A Phase I, 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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Identify Maximum Tolerated Dose (MTD) in mg/kg
研究概览
简要总结
A Phase I, Open-Label, International, Multicenter, Non-Randomized, Dose-Escalating Safety, Tolerance and Pharmacokinetic Study of Oral Administration of TAS-114 in Combination with S-1 in a Twice Daily Schedule for 14 Days in Patients with Advanced Solid Tumors.
详细描述
This is an open-label, non-randomized, dose-escalation Phase I study of TAS-114 administered in combination with S-1, evaluating the safety, tolerability, pharmacokinetics and preliminary antitumor activity of the TAS-114/S-1 regimen in patients with advanced solid tumors.
The study will be conducted in two parts: a Dose-Escalation Phase (Part 1) to determine the MTD; and an Expansion Phase (Part 2) to further evaluate the safety and preliminary efficacy with the MTD. Patients will receive the study medication according to the proposed treatment schedule until disease progression (PD), occurrence of intolerable side effects, removal by the Investigator or withdrawal of consent. A patient is considered discontinued from study treatment when TAS-114 is discontinued.
Male or female patients age 18 years or older with confirmed advanced solid tumor(s) for which no standard therapy exists.
TAS-114/S-1 will be administered BID for 14 days followed by a 7-day recovery period, every 21 days (1 cycle) in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Has provided written informed consent.
- •Is ≥18 years of age
- •Has histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no standard therapy exists.
- •Expansion Phase only: Has at least one measurable lesion
- •Is able to take medications orally (e.g., no feeding tube).
- •Has adequate organ function
- •Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug.
- •Is willing and able to comply with scheduled visits and study procedures.
排除标准
- •Has received treatment with any proscribed treatments within specified time frames prior to study drug administration.
- •Has a serious illness or medical condition(s)
- •Is receiving concomitant treatment with drugs that may interact with S-1
研究组 & 干预措施
Dose Escalation TAS-114 (PART 1)
Each cycle will be 21 days: 14 days of treatment and 7 days recovery. TAS-114 and S-1 will be escalated according to a defined dosing table and specific DLT criteria.
干预措施: TAS-114 (Drug)
Dose Escalation TAS-114 (PART 1)
Each cycle will be 21 days: 14 days of treatment and 7 days recovery. TAS-114 and S-1 will be escalated according to a defined dosing table and specific DLT criteria.
干预措施: S-1 (Drug)
Expansion phase TAS-114 (PART 2)
The TAS-114 and S-1 MTD established in the Dose Escalation Phase will be administered BID for 14 days followed by a 7 day recovery period.
This regimen is repeated every 21 days thereafter. Approximately 40 to 60 evaluable patients will be enrolled in the Expansion Phase. PGx, PD and PK analysis will be performed based on specific criteria.
干预措施: TAS-114 (Drug)
Expansion phase TAS-114 (PART 2)
The TAS-114 and S-1 MTD established in the Dose Escalation Phase will be administered BID for 14 days followed by a 7 day recovery period.
This regimen is repeated every 21 days thereafter. Approximately 40 to 60 evaluable patients will be enrolled in the Expansion Phase. PGx, PD and PK analysis will be performed based on specific criteria.
干预措施: S-1 (Drug)
结局指标
主要结局
Identify Maximum Tolerated Dose (MTD) in mg/kg
时间窗: Up to 2.5 Years
To investigate the safety and determine the maximum tolerated dose (MTD) of TAS-114 in combination with S-1 in patients with advanced solid tumor(s) for which no standard therapy exists.
次要结局
未报告次要终点