NCT01337310Unknown1 期
A Phase I Study of Tesetaxel Administered Once Every 21 Days to Japanese Subjects With Advanced Solid Tumors
Genta Incorporated1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose in mg/m2 based on the dose-limiting adverse events that occur
研究概览
简要总结
Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of tesetaxel in Japanese patients has been limited. This study is being conducted to determine the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to Japanese patients.
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
- 20 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
Tesetaxel
Experimental
Tesetaxel administered orally once every 21 days for at least 2 cycles
干预措施: Tesetaxel (Drug)
结局指标
主要结局
Maximum tolerated dose in mg/m2 based on the dose-limiting adverse events that occur
时间窗: First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)
次要结局
- Dose-limiting toxicities (adverse events that result in a reduction in the dose of tesetaxel in the dose-escalation scheme)(First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period))
- Percentage of patients with adverse events(Through 30 days after the last dose of tesetaxel)
- Tumor response rate(After Cycle 2 (expected to be after Day 42 counting from the date of first dose of tesetaxel))
研究者
研究点 (1)
Loading locations...
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