Combination of Cetuximab & MWT Inhibitor Savolitinib in the Treatment of Ras Wild-Type Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Safety and tolerability based on regular clinical assessment and NCI Common Terminology Criteria for Adverse Events
研究概览
简要总结
Two-part phase 1B clinical trial combining cextuximab and savolitinib for treating Ras wild-type colorectal cancer (CRC). Part 1 will assess the safety and tolerability of this drug combination and will include patients with squamous cell carcinoma of the head and neck cancer, as well as patients with CRC. Part 2 of the study, the focus of this registration, will obtain further safety data for the combination of cextuximab and savolitinib and will look at the efficacy of cextuximab and savolitinib in Ras wild-type mCRC that was previously treated and relapsed on cetuximab or panitumumab.Correlative studies will examine tumor and blood specimens for mechanisms of anti-EGFR resistance and response to MET inhibition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
cetuximab and savolitinib
Following assessment in Part 1 of dose-limiting toxicity and maximum tolerated dose, this drug combination will be administered in Part 2 of the study to assess safety, tolerability, response rate, and progression-free survival.
干预措施: cetuximab and savolitinib (Drug)
结局指标
主要结局
Safety and tolerability based on regular clinical assessment and NCI Common Terminology Criteria for Adverse Events
时间窗: start of treatment to 3 years from treatment initiation
次要结局
- Response to treatment measured by RECIST (Response Evaluation Criteria in Solid tumors) criteria(start of treatment to disease progression/recurrence, up to 3 years)
- Progression free survival(start of treatment to disease progression, up to 3 years)