Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,168
- 试验地点
- 167
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Primary Objective:
- To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.
Secondary Objectives:
-
To evaluate safety in the 3 treatment arms.
-
To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for:
-
Progression Free Survival (PFS) (RECIST 1.1)
-
Tumor progression free survival (RECIST 1.1)
-
Tumor response in participants with measurable disease (RECIST 1.1),
-
PSA response
-
PSA-Progression free survival (PSA-PFS).
-
Pain response in participants with stable pain at baseline
-
Pain progression free survival
-
Time to occurrence of any skeletal related events (SRE)
-
To compare Health-Related Quality of Life (HRQL).
-
To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.
详细描述
Participants were treated until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. All participants were followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever comes first.
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
Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal.
干预措施: Cabazitaxel (XRP6258) (Drug)
Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal.
干预措施: Prednisone (Drug)
Cabazitaxel 20 mg/m^2
Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
干预措施: Cabazitaxel (XRP6258) (Drug)
Cabazitaxel 20 mg/m^2
Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
干预措施: Prednisone (Drug)
Docetaxel 75 mg/m^2
Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
干预措施: Docetaxel (XRP6976) (Drug)
Docetaxel 75 mg/m^2
Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
干预措施: Prednisone (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )
OS 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, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.
次要结局
- Progression Free Survival (PFS)(Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months))
- Time to Tumor Progression Free Survival(Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months))
- Percentage of Participants With Overall Objective Tumor Response(Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months))
- Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)(Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months))
- Skeletal Related Events (SRE) Free Survival(Baseline until occurrence of first SRE or death (maximum duration: 51 months))
- Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)(Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks))
- Percentage of Participants With PSA Response(Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months))
- Time to Pain Progression Free Survival (Pain PFS)(Baseline until disease progression, death or study cut-off date (maximum duration: 51 months))
- Percentage of Participants With Pain Response(Baseline until pain progression, death or study cut-off date (maximum duration: 51 months))
- Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL(Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks))