Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With… (NCT00698841) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
United States79 participantsStarted 2009-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Advanced or metastatic malignant disease originating from solid tumors
* Adequate recovery from previous therapy or intervention; at least 21 days since major surgery or prior radiation therapy
* Measurable or evaluable disease
Exclusion criteria:
* Women of childbearing potential (WOCBP) who are breastfeeding, pregnant, or unwilling or unable to use acceptable contraception during the study and for at least 12 weeks after the last on-study dose of cetuximab
* Men unwilling to use acceptable contraception during the study if engaged in sexual relations with a WOCBP
* Symptomatic brain metastasis
* History of myocardial infarction 6 months or less prior to study entry, of severe congestive heart failure, of uncontrolled angina, or of uncontrolled arrhythmias
* Clinically relevant abnormality on screening electrocardiogram (ECG), preventing an accurate measurement of the QT interval
* Congenital long QT syndrome
* History of risk factors for ventricular tachycardia or Torsades de pointes or history of fainting, unexplained loss of consciousness, or convulsions
* Prolonged QTc interval on screening ECG (greater than 470 msec) using Fridericia's correction formula
* Heart rate slower than 50 bpm or faster than 100 bpm at rest during screening ECG measurements
* Implantable pacemaker or automatic implantable cardioverter defibrillator
* Sustained supine systolic blood pressure higher than 150 mmHg or lower than 90 mmHg or a diastolic blood pressure lower t…
What they're measuring
1
Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline
Timeframe: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
2
Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point
Timeframe: Predose Day 1 (Baseline) to end of Cycle 1 (28 days)