Open label study to assess efficacy and safety of Olaparib in confirmed genetic BRCA1 or BRCA2 mutation pats

Study identifier:D0810C00042

ClinicalTrials.gov identifier:NCT01078662

EudraCT identifier:2010-022278-15

CTIS identifier:N/A

Study Complete

Official Title

A Phase II, Open label, Non randomised, Non comparative, Multicentre study to assess the efficacy and safety of olaparib given orally twice daily in patients with advanced cancers who have a confirmed genetic BRCA 1 and/or BRCA2 mutation

Medical condition

ovarian

Phase

Phase 2

Healthy volunteers

No

Study drug

olaparib

Sex

All

Actual Enrollment

298

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 21 Feb 2010
Primary Completion Date: 31 Jul 2012
Study Completion Date: 12 Aug 2024

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria