth control.
[Females of childbearing potential were defined as those who were not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).] Nonsterilized males who were sexually active with a female partner of childbearing potential must have used 2 acceptable methods of effective contraception from Day 1 and for 31 weeks after receipt of the final dose of investigational product.
* Any condition that, in the clinical judgment of the treating physician, was likely to interfere with the interpretability of the data or prevent the subject from complying with any aspect of the protocol or that may have put the subject at unacceptable risk.
|
NCT_ID
NCT02659540
|
Study_NamePilot Study of the Safety/Efficacy of Combination Checkpoint Blockade + External Beam Radiotherapy in Stage IV Melanoma
| 10,965 |
Study Objectives
The Vitamin D receptor gene (VDR) polymorphisms are the candidate genetic variants for susceptibility to autoimmune diseases. In the present study, the investigators aimed to assess the association between VDR polymorphisms and myasthenia gravis (MG) susceptibility and disease features in Chinese Han population.The patients with MG and healthy controls were genotyped for VDR rs1544410, rs2228570, rs731236, and rs7975232 polymorphisms using the improved multiple ligase detection reaction. Information on age at onset, acetylcholine receptor antibody (AChR-Ab) and muscle-specific kinase antibody (MuSK-Ab) status, thymus status, involved muscles at onset and Osserman type at the maximum worsening during 2 years follow-up were obtained and used as the grouping basis of sub-classifications. Intergroup comparisons of allele and genotype frequencies, haplotype distributions were performed between MG group and the control group, and between each pair of MG subgroups.
Conditions: Myasthenia Gravis, Ocular, Gene Polymorphism
Intervention / Treatment:
GENETIC: Genotype analysis for VDR rs1544410, rs2228570, rs731236, and rs7975232 polymorphisms
Location: China
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Clinical diagnosis of myasthenia gravis.
* Han Chinese population.
* Must be able to complete a 2-year follow-up visit.
Exclusion Criteria:
* Clinical data collection can not be completed.
* Poor compliance.
|
NCT_ID
NCT05380128
|
Study_NameAssociation Study Between VDR Gene Polymorphisms and Risk and Features of MG in Han Chinese Population
| 19,115 |
Study Objectives
This study is to determine the safety of IRX-2 Regimen combined with Nivolumab in patients with recurrent metastatic solid tumors. Researchers believe that this combination will have a tolerable safety profile and will increase the response rate in comparison to Nivolumab alone.
Conditions: Metastatic Cancer, Recurrent Cancer, Solid Tumor, Renal Cell Carcinoma, Urothelial Carcinoma, NSCLC, Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck
Intervention / Treatment:
DRUG: IRX 2, DRUG: Nivolumab
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:
* At least 18 years
* Participants must have histologically or cytologically confirmed renal cell carcinoma,urothelial carcinoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck or melanoma.
* Participants must have recurrent or metastatic disease that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
* Must be willing and able to give informed consent and adhere to protocol therapy; written informed consent and any locally required authorization must be obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
* Prior exposure to PD-1/PD-L1 inhibitor monotherapy, or prior exposure to CTLA-4 inhibitor monotherapy is allowed.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2
* Adequate normal organ and marrow function
* Participants who are receiving therapeutic anti-coagulant therapy are eligible.
* Palliative radiation therapy is allowed to non-target lesions at the discretion of the treating physician.
* Participants 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 outlined in RECIST version 1.1.
* Life expectancy of greater than 3 months.
* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment.
* Body weight must be greater than 66 pounds.
Exclusion Criteria:
* Prior exposure to a combination of IRX-2 regimen, PD-1/PD-L1 inhibitors and CTLA-4 inhibitors are excluded. Prior exposure to PD-1/PD-L1 inhibitors is allowed.
* Radiation therapy with a curable intent within 30 days of first dose of study treatment is excluded. However, radiation therapy with a palliative intent is allowed to treat after 14 days from the last dose of radiation.
* Any medical contraindications or previous therapy that would preclude treatment with the IRX-2 Regimen, or nivolumab.
* Any unresolved toxicity Grade 2 or greater from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
* Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with IRX-2, or nivolumab may be included only after consultation with the study physician.
* Active or prior documented autoimmune or inflammatory disorders
* Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment. Some exceptions apply.
* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.
* History of allogenic organ transplantation.
* Symptomatic cardiopulmonary disease, coronary artery disease, serious arrhythmia or chronic lung disease. Participants with these conditions who are stable with relatively minor symptoms and who are appropriate candidates for systemic treatments need not be excluded.
