A Randomized, Partially-Blind, Placebo-Controlled, 2-Period Crossover Study to Assess the Effects of a Single Dose of Vorinostat on the QTc Interval in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Change From Baseline in QTcF at 3 Hours
研究概览
简要总结
A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.
详细描述
Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patient has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy or for which standard therapy does not exist
- •Patient has life expectancy of greater than 3 months
- •Patient is able to swallow capsules
排除标准
- •Patient has had chemotherapy, radiotherapy or biological therapy 2 weeks prior to taking study drug
- •Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
- •Patient has active CNS metastases and/or carcinomatous meningitis
- •Patient has primary central nervous system tumor
- •Patient has a history of drug or alcohol abuse
- •Patient has Hepatitis B or C
- •Patient is HIV positive
- •Patient has active infection or has received intravenous antibiotics, antiviral or antifungal agents 2 weeks before taking study drug
研究组 & 干预措施
A
Arm A: Drug/Placebo
干预措施: vorinostat (Drug)
B
Arm B: Placebo/Drug
干预措施: vorinostat (Drug)
结局指标
主要结局
Change From Baseline in QTcF at 3 Hours
时间窗: Baseline and 3 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 4 Hours
时间窗: Baseline and 4 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint.
Change From Baseline in QTcF at 24 Hours
时间窗: Baseline and 24 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 0.5 Hours
时间窗: Baseline and 0.5 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 1 Hour
时间窗: Baseline and 1 hour
Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 2 Hours
时间窗: Baseline and 2 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 12 Hours
时间窗: Baseline and 12 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 8 Hours
时间窗: Baseline and 8 hours
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
次要结局
未报告次要终点