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A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With Platinum Sensitive Relapsed Ovarian Cancer Who Are in Complete or Partial Response Following Platinum Based Chemotherapy and Whose Tumours Carry Loss of Function Somatic BRCA Mutation(s) or Loss of Function Mutation(s) in Tumour Homologous Recombination Repair -Associated Genes

Trial Profile

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With Platinum Sensitive Relapsed Ovarian Cancer Who Are in Complete or Partial Response Following Platinum Based Chemotherapy and Whose Tumours Carry Loss of Function Somatic BRCA Mutation(s) or Loss of Function Mutation(s) in Tumour Homologous Recombination Repair -Associated Genes

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

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

    • 29 Apr 2016 Status changed from not yet recruiting to withdrawn prior to enrolment as this study is unlikely to be feasible given the evolving ovarian cancer landscape and alternative studies have the potential to meet future clinical demand.
    • 08 Feb 2016 Planned End Date changed from 1 Jan 2019 to 1 Jun 2019 as reported by ClinicalTrials.gov record.
    • 08 Feb 2016 Planned primary completion date changed from 1 Jan 2019 to 1 Jun 2019 as reported by ClinicalTrials.gov record.
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