At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 279 enrolled
Drug / intervention
Olaparibdrug
Likely dose
Olaparib 300 mgfrom 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 IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non-Germline BRCA Mutated Ovarian Cancer Patients Who Are in Complete or Partial Response Following Platinum Based Chemotherapy
In Brief
A Phase 3 clinical trial evaluating Olaparib for Non-Germline BRCA Mutated Ovarian Cancer. Completed, enrolled 279 participants across 91 sites in 19 countries.
Detailed Summary
The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Germline BRCA Mutated Ovarian Cancer
CountriesAustria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, United Kingdom
CollaboratorsIQVIA Pty Ltd, Myriad Genetics, Inc., Covance, Theradex, Parexel
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartJan 2018
Primary CompletionOct 2020
Study CompletionMar 2022
TodayJul 2026
First PostedJan 18, 2018
Enrollment StartJan 30, 2018
Primary CompletionOct 2, 2020
Study CompletionMar 10, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.5 years ago
Interventions
Olaparibdrug
300 mg twice daily - oral