NL-OMON40461已完成不适用
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 - M12-020
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AbbVie B.V.
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 sysptoms.
- •- 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.
- •- Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics
- •Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or
- •study-specific procedures.
排除标准
- •- Subject has a screening or baseline (pre-dose on Day 1 of Period 1 at approximately 8 - 10 AM) corrected QT interval (QTc) interval by Fridericia's correction (QTcF) > 470 ms.
- •- Uncorrected serum potassium, serum magnesium, serum calcium or free thyroxine (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 including:
- •PR interval > 220 ms or < 115 ms;
- •evidence of second or third degree atrioventricular (AV) block;
- •evidence of ventricular pre-excitation;
- •intraventricular conduction delay with QRS duration > 136 ms;
- •bradycardia as defined by sinus rate < 47 bpm.
- •- Subject has a significant history of cardiovascular disease including congenital long-QT syndrome, angina, myocardial ischemia or infarction, thrombotic or thromboembolic event in the last 6 months, myocarditis, angina on exertion, uncorrected hypocalcemia (<= 8.2 mg/dL), idiopathic cardiomyopathy, amyloid, tumor, sarcoid, scleroderma, syncope, epilepsy, hypertonic cardiomyopathy, or other clinically significant cardiac disease or baseline ECG abnormalities that could potentially confound subsequent analyses.
- •- 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.
研究者
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