NCT02115165已完成2 期
A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Favorable response
研究概览
简要总结
Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing and limited peripheral neuro-toxicity, two major potential advantages in patients with advanced NSGCTs.
Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have demonstrated activity in pre-treated GCTs and are now part of standard treatment, but cabazitaxel has not yet been tested in patients with NSGCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 15 years or older
- •Evidence of advanced NSGCT documented either by pathology or by elevated tumor markers (AFP or hCG) and a compatible clinical presentation
- •Primary site located in either the testis, the retroperitoneum or the mediastinum
- •Progressive disease after at least 2 lines of chemotherapy for advanced NSGCT (ie, non-stage I)
- •In case of brain metastases, confirm that patients should be stable / controlled with corticosteroid/anti seizures agents
- •No other progressive carcinoma within previous the 5 years, except for basal-cell carcinoma of the skin
- •Life expectancy >/= 3 months
- •Adequate hematologic function :
- •Hemoglobin >/= 10.0 g/dL
- •Absolute neutrophil count >/= 1.5 x 10 ^ 9/L,
- •Platelet count >/= 100 x 10 ^ 9/L,
- •Adequate organ function
- •Serum creatinine < 1.5 x ULN. If serum creatinine 1.0 - 1.5 x ULN, creatinine clearance calculated (or measured) according to CKD-EPI formula (see Appendix B) > 60 mL/min
- •AST/SGOT and ALT/SGPT </= 1.5 x ULN
- •Bilirubin </= 1.5 x ULN
- •Information delivered to patient and informed consent form signed by the patient or his legal representative
- •Patient affiliated to a social security system or beneficiary of the same
排除标准
- •Patients receiving anti cancer therapy within 4 weeks prior to enrolment
- •Previous radiotherapy within 4 weeks prior to enrolment
- •Serious uncontrolled concurrent medical illness
- •History of severe hypersensitivity reaction (>/= grade 3) to polysorbate 80 containing drugs or to other taxanes
- •Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix A). A one week wash-out period is necessary for patients who are already on these treatments.
- •Patient with reproductive potential not implementing accepted and effective method of contraception for up to 6 months after the last dose of cabazitaxel.
- •Active Grade >/= 3 peripheral neuropathy
- •Patients who have had a major surgery within 4 last weeks prior enrolment
- •Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed
研究组 & 干预措施
Cabazitaxel
Experimental
干预措施: Cabazitaxel (Drug)
结局指标
主要结局
Favorable response
时间窗: Assessed every 6 weeks from start of treatment up to 72 months
To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT)
次要结局
- Response rate on brain metastases(Assessed every 6 weeks after treatment start up to 72 months)
- Progression free survival(Assessed every 6 weeks from treatment start to progression up to 72 months)
- Overall survival(Assessed every 3 weeks after treatment start up to 72 months)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Phase II-b Randomized Clinical Trial of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard TreatmentColorectal CancerNCT02204332Hospital Clinico Universitario de Santiago38
进行中（未招募）
不适用
A prospective phase II trial of cabazitaxel in male patients with chemotherapy pre-treated metastatic non-seminomatous germ-cell tumors - CABA GCTpatients with pre-treated metastatic and /or primary mediastinal non-seminomatous germ-cell tumorsEUCTR2013-000286-36-FRGustave Roussy
已完成
2 期
Cabazitaxel in Relapsed and Metastatic NSCLCNSCLCNCT01852578Hellenic Oncology Research Group46
进行中（未招募）
1 期
Study of cabazitaxel in patients with metastatic breast cancer previously treated with taxanesEUCTR2011-003625-97-GRHellenic Cooperative Oncology Group
终止
2 期
Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial MetastasesMetastatic Breast Cancer With Intracranial MetastasesNCT01934894SCRI Development Innovations, LLC11