At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 73 enrolled
Drug / intervention
BN83495 +1 moredrug
Likely dose
BN83495 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II International Multicentre Randomised Open Label Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer
In Brief
A Phase 2 clinical trial evaluating BN83495 and Megestrol Acetate (MA) for Endometrial Cancer. Completed, enrolled 73 participants across 54 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Cancer
CountriesBelgium, Czechia, France, Hungary, Latvia, Lithuania, Moldova, Poland, Russia, Spain, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2009
Enrollment StartAug 2009
Primary CompletionJan 2012
Study CompletionJul 2013
TodayJul 2026
First PostedMay 29, 2009
Enrollment StartAug 1, 2009
Primary CompletionJan 1, 2012
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.1 years ago
Interventions
BN83495drug
BN83495 will be administered as a 40 mg tablet once a day orally
Megestrol Acetate (MA)drug
MA will be administered orally as 160mg daily