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

Completed · Phase 2

Conditions studied: Advanced Cancer

In brief

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.

Key facts

Study ID

NCT00698841

Run by

Eli Lilly and Company

People needed

79

Starts

2009-02-01

Expected to finish

2010-02-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwest Alabama Cancer Center — Muscle Shoals, Alabama, United States
• Donald W. Hill, MD — Casa Grande, Arizona, United States
• Compassionate Cancer Care Medical Group, Inc — Corona, California, United States
• Compassionate Cancer Care Medical Group Inc — Fountain Valley, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Desert Hospital Comprehensive Cancer Center — Palm Springs, California, United States
• Compassionate Cancer Care Medical Group, Inc — Riverside, California, United States
• American Institute Research — Whittier, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Brinz, Burroff, Gurtler, & Russo — Metairie, Louisiana, United States
• Cancer Specialists Of Oklahoma — Oklahoma City, Oklahoma, United States
• Pharma Resource — East Providence, Rhode Island, United States
• Austin Cancer Centers — Austin, Texas, United States
• Local Institution — San Juan, Pr, Puerto Rico

Full record on ClinicalTrials.gov

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