A Phase II, International, Multicenter, Open-label, Proof of Concept Study of BN83495 in Postmenopausal Women With Advanced, Metastatic or Recurrent Oestrogen Receptor (ER) Positive Endometrial Carcinoma Who Have Received One Line of Chemotherapy in the Adjuvant or Metastatic Setting.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of clinical benefit (CB), defined as sum of patients who present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 weeks (CB=CR+PR+SD≥12 weeks) using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)
12 weeks
No
Anne Kornowski, MD
Study Director
Ipsen
United States: Food and Drug Administration
X-52-58064-007
NCT01251354
November 2010
July 2011
Name | Location |
---|---|
Dept of Obstetrics and Gynecology, Medical College of Georgia | Augusta, Georgia 30912 |
Division of Gynecologic Oncology, University of Minnesota Medical Center | Minneapolis, Minnesota 55455 |
Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Crozer Chester medical Center | Upland, Pennsylvania 19103 |