At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 54 enrolled
Drug / intervention
Olaparibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open-label, Non-comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU-0059436 Given Orally Twice Daily in Patients With Advanced BRCA1- or BRCA2-associated Breast Cancer.
In Brief
A Phase 2 clinical trial evaluating Olaparib for Breast Neoplasms. Completed, enrolled 54 participants across 17 sites in 8 countries.
Detailed Summary
The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (BRCA)1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesAustralia, Canada, Germany, Israel, Spain, Sweden, United Kingdom, United States
CollaboratorsKuDOS Pharmaceuticals Limited
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJun 2007
Primary CompletionFeb 2009
Study CompletionDec 2022
TodayJul 2026
First PostedJun 29, 2007
Enrollment StartJun 15, 2007
Primary CompletionFeb 27, 2009
Study CompletionDec 21, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.0 years ago
Interventions
Olaparibdrug
Participants will receive capsules of olaparib orally as stated in arm description.