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 States, Puerto Rico79 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 range
18 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)