A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 649
- 主要终点
- Overall Survival (OS) Duration
研究概览
简要总结
This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (>)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 (Participant, Investigator)
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
- •metastatic renal cell cancer (clear cell type);
- •nephrectomy;
- •absence of proteinuria.
排除标准
- •prior systemic treatment for metastatic renal cell cancer;
- •major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start;
- •presence of brain metastases or spinal cord compression;
- •ongoing need for full dose anticoagulants;
- •uncontrolled hypertension;
- •clinically significant cardiovascular disease.
研究组 & 干预措施
Bevacizumab + IFN-Alfa-2A
Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.
干预措施: Bevacizumab [Avastin] (Drug)
Bevacizumab + IFN-Alfa-2A
Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.
干预措施: Interferon alfa 2a [Roferon] (Drug)
Placebo + IFN-Alfa-2A
Placebo matched with Bevacizumab infusions will be administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A will be administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
干预措施: Interferon alfa 2a [Roferon] (Drug)
Placebo + IFN-Alfa-2A
Placebo matched with Bevacizumab infusions will be administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A will be administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS) Duration
时间窗: Baseline until death (up to 4.25 years)
Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.
Percentage of Participants Who Died
时间窗: Baseline up to 4.25 years
次要结局
- Percentage of Participants With Disease Progression or Death(Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years))
- Percentage of Participants With Treatment Failure(Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years))
- Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)(Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years))
- Time to Treatment Failure (TTF) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)(Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years))
- Percentage of Participants With Objective Response According to mRECIST(Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years))
- Change From Baseline in Karnofsky Performance Status(Baseline, Week 7, 15, 23, 31, 43)
- Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)(Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years))
- Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)(Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years))