A Randomized, Double-blind Study of the Effect of Avastin Plus Gemcitabine and Erlotinib Compared With Placebo Plus Gemcitabine and Erlotinib on Overall Survival in Patients With Metastatic Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 607
- 主要终点
- Duration of Overall Survival - Percentage of Participants With an Event
研究概览
简要总结
This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.
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
- Double
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
- •adult patients, >=18 years of age;
- •metastatic pancreatic cancer (adenocarcinoma);
- •good liver, kidney, and bone marrow function.
排除标准
- •previous systemic treatment for metastatic pancreatic cancer;
- •pregnant or lactating females;
- •fertile men, or women of childbearing potential, not using adequate contraception;
- •major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
- •current or recent treatment (within 30 days prior to starting study treatment) with another investigational drug, or participation in another investigational study.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
结局指标
主要结局
Duration of Overall Survival - Percentage of Participants With an Event
时间窗: Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized
Duration of overall survival (OS) was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.
Duration of Overall Survival - Time to Event
时间窗: Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized
Duration of OS was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median duration of survival was estimated using the Kaplan-Meier method.
次要结局
- Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib(Weeks 1, 3, 5, 7, and 9)
- Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment(Baseline and Week 8)
- Clinical Benefit Response (CBR)(Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized)
- Progression-Free Survival (PFS) - Percentage of Participants With an Event(Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression)
- Progression-Free Survival (PFS) - Time to Event(Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression)