NCT01428141已完成1 期
A Phase I Study of E7050 in Subjects With Solid Tumors
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
- 18
- 主要终点
- Determination of the maximum tolerated dose (MTD)
研究概览
简要总结
The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to patients with advanced solid tumor and gastric 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
- 20 Years 至 74 Years（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
E7050
Experimental
干预措施: E7050 (Drug)
结局指标
主要结局
Determination of the maximum tolerated dose (MTD)
时间窗: During the Run-in Phase and Cycle 1 period (the first 5 weeks of treatment)
Determination of the MTD of E7050 given orally once daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT).
次要结局
未报告次要终点
研究者
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