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BN83495 Phase I in Post-menopausal Women

NCT01840488 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-11-22

No results posted yet for this study

Summary

The purpose of this study is to determine the optimal biological dose (OBD) of Irosustat (BN83495) in postmenopausal women with oestrogen receptor (ER) positive locally advanced or metastatic breast cancer with disease progression after prior hormonal therapy.

This study is designed to provide necessary information on safety and dose response of BN83495, when given by repeated once daily oral administration, while achieving a maximal STS inhibition and a maximal reduction in plasma oestradiol (E2) and adiol levels. The data obtained will be used to plan further clinical studies.

Conditions

Interventions

DRUG

Irosustat (BN83495)

Three parts (A, B \& C) open label, multiple cohort, dose escalation study with once daily administration of irosustat at 1, 5, 20, 40 and 80 mg. Patients treated in any cohort were not allowed to escalate to higher doses or be enrolled in another dosing cohort. Part A - Single oral daily dose for 7 days, Part B - Repeated oral daily dose for 28 days and Part C - Repeated oral daily administration until disease progression.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Oncology · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Belgium
  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT01840488 on ClinicalTrials.gov