NCT02874664已完成1 期
An Intensive QT/QTc Study to Investigate the Effects of Rovalpituzumab Tesirine on Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
Stemcentrx15 个研究点 分布在 2 个国家目标入组 46 人开始时间: 2016年9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
- 46
- 试验地点
- 15
- 主要终点
- Change in QTcF interval from baseline QTcF following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.
研究概览
简要总结
Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization in subjects with small cell lung cancer (SCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed extensive-stage small-cell lung cancer (SCLC).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Adequate hematologic and organ function as confirmed by laboratory values
排除标准
- •Clinically significant cardiac abnormalities including QRS duration of >120 msec; QTcF >470 msec for women and >450 msec for men; Abnormal cardiac rhythm; Clinically significant cardiac valve abnormality; Documented history of left ventricular ejection fraction <0.30 within 6 months; Permanent pacemaker or automatic implantable cardioverter defibrillator; History of torsades de pointes, congenital long QT syndrome, or family history of long QT syndrome or sudden death
- •Recent or ongoing serious infection
- •Women who are pregnant or breastfeeding
- •Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation.
研究组 & 干预措施
Rovalpituzumab Tesirine
Experimental
0.3 mg/kg rovalpituzumab tesirine intravenously on Day 1 of every 6-week treatment cycle for 2 cycles omitting every third cycle
干预措施: Rovalpituzumab Tesirine (Drug)
结局指标
主要结局
Change in QTcF interval from baseline QTcF following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.
时间窗: 12 weeks
次要结局
- Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.(12 weeks)
- Incidence of proarrhythmic adverse events stratified by change in QTcF from baseline of less than 10 ms or greater than 10 ms.(12 weeks)
- Progression free survival(Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.)
- Area Under the Curve (AUC)(Cycles 1 and 2: Day 1 (predose, 30 min, 2 and 4 hours postdose) and days 2,3,4,8,15,and 29; Cycles 4,5,7,8: Day 1 predose and 30 min postdose.)
- Change in QRS duration interval from baseline QRS duration following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.(12 weeks)
- Incidence of adverse events.(From first dose through 30 days post-last-dose)
- Clinical benefit ratio(Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.)
- Change in RR interval from baseline RR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.(12 weeks)
- Change in PR interval from baseline PR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.(12 weeks)
- Duration of response(Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.)
- Change in waveform composition interval from baseline waveform composition following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.(12 weeks)
- Objective response rate(Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.)
- Overall survival(Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.)
- Maximum Plasma Concentration (Cmax)(Cycles 1 and 2: Day 1 (predose, 30 min, 2 and 4 hours postdose) and days 2,3,4,8,15,and 29; Cycles 4,5,7,8: Day 1 predose and 30 min postdose.)
研究者
研究点 (15)
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