NCT01078662

Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response

Conditions

• Ovarian
• Breast
• Prostate
• Pancreatic
• Advanced Tumours

Interventions

Type	Name	Description
DRUG	olaparib	Tablets Oral BID

Timeline

• Start date: 2010-02-21
• Primary completion: 2012-07-31
• Completion: 2024-08-12
• First posted: 2010-03-02
• Last updated: 2025-08-13
• Results posted: 2015-05-22

Locations

14 sites across 6 countries: United States, Australia, Germany, Israel, Spain, Sweden