EUCTR2013-000286-36-FR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 GCT
Gustave Roussy0 个研究点开始时间: 2014年1月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •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 :
- •oHemoglobin ? 10.0 g/dL
- •oAbsolute neutrophil count ?1.5 x 109/L,
- •oPlatelet count ? 100 x 109/L,
- •Adequate organ function
- •oSerum 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
- •oAST/SGOT and ALT/SGPT = 1.5 x ULN
- •oBilirubin = 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Patients receiving an investigational drug 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
研究者
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