NCT01074086已完成1 期
Multicentric Study of GOELAMS Phase I Evaluation of RAD001 in Association With Aracytine and Daunorubicine in AML Treatment in Patients Less Than 65 Years in Relapse More Than One Year After First Complete Remission
French Innovative Leukemia Organisation1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- maximal dose tolerated
研究概览
简要总结
A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse
详细描述
The primary objective of the study is to determinate the maximal tolerate dose and evaluate the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I study.
研究设计
- 研究类型
- Interventional
- 干预模型
- Factorial
- 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
- •patients from 18 to 65 years old
- •AML in relapse more than 1 year after CR
- •inform consent signed
排除标准
- •age more than 65
- •cardiac insufficiency
- •renal insufficiency
- •hepatic disease
- •other type of AML
- •blastic MCL
- •HIV positive serology
- •other malignancy
- •pulmonary infection
研究组 & 干预措施
RAD 001
Experimental
RAD 001 in day 1 and day 7 from 10 mg to 50 mg
干预措施: RAD 001 (Drug)
结局指标
主要结局
maximal dose tolerated
时间窗: 40 days
5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step
次要结局
- Biological study(Day 1 and Day 7)
研究者
研究点 (1)
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