NCT00730379已完成1 期
A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 87
- 主要终点
- To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.
研究概览
简要总结
This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients.
详细描述
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •You must have confirmed metastatic or advanced cancer that has not responded to standard therapy or where standard therapy does not exist
- •In Part C, patients must have a diagnosis of advanced or metastatic colorectal adenocarcinoma or non-small cell lung cancer, and must have received at least 1 but no more than three prior systemic therapy treatment regimens
- •You must be over the age of 18 years old
- •You must have a ECOG status performance of 0 or 1
- •You must have good organ function
- •You must be willing to have skin and/or tumor biopsies
排除标准
- •You have had cancer treatment within 4 weeks prior to entering the study or you still have bad side effects from previous therapies
- •You have an active infection that requires treatment
- •You are HIV positive or have a history of Hepatitis B or C
结局指标
主要结局
To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.
时间窗: MTD from Day 1 to Day 28 in Cycle 1 for disease progression
次要结局
- To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab(At prescribed timepoints as defined in the protocol)
研究者
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