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

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