Multicentre, Single-arm, Open Label Clinical Trial Intended to Provide Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen and to Document Safety of Cabazitaxel in These Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 984
- 试验地点
- 165
- 主要终点
- To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen
研究概览
简要总结
The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients.
Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cabazitaxel
Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
干预措施: CABAZITAXEL (Drug)
结局指标
主要结局
To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen
时间窗: Up to 30 weeks
次要结局
- To document safety of cabazitaxel in these patients(Up to 35 weeks)