Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization (QTc Duration) in Patients With Selected Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 16
- 主要终点
- Change in QTcF (QT Corrected According to Fridericia's Formula)
研究概览
简要总结
Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in patients with selected solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed and dated informed consent
- •Normal cardiac conduction and function (centrally read)
- •Blood pressure between 90 and 150 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic.
- •Specific serum electrolyte levels
排除标准
- •Age > 65 years
- •Performance status = 2 [Eastern Cooperative Oncology Group (ECOG)]
- •Heart rhythm disturbances
- •Significant ischemic coronary disease, heart failure, myocardial infarction, or unstable angina within the last six months.
- •Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) > 450 mg/m²
研究组 & 干预措施
A (lurbinectedin)
lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
干预措施: lurbinectedin (PM01183) (Drug)
结局指标
主要结局
Change in QTcF (QT Corrected According to Fridericia's Formula)
时间窗: Scheduled post-baseline ECG time points were taken 5-10 min before their time-matched PK samples: i.e., 5 min before EOI, 30 min, 1, 3, 24, 72 and 168 hours after EOI of Cycle 1, and 5 min before EOI, 30 min, 1, 3 and 168 hours after EOI of Cycle 2.
ΔQTCF (Change in QTcF); EOI (end of infusion); LSM (Least Square Means); PK (Pharmacokinetic(s)). On Day 1 (D1) of Cycle 1 (C1), LSM ΔQTcF should have low difference values, without any clear trend to change with time. Therefore, the upper bound (UB) of the (two-sided) 90%Confidence Interval (CI) at all time points had to be less than the protocol-specified cut-off of 20 ms at each time point. If so, non-inferiority of any ECG time point to baseline with respect of QTc prolongation could be concluded
次要结局
- Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Plasma Concentration)(Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks))
- Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Predicted ΔQTcF)(Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks))
- Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Intercept)(Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks))