NCT00750178已完成1 期
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer
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
- 30
- 主要终点
- Safety, tolerability, and PK of MK0683
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0683 in patients with advanced 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
- •Patients 18 years or older
- •Must agree to consume high fat meal and agree to fasting conditions
- •Limit alcohol consumption
排除标准
- •Patient has a history of drug or alcohol abuse within 5 years of start of study
- •Patient is known to have HIV
- •Patient has participated in another investigational study within 4 weeks of start of study
- •Patient cannot stop taking certain medications or herbal remedies
- •Patient will require immunologic, radiation, surgery, or chemotherapy during the study
- •Patient requires frequent blood transfusions
- •Female patient is pregnant or nursing
- •Patient has an active Hepatitis B or C infection
研究组 & 干预措施
A
Experimental
MK0683
干预措施: vorinostat (MK0683 ) (Drug)
结局指标
主要结局
Safety, tolerability, and PK of MK0683
时间窗: 28 Days
次要结局
- Urinary excretion of MK0683(28 days)
研究者
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