NCT00456833已完成1 期
A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy
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
- 248
- 试验地点
- 1
- 主要终点
- Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.
研究概览
简要总结
This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 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
RAD 5mg/day + erlotinib
Experimental
干预措施: RAD001 (Drug)
erlotinib 150mg/day
Active Comparator
干预措施: RAD001 (Drug)
erlotinib 150mg/day
Active Comparator
干预措施: erlotinib (Drug)
结局指标
主要结局
Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.
时间窗: first 28 days of combined treatment
Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1
时间窗: at baseline and after 8 weeks of treatment
次要结局
- Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue(Dec 2009)
- Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression(at baseline, monthly until month 4 then q2months until progression)
- Phase 2: Safety and steady state drug levels evaluated monthly(Monthly)
研究者
研究点 (1)
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