A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications
Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.
No
MD
Study Director
Amgen
Belgium: Grand Hôpital de Charleroi comité d'éthique
20060517
NCT01281254
March 2011
June 2018
Name | Location |
---|---|
Research Site | Anaheim, California |
Research Site | Danbury, Connecticut |
Research Site | Boca Raton, Florida |
Research Site | Arlington Heights, Illinois |
Research Site | Alexandria, Minnesota |
Research Site | Albany, New York |
Research Site | Asheville, North Carolina |
Research Site | Bismarck, North Dakota |
Research Site | Allentown, Pennsylvania |
Research Site | Aberdeen, South Dakota |
Research Site | Abilene, Texas |
Research Site | Abington, Virginia |
Research Site | Appleton, Wisconsin |