A Phase I/II Study to Assess the Safety and Therapeutic Effect of INCB007839 in Combination With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.
Measured monthly starting at Baseline (estimated duration 6-9 months)
Yes
Denise A. Yardley, MD
Principal Investigator
Sara Cannon Research Institute
United States: Food and Drug Administration
INCB 7839-204
NCT01254136
October 2010
October 2011
Name | Location |
---|---|
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Flint, Michigan 48532 | |
Little Rock, Arkansas 72205-7199 | |
Hackensack, New Jersey 07601 | |
Denver, Colorado | |
Charlotte, North Carolina | |
Salt Lake City, Utah 84112 |