Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,200
- 试验地点
- 172
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Primary Objective:
- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.
Secondary Objectives:
-
To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m².
-
To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:
-
Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause;
-
PSA Progression;
-
Pain progression;
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Tumor response in participants with measurable disease (RECIST 1.1);
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PSA response;
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Pain response in participants with stable pain at baseline.
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To compare Health-related Quality of Life (HRQoL).
-
To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.
详细描述
Participants were treated until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. 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 came 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 20 mg/m^2
Cabazitaxel 20 mg/m^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
干预措施: Cabazitaxel (XRP6258) (Drug)
Cabazitaxel 20 mg/m^2
Cabazitaxel 20 mg/m^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
干预措施: Prednisone (or Prednisolone) (Drug)
Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
干预措施: Cabazitaxel (XRP6258) (Drug)
Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
干预措施: Prednisone (or Prednisolone) (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.
次要结局
- Progression Free Survival (PFS)(From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months))
- Time to Tumor Progression(From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months))
- Percentage of Participants With Overall Objective Tumor Response(From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months))
- Time to PSA Progression(From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months))
- Percentage of Participants With PSA Response(From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months))
- Time to Pain Progression(From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months))
- Percentage of Participants With Pain Response(From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months))
- Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) 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 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks))
- Change From Baseline in FACT-P:Total Score as a Measure of HRQoL(Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks))
- Percentage of Participants With FACT-P Total Score Response(From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months))
- Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales(From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months))
- Time to Definitive Deterioration of ECOG PS Score From Baseline(From baseline until death or study cut-off date (maximum duration: 48 months))
- Time to Definitive Weight Loss by 5% and 10% From Baseline(From baseline until death or study cut-off date (maximum duration: 48 months))
- Time to First Definitive Consumption of Narcotic Medication(From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months))
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)(From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months))
- Plasma Clearance (CL) for Cabazitaxel(Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI)
- Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel(Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI)