跳至主要内容
临床试验/NCT02115165
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

Gustave Roussy, Cancer Campus, Grand Paris1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014年7月23日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验