An Open Label, Partially Randomised Phase II Study to Investigate the Efficacy and Safety of BIBW 2992 in Patients With Metastatic Colorectal Cancer Who Never Received Prior Anti-EGFR (Epidermal Growth Factor Receptor) Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 13
- 主要终点
- Percentage of Participants With Objective Response
研究概览
简要总结
This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BIBW 2992
Patients receive BIBW 2992 tablets once daily
干预措施: BIBW 2992 (Drug)
Cetuximab
Patients receive cetuximab intravenously once a week, every week
干预措施: Cetuximab (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response
时间窗: Baseline till progression or death, whichever came first, assessed up to 23 months
Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.
Percentage of Participants With Disease Control (DC)
时间窗: Baseline till progression or death, whichever came first, assessed up to 23 months
Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.
次要结局
- Progression Free Survival (PFS)(Baseline till progression or death, whichever came first, assessed up to 23 months)
- Overall Survival (OS) Time(Baseline till death, assessed up to 23 months)
- Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)(day 8)