A Study to Evaluate the Relationship Between Cetuximab Therapy and Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline
12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The corrected QTc is the QT interval corrected for heart rate. Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion.
Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
Yes
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA225-315
NCT00698841
February 2009
February 2010
Name | Location |
---|---|
Ocala Oncology Center | Ocala, Florida 34474 |
Pacific Shores Medical Group | Long Beach, California 90813 |
Georgetown University Medical Center | Washington, District of Columbia 20007 |
Compassionate Cancer Care Medical Group, Inc | Fountain Valley, California 92708 |
Cancer Specialists of Oklahoma | Oklahoma City, Oklahoma 73112 |
Baptist Cancer Institute | Jacksonville, Florida 32207 |
Northwest Alabama Cancer Center | Muscle Shoals, Alabama 35661 |
Austin Cancer Centers | Austin, Texas 78759 |
Pharma Resource | East Providence, Rhode Island 02915 |
Donald W. Hill, MD | Casa Grande, Arizona 85222 |
Compassionate Cancer Care Medical Group Inc | Fountain Valley, California 92708 |
Desert Hospital Comprehensive Cancer Center | Palm Springs, California 92262 |
American Institute Research | Whittier, California 90603 |
Brinz, Burroff, Gurtler, & Russo | Metairie, Louisiana 70006 |