Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In 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
- 791
- 试验地点
- 169
- 主要终点
- Progression-Free Survival (PFS): Independent-Assessment
研究概览
简要总结
Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.
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
- •Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)
- •Majority component of conventional clear-cell type is mandatory
- •At least 1 measurable lesion (per RECIST)
排除标准
- •Prior systemic treatment for RCC
- •Evidence of current or prior central nervous system (CNS) metastases
- •Cardiovascular disease
- •Pregnant or nursing women
- •Additional criteria applies
研究组 & 干预措施
1
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
干预措施: Bevacizumab (Drug)
1
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
干预措施: Temsirolimus (Drug)
2
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
干预措施: Bevacizumab (Drug)
2
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
干预措施: Interferon-Alfa 9MU (Drug)
结局指标
主要结局
Progression-Free Survival (PFS): Independent-Assessment
时间窗: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
次要结局
- Progression-Free Survival (PFS): Investigator-Assessment(Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
- Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment(Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
- Overall Survival (OS)(Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012))