EUCTR2011-003156-39-FI进行中（未招募）不适用
OPEN, SINGLE-ARM, MULTICENTER, PHASE II TRIAL INVESTIGATING THE SAFETY OF BIWEEKLY CABAZITAXEL IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER PATIENTS PREVIOUSLY TREATED WITH A DOCETAXEL-CONTAINING REGIMEN - PROSTY II
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Metastatic castration resistant prostate cancer
- •- Disease progression during or after docetaxel-containing regimen for mCRPC
- •- Surgical or medical castration
- •- WHO performance status < or = 2
- •- Age > 18 years
- •- Adequate bone marrow, liver and renal functions:
- •Hematology:
- •- neutrophils > 1.5 x 109/ l
- •- hemoglobin > 100 g/l
- •- platelets > 100 x 109/l
- •Hepatic function:
- •- total bilirubin < or = 1 x UNL
- •- ALAT and ASAT < 2.5 x UNL, Alkaline Phosphate < or = 6 x UNL. In the presence of extensive bone disease, alkaline phosphate > 6 x UNL is accepted
- •Renal function:
- •-Creatinine < 1.5 x UNL (ie NCI grade < 1)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
- •- Prior therapy with radioisotopes
- •- Other malignant disease/ malignancy (except superficial non-melanoma skin cancer) within the past 5 years
- •- Serious liver disease
- •- History of severe hypersensitivity reaction (grade > 3) to polysorbate 80 containing drugs
- •- Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who already are on these treatments)
- •- Other serious illness or medical condition:
- •(a) Serious cardiac disease; ischemic or thromboembolic cardiac disease, pulmonary
- •emboli, cardiac infarction within 12 months
- •(b) Active infection
- •(c) Active peptic ulcer, uncontrolled diabetes mellitus or other contraindications for the use
- •of corticosteroids
- •(d) Auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis)
- •(e) Active grade > 2 polyneuropathy
研究者
相似试验
进行中（未招募）
1 期
A PHASE 2, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO DETERMINE THE EFFICACY AND SAFETY OF SINGLE-AGENT LENALIDOMIDE (REVLIMID) IN PATIENTSWITH MANTLE CELL NHL WHO HAVE RELAPSED OR PROGRESSED AFTER TREATMENT WITH BORTEZOMIB OR ARE REFRACTORY TO BORTEZOMIB - NDPATIENTS WITH MANTLE CELL NHL WHO HAVE RELAPSED OR PROGRESSED AFTER TREATMENT WITH BORTEZOMIB OR ARE REFRACTORY TO BORTEZOMIBMedDRA version: 9.1Level: HLTClassification code 10026798Term: Mantle cell lymphomasEUCTR2007-007756-34-ITCelgene Corporation133
进行中（未招募）
1 期
A PHASE II, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE-AGENT LENALIDOMIDE (REVLIMID®) IN SUBJECTS WITH RELAPSED OR REFRACTORY AGGRESSIVE NON-HODGKIN’S LYMPHOMARelapsed or refractory aggressive non-Hodgkin's lymphomaMedDRA version: 8.1Level: PTClassification code 10029610Term: Non-Hodgkin's lymphoma unspecified histology aggressive refractoryEUCTR2006-004500-40-FRCelgene Corporation128
进行中（未招募）
1 期
A PHASE II, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE-AGENT LENALIDOMIDE (REVLIMID®) IN SUBJECTS WITH RELAPSED OR REFRACTORY T-CELL NON-HODGKIN’S LYMPHOMA - TCL-001•Relapsed or refractory T-cell non Hodgkin's lymphomaMedDRA version: 9.1Level: HLGTClassification code 10018865Term: Haematopoietic neoplasms (excl leukaemias and lymphomas)EUCTR2007-002171-13-FRCelgene International Sàrl80
进行中（未招募）
不适用
A PHASE II, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE-AGENT LENALIDOMIDE (REVLIMID®) IN SUBJECTS WITH RELAPSED OR REFRACTORY T-CELL NON-HODGKIN’S LYMPHOMA - The EXPECT Trial•Relapsed or refractory T-cell non Hodgkin's lymphomaMedDRA version: 9.1Level: HLGTClassification code 10018865Term: Haematopoietic neoplasms (excl leukaemias and lymphomas)EUCTR2007-002171-13-BECelgene International Sàrl80
进行中（未招募）
不适用
A PHASE II, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE-AGENT LENALIDOMIDE (REVLIMID®) IN SUBJECTS WITH RELAPSED OR REFRACTORY AGGRESSIVE NON-HODGKIN’S LYMPHOMARelapsed or refractory aggressive non-Hodgkin's lymphomaMedDRA version: 8.1Level: PTClassification code 10029610Term: Non-Hodgkin's lymphoma unspecified histology aggressive refractoryEUCTR2006-004500-40-ESCelgene Corporation218