A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 626
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus], administered intravenously [IV] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.
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
- All
- 接受健康志愿者
- 否
入选标准
- •This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease,
排除标准
- •Subjects with central nervous system (CNS) metastases
- •Prior anticancer therapy for RCC
- •Prior investigational therapy/agents within 4 weeks of randomization
研究组 & 干预措施
A
干预措施: Interferon Alfa (Drug)
B
干预措施: CCI-779 (Drug)
C
干预措施: Interferon Alfa and CCI-779 (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline up to Month 80
Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
次要结局
- Progression-Free Survival (PFS)(Baseline, monthly until tumor progression or death (up to Month 80))
- Percentage of Participants With Objective Response(Baseline, every 2 months until tumor progression or death (up to Month 80))
- Percentage of Participants With Clinical Benefit(Baseline, every 2 months until tumor progression or death (up to Month 80))
- Duration of Response (DR)(Baseline, every month until tumor progression or death (up to Month 80))
- Time to Treatment Failure (TTF)(Baseline, every month until tumor progression or death (up to Month 80))
- Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)(Baseline to Month 80)
- European Quality of Life Health Questionnaire (EQ-5D) - Index Score(Baseline)