Status:
COMPLETED
Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
Lead Sponsor:
Eli Lilly and Company
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00698841
Start Date
February 1 2009
End Date
February 1 2010
Last Update
December 24 2015
Active Locations (16)
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1
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
2
Donald W. Hill, MD
Casa Grande, Arizona, United States, 85222
3
Compassionate Cancer Care Medical Group, Inc
Corona, California, United States, 92879
4
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, United States, 92708