Phase 2
Completed N=51
Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
Source: ClinicalTrials.gov NCT00698841 ↗Enrolled (actual)
51
Serious AEs
31.4%
Results posted
May 2011
Primary outcomePrimary: Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline |
— | — |
| PRIMARY Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point |
3.8; 1.8; 0.7; 1.2; -2.4; 1.3 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate |
0; 0; 0 | — |
| SECONDARY 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 |
6; 0; 16; 2; 10; 3 | — |
| SECONDARY Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade |
6; 2; 0; 32; 1; 0 | — |
| SECONDARY Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study |
18; 27; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) |
0; 7; 15; 2; 0; 0 | — |
| SECONDARY Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study |
35; 34; 1; 2; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00698841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.