NCT02536586已完成1 期
A Phase 1 Study of LY3023414 in Japanese Patients With Advanced 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
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants with LY3023414 Dose-Limiting Toxicities (DLT)
研究概览
简要总结
The main purpose of this study is to evaluate the tolerability of an investigational drug known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to another part(s) of the body. The study will also explore the safety of the drug. It will measure how much of the drug gets into the blood steam and how long the body takes to get rid of it. It will investigate anti-cancer activity.
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
LY3023414
Experimental
LY3023414 administered orally, twice daily in 21-day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
干预措施: LY3023414 (Drug)
结局指标
主要结局
Number of Participants with LY3023414 Dose-Limiting Toxicities (DLT)
时间窗: Cycle 1 (21 days)
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3023414(Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.))
- Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve (AUC) of LY3023414(Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.))
- Proportion of Participants With Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])(Baseline through study completion (estimated as up to five months))
研究者
研究点 (1)
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