A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Cmax (Maximum Plasma Concentration) of FTD
研究概览
简要总结
The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.
详细描述
This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the first cycle (Day1 and Day 12) of therapy in all consenting 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has provided written informed consent prior to performance of any study procedure.
- •Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor.
- •Is able to take medications orally.
- •Has adequate organ function (bone marrow, kidney and liver).
- •Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.
排除标准
- •Has received TAS-
- •Has suffered serious complications.
- •Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
- •Has had prior gastrectomy.
- •Is a pregnant or lactating female or male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment.
研究组 & 干预措施
TAS-102
干预措施: TAS-102 (Drug)
结局指标
主要结局
Cmax (Maximum Plasma Concentration) of FTD
时间窗: Multiple time points on Day 1 and Day 12 of Cycle 1.
Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD
时间窗: Multiple time points on Day 1 and Day 12 of Cycle 1.
AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD
时间窗: Multiple time points on Day 1 and Day 12 of Cycle 1.
次要结局
未报告次要终点