NCT00478634已完成1 期
An Open-label, Multicenter Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab (if Given as Part of Local Standard Practice) in Patient With Metastatic Colorectal Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 16
- 主要终点
- Dose Limiting Toxicities
研究概览
简要总结
This study will assess the safety of RAD001 when given together with cetuximab and irinotecan
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（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
A1: RAD001 + cetuximab + irinotecan
Experimental
RAD001 30mg weekly oral, 400mg/m2, loading i.v. (250mg/m2 for subsequent weekly dose i.v.), 350mg/m2 every 3 weeks i.v.
干预措施: RAD001, Cetuximab, Irinotecan (Drug)
B1 dose: RAD001 + cetuximab + irinotecan
Experimental
RAD001 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v.
干预措施: RAD001, Cetuximab, Irinotecan (Drug)
结局指标
主要结局
Dose Limiting Toxicities
时间窗: at end of cycle 2
each cycle was 21 days
次要结局
- Pharmacokinetics of RAD001, Irinotecan and SN-38
- Progressions Free Survival
- Overall Survival
- Objective Response Rate
研究者
研究点 (16)
Loading locations...
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