Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: ImClone LLC
• Treatments: Cetuximab

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