NCT02009631已完成1 期
A Randomized, Placebo-Controlled Crossover Study to Evaluate the Effect of Veliparib (ABT-888) on Cardiac Repolarization in Subjects With Relapsed or Refractory Solid Tumors
AbbVie5 个研究点 分布在 3 个国家目标入组 45 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- To evaluate the effect of Veliparib on corrected QT interval calculated by Fridericia's formula (QTcF)
研究概览
简要总结
This is a randomized Phase 1 study to evaluate the effects of Veliparib on cardiac repolarization in patients with solid tumors who's cancer has recurred or is no longer responding to current treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed solid malignancy that is metastatic or unresectable for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
- •Subjects with brain metastases must have clinically controlled neurologic symptoms.
- •Subject is able to swallow and retain oral medications and does not have uncontrolled emesis.
- •Subject has adequate bone marrow, renal and hepatic function per local laboratory reference ranges.
排除标准
- •Uncorrected serum potassium, serum magnesium, serum calcium or free thyroxin (FT4) and thyroid stimulating hormone (TSH) outside of normal reference ranges, or grade 2 hyponatremia or hypernatremia.
- •Subject has severe ECG morphologic abnormalities that make QTc evaluation difficult.
- •Subject has a history of cardiac conduction abnormalities.
- •Subject has a significant history of cardiovascular disease.
- •Subject has received any anti-cancer therapies 21 days prior to the first dose of study drug, or has recovered to no better than a grade 2 or higher clinically significant adverse effect(s)/toxicity(s) of the previous therapy.
- •Use of drugs with a known risk for QT prolongation and Torsades de Pointes within 7 days prior to the first study dose.
- •Use of tobacco or nicotine-containing products within 12 hours prior to the first study dose.
研究组 & 干预措施
Sequence Group A
Experimental
200 mg Veliparib
干预措施: Veliparib (ABT-888) (Drug)
Sequence Group B
Experimental
400 mg Veliparib
干预措施: Veliparib (ABT-888) (Drug)
Sequence Group C
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the effect of Veliparib on corrected QT interval calculated by Fridericia's formula (QTcF)
时间窗: Electrocardiograms (ECGs) will be done at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 in triplicate, 1 time point on Day 2 of Periods 1, 2, and 3 and 1 time point on Day 3 of Period 3.
次要结局
- Pharmacokinetic sampling maximum observed plasma concentration (Cmax)(Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.)
- Pharmacokinetic sampling - time to maximum observed plasma concentration (Tmax)(Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.)
- Pharmacokinetic sampling - the area under the plasma concentration-time curve (AUC) from time 0-24 hours (AUC 0-24)(Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.)
- The number of subjects with adverse events(Up to 30 days after last dose of study drug.)
- Vital Signs(Up to 30 days after last dose of study drug.)
- Clinical Laboratory Tests(Up to 30 days after last dose of study drug.)
- Tumor Assessment(Screening)
研究者
研究点 (5)
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