Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance
Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients with a
Complete or Partial Response Following Platinum based Chemotherapy
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 (using blinded independent central review) according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Study data collection expected to last until 2018.
Professor E Pujade-Lauraine, MD, PhD
Universite de Paris Descartes, France
Australia: National Health and Medical Research Council