Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens

Trial Profile

Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Apr 2018

At a glance

  • Drugs Olaparib (Primary)
  • Indications Ovarian cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors AstraZeneca
  • Most Recent Events

    • 20 Mar 2018 Planned End Date changed from 29 Dec 2017 to 28 Dec 2018.
    • 23 Feb 2018 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a marketing authorization of LYNPARZA (olaparib) tablets for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, recommendation is based on SOLO-2 and Study19 trials.
    • 19 Jan 2018 According to an AstraZeneca media release, based on the data from Study 19 and SOLO-2 trial Japanese Ministry of Health, Labour and Welfare (JMHLW) has granted approval for LYNPARZA tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy.
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