NCT00466466已完成1 期
A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated 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
- 20
- 试验地点
- 6
- 主要终点
- Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1
研究概览
简要总结
This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.
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 —（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
Daily dosing RAD001
Experimental
干预措施: Everolimus (Drug)
Weekly dosing RAD001
Experimental
干预措施: Everolimus (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1
时间窗: Day 21
次要结局
- Overall tumor response(Every 6-8 weeks)
- Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen(within 6 cycles (Day 126))
- PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles(During the first 6 cycles)
研究者
研究点 (6)
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