NCT00659568已完成1 期
A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus
研究概览
简要总结
RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma.
详细描述
OBJECTIVES:
Primary
- To establish the maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus in patients with advanced solid cancers or lymphoma.
Secondary
- To determine the toxicity and safety, with particular reference to glucose and lipid deregulation, of this regimen in these patients.
- To assess antitumor activity, including tumor response rate and time to progression, in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
结局指标
主要结局
Maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus
次要结局
- Toxicity and safety, with particular reference to glucose and lipid deregulation
- Objective response
- Survival
- Antitumor activity, including tumor response rate and time to progression
- Frequency and severity of adverse events
研究者
研究点 (2)
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