A Phase 1b/2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor (AI) Versus AI Alone in Women With Metastatic Breast Cancer (MBC)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase Ib: Safety and tolerability of 2 dose levels of MEDI-573 combined with AI
The primary objective of the dose-evaluation phase is to evaluate the safety and tolerability of 3 dose levels of MEDI 573 in combination with an AI in subjects with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative MBC. Specific endpoints: number of subjects with AEs, SAEs, and DLTs.
5 months
Yes
Jennifer McDevitt, PharmD, Ph.D.
Study Director
MedImmune LLC
United States: Food and Drug Administration
CD-ON-MEDI-573-1030
NCT01446159
June 2011
August 2015
Name | Location |
---|---|
Research Site | Mesa, Arizona |
Research Site | Anaheim, California |
Research Site | Danbury, Connecticut |
Research Site | Boca Raton, Florida |
Research Site | Albany, Georgia |
Research Site | Bangor, Maine |
Research Site | Baltimore, Maryland |
Research Site | Beverly, Massachusetts |
Research Site | Battle Kreek, Michigan |
Research Site | Alexandria, Minnesota |
Research Site | Grand Island, Nebraska |
Research Site | Belleville, New Jersey |
Research Site | Albuquerque, New Mexico |
Research Site | Albany, New York |
Research Site | Akron, Ohio |
Research Site | Allentown, Pennsylvania |
Research Site | Chattanooga, Tennessee |
Research Site | Abilene, Texas |
Research Site | Abington, Virginia |