NCT01867879已完成1 期
A Phase 1 Study to Evaluate the Cardiac Safety of Orally Administered TAS-102 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
- 44
- 试验地点
- 1
- 主要终点
- QTc interval
研究概览
简要总结
The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors.
详细描述
This is a Phase 1, nonrandomized study to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors. The study is conducted in 2 phases: the cardiac safety evaluation phase to investigate cardiac repolarization and the cardiac safety profile (Cycle 1) and the extension phase to assess the safety profile and antitumor activity (subsequent cycles).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Has received no more than 5 prior cancer therapies
- •ECOG performance status of 0 or 1
- •Is able to take medications orally
- •Corrected QT interval using Bazett's correction is no more than 450 msec on resting ECG
- •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. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
- •Certain serious illnesses or medical condition(s)
- •Has a family history of unexplained sudden death or long QT syndrome
- •Has had a documented cardiovascular complication following a fluoropyrimidine-derived treatment
- •Is a patient for whom it is not technically possible to obtain quality ECG tracings
- •Is receiving a concomitant drug that is known to affect QT interval or to be arrhythmogenic
- •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)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
QTc interval
时间窗: Days -2, -1, 1, and 12 of Cycle 1
Predose (Day -2) to post-dose changes and absolute values in QTc interval after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1)
次要结局
- 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)
- Quantitative and Qualitative ECG parameters(Days -2, -1, 1, and 12 of Cycle 1)
- Relationship between TAS-102 pharmacokinetics and its effect on cardiac repolarization(Days 1 and 12 of Cycle 1)
- 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.)
研究者
研究点 (1)
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