NCT00434174已完成1 期
A Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) 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
- 48
- 试验地点
- 1
- 主要终点
- Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
研究概览
简要总结
This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.
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 —（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
everolimus + Pemetrexed - daily
Experimental
Daily treatment
干预措施: Everolimus (Drug)
everolimus + Pemetrexed - daily
Experimental
Daily treatment
干预措施: Pemetrexed (Drug)
everolimus + Pemetrexed - weekly
Experimental
Weekly treatment
干预措施: Everolimus (Drug)
everolimus + Pemetrexed - weekly
Experimental
Weekly treatment
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
时间窗: Over 18 weeks of combination treatment
次要结局
- Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST)(Over 18 weeks of combination treatment)
研究者
研究点 (1)
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