A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib
Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian
Cancer following First Line Platinum Based Chemotherapy.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression Free Survival (PFS) by central review of RECIST data
To determine the efficacy by progression free survival (PFS) using blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.
Radiologic scans performed at baseline then every ~12 weeks for ~2 years, then every ~24 weeks thereafter until objective radiological disease progression. Study data collection expected to last for ~7 years.
No
Prof Paul DiSilvestro, MD
Principal Investigator
Women & Infants Hospital, Providence, Rhode Island, USA
Australia: National Health and Medical Research Council
D0818C00001
NCT01844986
July 2013
January 2022
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