The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer
NCT00910091 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2019-01-30
Summary
This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA) on progression free survival (PFS) in post menopausal patients with endometrial cancer.
Conditions
Interventions
- DRUG
-
BN83495
BN83495 will be administered as a 40 mg tablet once a day orally
- DRUG
-
Megestrol Acetate (MA)
MA will be administered orally as 160mg daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Ipsen Medical Director · Ipsen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2012-01-31
- Completion
- 2013-07-31
Countries
- Belgium
- Czechia
- France
- Hungary
- Latvia
- Lithuania
- Moldova
- Poland
- Russia
- Spain
- Ukraine
- United Kingdom
Study Locations
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