A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 755
- 试验地点
- 26
- 主要终点
- Overall Survival
研究概览
简要总结
This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
Mitoxantrone + Prednisone
Mitoxantrone + Prednisone
干预措施: mitoxantrone (Drug)
Mitoxantrone + Prednisone
Mitoxantrone + Prednisone
干预措施: prednisone (Drug)
Cabazitaxel + Prednisone
Cabazitaxel + Prednisone
干预措施: cabazitaxel (XRP6258) (RPR116258) (Drug)
Cabazitaxel + Prednisone
Cabazitaxel + Prednisone
干预措施: prednisone (Drug)
结局指标
主要结局
Overall Survival
时间窗: From the date of randomization up to 104 weeks (study cut-off)
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.
次要结局
- Time to Progression Free Survival (PFS)(From the date of randomization up to 104 weeks (study cut-off))
- Overall Tumor Response(From the date of randomization up to 104 weeks (study cut-off))
- Time to Tumor Progression(From the date of randomization up to 104 weeks (study cut-off))
- Time to Prostatic Specific Antigen (PSA) Progression(at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off))
- PSA (Prostate-Specific Antigen) Response(from baseline up to 104 weeks (study cut-off))
- Time to Pain Progression(from baseline up to 104 weeks (study cut-off))
- Pain Response(from baseline up to 104 weeks (study cut-off))