A Study to Evaluate the Relationship Between Cetuximab Therapy and Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 15
- 主要终点
- Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline
研究概览
简要总结
The purpose of this study is to determine whether corrected QT (QTc) interval changes occur on an electrocardiogram (ECG) when cetuximab is administered to the study population.
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
Cetuximab
干预措施: Cetuximab (Drug)
结局指标
主要结局
Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline
时间窗: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The corrected QTc is the QT interval corrected for heart rate. Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion.
Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point
时间窗: Predose Day 1 (Baseline) to end of Cycle 1 (28 days)
The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The QTc is the QT interval corrected for heart rate. The QTcF=QT/RR\^1/3, where RR=RR interval in seconds. Baseline=predose. Mean change in QTc interval from baseline to time t=QTc interval at time t minus QTc interval at baseline.
次要结局
- Number of Participants With Death, Treatment-related Death, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs Leading to Discontinuation(Baseline through Cycle 1 (28 days), continuously)
- Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate(Baseline, Day 1, and then weekly to end of Cycle 1 (28 days))
- Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study(At screening, at the end of Cycle 1 (28 days))
- Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade(Baseline through Cycle 1 (28 days), continuously)
- Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)(At screening, at the end of Cycle 1 (28 days))
- Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study(At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up)