Clinical trial · Interventional
Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
A Study to Evaluate the Relationship Between Cetuximab Therapy and Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
NCT00698841CI-TRIAL-00020320completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab
- interventionNames
- Drug: Cetuximab
Primary outcomes (2)
- measure
- 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)
- description
- 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.
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 than 45 mmHg or higher than 95 mmHg at screening * Known history of arterial thrombotic events within 6 months prior to study initiation * Known history of significant peripheral artery disease * Current participation in a clinical trial with another investigational new drug or device * Receipt of an investigational new drug or device within 21 days prior to enrollment in this study
References
Publications (1)
- DERIVEDDeeken JF, Shimkus B, Liem A, Hill D, Gurtler J, Berghorn E, Townes L, Lu H, Trifan O, Zhang S. Evaluation of the relationship between cetuximab therapy and corrected QT interval changes in patients with advanced malignancies from solid tumors. Cancer Chemother Pharmacol. 2013 Jun;71(6):1473-83. doi: 10.1007/s00280-013-2146-5. Epub 2013 Apr 16. PMID 23589315