A Study to Evaluate the Relationship Between Cetuximab Therapy and Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors

Inclusion 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