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A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

Trial Profile

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Jun 2020

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At a glance

  • Drugs Olaparib (Primary)
  • Indications Adenocarcinoma; Pancreatic cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms POLO
  • Sponsors AstraZeneca
  • Most Recent Events

    • 01 Jun 2020 According to an AstraZeneca media release, based on the results from this Phase 3 (POLO) trial, the CHMP of the EMA has adopted a positive opinion, recommending LYNPARZA for approval as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2 mutations (gBRCAm) who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
    • 31 May 2020 Results presented at the 56th Annual Meeting of the American Society of Clinical Oncology
    • 31 May 2020 Results of an exploratory analysis assessing germline BRCA1 and BRCA2 mutations profiles in metastatic pancreatic cancer treated with Olaparib presented at the 56th Annual Meeting of the American Society of Clinical Oncology
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