Trials / Completed
CompletedNCT00910091
The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The Primary Objective in this study is to determine the antitumour efficacy of BN83495 measured by the percentage of women with advanced or recurrent endometrial cancer who have neither progressed nor died after 6 months of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2012-01-01
- Completion
- 2013-07-01
- First posted
- 2009-05-29
- Last updated
- 2019-01-30
- Results posted
- 2015-09-30
Locations
54 sites across 12 countries: Belgium, Czechia, France, Hungary, Latvia, Lithuania, Moldova, Poland, Russia, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00910091. Inclusion in this directory is not an endorsement.