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

Lilly

Status and phase

Completed

Phase 2

Conditions

Advanced Cancer

Treatments

Drug: Cetuximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00698841

CA225-315

Details and patient eligibility

About

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.

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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