NCT00669097已完成1 期
An Open-Label, Non-Randomized, Single-Center, Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion (ADME) of TKI258 After a Single Oral Administration of TKI258 500mg and to Assess the Preliminary Safety of TK258 400mg Once Daily in Patients With Advanced Solid Malignancies
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
- 13
- 试验地点
- 1
- 主要终点
- Cohort1: Find out about the routes and rates of excretion of TKI258 and its metabolites
研究概览
简要总结
This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients) will receive 400mg TKI258.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TKI258
Experimental
干预措施: TKI258 (Drug)
结局指标
主要结局
Cohort1: Find out about the routes and rates of excretion of TKI258 and its metabolites
时间窗: Day 15
Cohort 2: Safety and Tolerability of TKI258
时间窗: Time to patient withdrawal due to disease progression or tolerability issues
次要结局
- Cohort 1: Safety and tolerability of TKI258(Time to patient withdrawal due to disease progression or tolerability issues)
- Cohort 1: Preliminary anti-tumor activity of TKI258(Time to tumor progression)
- Preliminary Anti-tumor activity of TKI258(Time to tumor progression)
研究者
研究点 (1)
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