Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 19
- 试验地点
- 7
- 主要终点
- Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)
研究概览
简要总结
This is an open-label study in which oprelvekin will be administered for the prevention of severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side effect of blocking your bone marrow from making platelet cells. The purpose of this study is to learn more about the effects of the recommended dose of oprelvekin on the heart's electrical cycle.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women must be 18 to 65 years of age, with nonmyeloid malignancies for whom oprelvekin is indicated.
- •At least one documented occasion of adequate hematologic recovery from previous or current chemotherapy.
- •Adequate renal and hepatic excretory function.
排除标准
- •A marked baseline prolongation of QT/QTc interval (eg, repeated [two out of three readings] demonstration of a QTcF interval >450 msec.
- •Additional risk factors for torsades de pointes including heart failure (subjects that have functional class III or IV congestive heart failure), hypokalemia, hypomagnesemia, or hypocalcemia.
- •A pace maker or defibrillator.
- •A history of LQTS, syncope, seizure, or the unexplained cardiac-related death of a family member at less than 30 years of age.
- •Requirement of concomitant prescription or non-prescription medications or dietary supplements that have a risk of causing torsades de pointes or prolonged QT/QTc interval.
研究组 & 干预措施
Oprelvekin as subcutaneous injection (50 mg/kg once daily)
Open label treatment with oprelvekin
干预措施: oprelvekin (Drug)
结局指标
主要结局
Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)
时间窗: Postdose Day 1 to end of treatment
Because the sponsor terminated the study prematurely, this population-specific correction of QT was not done. QT data collected during the study corrected using the Bazett's and Fridericia formulae are presented as secondary outcome measures.
次要结局
- Number of Participants With Time-matched Change From Baseline in Corrected QT (QTc) Interval ≥30 or 60 Msec Using Fridericia's (QTcF) and Bazett's (QTcB) Correction Formulas(Postdose Day 1 to end of treatment)
- Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas(Postdose Day 1 to end of treatment)