QT-Cab: An Open-Label Study to Investigate the Effect of Cabazitaxel on the QTc Interval in Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 45
- 试验地点
- 15
- 主要终点
- Change from baseline in QT interval corrected calculation by Fridericia method
研究概览
简要总结
Primary Objective:
- To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients
Secondary Objectives:
- To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals
- To assess the clinical safety of cabazitaxel
- To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)
详细描述
The main period of the study consists of a maximum of 21-day screening phase, then first 2 treatment cycles with cabazitaxel. End of main period will be Cycle 3 or 30 days after last dose if patient discontinues study after 1 or 2 treatment cycles. The duration for a patient for the main period of the study will be about 9 to 10 weeks (screening, 2 cycles).
After Cycle 2, patients will have the option to continue to receive cabazitaxel and should be followed for safety reporting until 30 days after the last dose of cabazitaxel.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
cabazitaxel
At every cycle (every 3 weeks), on Day 1, patients will receive cabazitaxel, administered by intravenous (IV) infusion over 1 hour, at 25 mg/m2.
An IV premedication regimen composed of up to 4 treatments (antihistamine, corticosteroids, H2 antagonist other than cimetidine at all cycles, plus palonosetron at cycle 1) will be administered before cabazitaxel infusion.
干预措施: Cabazitaxel (XRP6258) (Drug)
结局指标
主要结局
Change from baseline in QT interval corrected calculation by Fridericia method
时间窗: Cycle 1, Day 1
次要结局
- Change from baseline in Heart rate, QT, QTcB (QT interval corrected calculation by Bazett method) and QTcN (QT interval with a population-specific correction formulae) intervals(Cycle 1, Day 1)
- Other ECG parameters : PR, QRS intervals and ECG morphology(Cycle 1, Day 1)
- Cabazitaxel plasma concentrations, Cmax and partial AUC -(Cycle 1, Day 1)
- Clinical safety based on adverse events, serious adverse event, laboratory assessments according to the National Cancer Institute- Common Terminology Criteria for Adverse Events v4.0 grade scaling(up to treatment discontinuation + 30 days over a maximum study period of 20 months)