* Myocardial infarction within the last 3 months.
* Known infection with hepatitis B, hepatitis C, or HIV.
* Signs or symptoms of systemic infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection).
* Clinically significant gastritis or peptic ulcer disease
* Stroke or other symptoms of cerebral vascular insufficiency within the last 3 months.
* Allergy to ciprofloxacin (or other quinolones).
* Previous diagnosis of invasive cancer from which the individual is not disease-free AND that has required treatment within the past 3 years, except for superficial skin, cervical cancer in-situ, or early stage prostate or bladder cancer (i.e. treatment with curative intent and long term disease-free expectations).
* History of leptomeningeal carcinomatosis
* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
* Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 1 year after the last dose of study treatment.
|
NCT_ID
NCT03758781
|
Study_NameIRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors
| 14,039 |
Study Objectives
To evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.
Conditions: Head and Neck Neoplasms
Intervention / Treatment:
DRUG: Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy, DRUG: Concomitant cisplatin, 5-FU and radiotherapy
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion criteria:
* Histologically or cytologically proven squamous cell carcinoma of the head and neck.
* Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because of theY responsiveness to chemotherapy: tumors of the nasal and paranasal cavities, larynx and of the nasopharynx.
* Stage III or IV disease without evidence of distant metastases verified by chest X Ray and/or lung CT scan, abdominal ultrasound, or CT (liver function test abnormalities); bone scan in case of local symptoms.
* At least one measurable lesion.
* Tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a surgeon, a medical oncologist and a radiation oncologist).
* No previous chemotherapy or radiotherapy for any reason and no previous surgery for squamous cell carcinoma of the head and neck patients (other than biopsy) are allowed at time of study entry.
* Karnofsky performance status >= 70.
* No active alcohol addiction.
* Adequate bone marrow, hepatic and renal functions
* Patients must be available for treatment and follow-up.
Exclusion criteria
* Pregnant or lactating women or women of childbearing potential not using adequate contraception.
* Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
* Symptomatic peripheral neuropathy >= grade 2
* Symptomatic altered hearing >= grade 2
* Other serious illnesses or medical conditions including:a) Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.b) History of significant neurologic or psychiatric disorders including dementia or seizures.c) Active uncontrolled infection.d) Active peptic ulcer.e) Hypercalcemia.f) Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry
* History of hypersensitivity reaction to polysorbate 80
* Patients requiring intravenous alimentation.
* Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry.
* Concomitant treatment with any other anticancer therapy.
* Participation in a therapeutic clinical trial within 30 days of study entry
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
|
NCT_ID
NCT00357149
|
Study_NameNeoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Locally Advanced Squamous Cell Carcinoma of the Head and Neck Patients (SCCHNS)
| 11,837 |
Study Objectives
Recurrent respiratory papillomatosis (RRP) is the most common benign neoplasm of the larynx in the pediatric population. The impact of the disease on patients and families can be tremendous due to the need for frequent treatment. It would be highly beneficial to develop effective medical therapies as adjunctive measures to surgical ablation with the goal of reducing the frequency of reoccurrence.
Conditions: Recurrent Respiratory Papillomatosis
Intervention / Treatment:
DRUG: Cidofovir, DRUG: Placebo
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* 4 surgeries for RRP in last 12 months
Exclusion Criteria:
* Renal insufficiency
* Nephrotoxic drugs in the last 7 days
* Sulfa allergies
* Currently treated with systemic or topical HPV chemotherapeutic agents
* Females of childbearing potential with a positive pregnancy test
* Women who are breast feeding
|
NCT_ID
NCT00205374
|
Study_NameUse of Cidofovir for Recurrent Respiratory Papillomatosis
| 2,454 |
Study Objectives
This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: Bevacizumab, DRUG: liposomal doxorubicin, DRUG: paclitaxel, DRUG: topotecan
Location: Bosnia and Herzegovina, Germany, Sweden, Spain, Italy, Netherlands, Belgium, Greece, Denmark, Norway, Turkey, France, Finland, Portugal
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* female patients, >=18 years
* epithelial ovarian, fallopian tube or primary peritoneal cancer
* platinum-resistant disease (disease progression within <6 months of platinum therapy)
* EOCG performance status of 0 <= age <= 2
Exclusion Criteria:
* non-epithelial tumours
* ovarian tumours with low malignant potential
* previous treatment with >2 chemotherapy regimens
* prior radiotherapy to the pelvis or abdomen
|
NCT_ID
NCT00976911
|
Study_NameAURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
| 19,488 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.