NCT01610479已完成1 期
A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
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
- 120
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of TAS-114 when used in combination with S-1
研究概览
简要总结
This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.
详细描述
This is a phase 1, open-label, non-randomized, dose-escalating safety, tolerability, and pharmacokinetic study of TAS-114 in combination with S-1 in patients with advanced solid tumors.
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
- •Life expectancy of at least 3 months
- •Histological or cytological documentation of advanced solid tumors
- •ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
- •Adequate bone marrow, liver and renal function
- •Women of childbearing potential and men must agree to use adequate contraception
排除标准
- 未提供
研究组 & 干预措施
TAS-114/S-1
Experimental
TAS-114 plus S-1
干预措施: TAS-114 + S-1 (Drug)
结局指标
主要结局
Maximum tolerated dose of TAS-114 when used in combination with S-1
时间窗: 4 years
次要结局
- Pharmacokinetic profiles (peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of TAS-114, S-1 components and its metabolite)(4 years)
- Response rate(4 years)
- Disease control rate(4 years)
- Progression free survival(4 years)
研究者
研究点 (1)
Loading locations...
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