Phase 3 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

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2013
INTERVENTION: investigational material(s) Generic name etc : Olaparib 300mg tablets INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Taken orally twice daily control material(s) Generic name etc : Placebo to match olaparib 300mg INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Taken orally twice daily CONDITION: BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy INCLUSION CRITERIA: ‐Patients must be 18 years of age or more. >Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer. >Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). >who have received at least 2 previous lines of platinum containing therapy prior to randomisation For the penultimate chemotherapy course prior to enrolment on the study: ‐Patients defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy For the last chemotherapy course immediately prior to randomisation on the study: ‐Patients must be, in the opinion of the investigator, in response (partial or comp
Epistemonikos ID: 04e6b93c16b930d382a23f046ff02efb15b897e5
First added on: Aug 26, 2024