Conditions: Endometrial Cancer
Keywords: Endometrial cancer Antitumour efficacy in women with advanced endometrial cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 73
Healthy volunteers: no

Brief 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.

Arms:
arm 1: After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service arm 2: After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service

Interventions: intervention 1: BN83495 intervention 2: Megestrol Acetate (MA)
Intervention descriptions: intervention 1: BN83495 will be administered as a 40 mg tablet once a day orally intervention 2: MA will be administered orally as 160mg daily

Protocol document: