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

Study results available
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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

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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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00910091 on ClinicalTrials.gov