A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial
研究概览
简要总结
Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC)
Part 2: To compare median duration of progression free survival (PFS)
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
- •Biopsy proven MCRC
- •Prior irinotecan allowed
- •Prior Erbitux allowed
排除标准
- •No prior brivanib
- •No prior combination of irinotecan with Erbitux
- •No secondary malignancies
- •No anti-coagulation therapy
- •No prior history of blood clots requiring anti-coagulation
研究组 & 干预措施
Arm 1 - Phase 1
Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo
干预措施: Cetuximab (Drug)
Arm 1 - Phase 1
Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo
干预措施: Irinotecan (Drug)
Arm 1 - Phase 1
Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo
干预措施: Brivanib (Drug)
Arm 1 - Phase 1
Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo
干预措施: Brivanib Placebo (Drug)
Arm 2 - Phase 2
Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo
干预措施: Cetuximab (Drug)
Arm 2 - Phase 2
Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo
干预措施: Irinotecan (Drug)
Arm 2 - Phase 2
Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo
干预措施: Brivanib (Drug)
Arm 2 - Phase 2
Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo
干预措施: Brivanib Placebo (Drug)
结局指标
主要结局
Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial
时间窗: PK C1D1-C2-D3, biomarker throughout the study
Safety and tolerability of interventions will be collected
时间窗: throughout the study on Part II
次要结局
- Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects(throughout the study on Part II)