NCT01576029已完成2 期
Phase II Randomized Study of Continuing Treatment With Docetaxel Versus Switching to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in the First Line Treatment of Patients With Castration-Resistant Metastatic Prostate Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 2
- 试验地点
- 8
- 主要终点
- Median time to PSA progression
研究概览
简要总结
Primary Objective:
- To compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or increase of up to 24% in PSA levels.
Secondary Objectives:
- PSA response rate
- Overall survival (OS)
- Incidence of Adverse Events
详细描述
Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 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
Docetaxel
Active Comparator
75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks
干预措施: DOCETAXEL (XRP6976) (Drug)
Cabazitaxel
Experimental
25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks
干预措施: CABAZITAXEL (XRP6258) (Drug)
结局指标
主要结局
Median time to PSA progression
时间窗: up to 60 days
次要结局
- PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA(up to 60 days)
- Overall Survival: Median time elapsed between the date of starting treatment until death by any cause(up to a maximum of 2 years)
- Number of patients with adverse events(up to a maximum of 2 years)
研究者
研究点 (8)
Loading locations...
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