NCT01867866已完成1 期
A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone
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
- 44
- 试验地点
- 1
- 主要终点
- FTD pharmacokinetic parameters AUC0-last and Cmax
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.
详细描述
This is a Phase 1, open-label, randomized, parallel, 2-group study evaluating the PK of FTD as a TAS-102 component compared with FTD alone in patients with advanced solid tumors (excluding breast cancer). Patients will be randomized to receive a single dose of TAS-102 or FTD during the PK contribution phase and will receive continuing cycles of TAS-102 during the extension phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
- •ECOG performance status of 0 or 1
- •Is able to take medications orally
- •Has adequate organ function (bone marrow, kidney and liver)
- •Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
排除标准
- •Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
- •Certain serious illnesses or medical condition(s)
- •Has had either partial or total gastrectomy
- •Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- •Known sensitivity to TAS-102 or its components
- •Is a pregnant or lactating female
- •Refuses to use an adequate means of contraception (including male patients)
研究组 & 干预措施
TAS-102
Experimental
干预措施: TAS-102 (Drug)
FTD (Trifluridine)
Experimental
干预措施: Trifluridine (Drug)
结局指标
主要结局
FTD pharmacokinetic parameters AUC0-last and Cmax
时间窗: Day 1 of Cycle 1
次要结局
- FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F(Day 1 of Cycle 1)
- FTY and TPI pharmacokinetic parameters AUC0-last, Cmax, AUC0-inf, Tmax, T1/2, CL/F, and Vd/F(Day 1 of Cycle 1)
- Safety monitoring including adverse events, vital signs, and laboratory assessments(Through 30 days following last administration of study medication or until initiation of new anticancer treatment)
- Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)(Every 8 weeks through Cycle 6 (ie, through 24 weeks). Thereafter, assessments will be performed at least every 12 weeks according to site standard of care, until at least one of the treatment discontinuation criteria is met.)
- Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2(Day 12 of Cycles 1, 2, and 3)
研究者
研究点 (1)
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