An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 27
- 主要终点
- Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day
研究概览
简要总结
The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no appropriate treatment is available.
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 75 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
1
干预措施: E7080 (Drug)
结局指标
主要结局
Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day
时间窗: up to 4 weeks
The MTD was defined as the highest dose at which no dose limiting toxicity (DLT) was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.
DLT of E7080 Repeatedly Administered Twice a Day
时间窗: up to 4 weeks
DLTs were defined as grade 3 or more platelet count decrease, grade 4 neutropenia, any grade 3 or more nonhematologic toxicity (with exceptions of grade 4 hypertension not controlled by any antihypertensive drugs and grade greater than or equal to 3 vomiting and diarrhea not controlled by antiemetic or antidiarrheal drugs), and failure to administer more than 75% of the planned doses of E7080 during the same cycle due to toxicity.
次要结局
- To Elucidate the Pharmacokinetic Profile of E7080(Every 3 weeks)
- To Make Exploratory Analyses of Pharmacodynamic Markers(Every 3 weeks)
- Number of Participants With Adverse Events / Serious Adverse Events(Until tumor progression, unacceptable toxicity, or withdrawal due to other reasons.)
- Determine the Clinical Dose for Phase II Study Based on Safety and Pharmacokinetic Profile(Every 3 weeks)
- Evaluate the Anti-tumor Activity of E7080(Every 3 weeks)