jRCT2080224130已完成1 期
An Open-label, Crossover Study to Compare Different Formulations and to Evaluate Effect of Food on Pharmacokinetics of TAS-116 in Patients with Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- PK parameter
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open-label, two-cohort, respective two-arms, randomized phase I study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Key inclusion criteria
- •Provided written informed consent
- •Histologically or cytologically confirmed solid tumor.
- •Has a lack of response to conventional therapy or no availability of generally acknowledged standard therapy
- •Is able to take medications orally and to eat meals enough
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Women of childbearing potential must have a negative pregnancy test at baseline.
排除标准
- •Key exclusion criteria
- •Has gastrointestinal dysfunction (eg, history of gastrectomy, including a little gastrectomy) that may markedly interfere with the absorption of TAS-116
- •Has a serious illness or medical condition
- •Women who are pregnant, breastfeeding
结局指标
主要结局
PK parameter
Comparison of each PK parameter of TAS-116 (Cmax, AUClast, and AUCinf).
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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