A Phase I, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 6
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
研究概览
简要总结
A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumors.
详细描述
This is a Phase 1, open-label, non-randomized, dose escalation study of TAS-119 evaluating the safety, tolerability, PK, pharmacogenomics, pharmacodynamics, and preliminary antitumour activity in patients with advanced and unresectable solid tumours. The study will evaluate TAS-119 monotherapy, employing two sequential phases.
- A Dose Escalation Phase
- An Expansion Phase
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 —（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
TAS-119 Monotherapy
Dose Escalation:
A Monotherapy Dose-Escalation Phase Performed in Approximately 5 Dose Levels (3 to 12 Patients Per Dose Level) to Determine the MTD for TAS-119 Given Orally (PO), Twice-Daily (BID) in a 28-Day Treatment Cycle; and:
Dose Expansion:
A Monotherapy Expansion Phase in Which Approximately 40 Additional Patients will be Enrolled to Further Evaluate the Recommended Phase II Dose (RP2D)
干预措施: TAS-119 (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
时间窗: Up to 2.5 Years
Identify the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of TAS-119
次要结局
未报告次要终点