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An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Trial Profile

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

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

Latest Information Update: 06 Dec 2019

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At a glance

  • Drugs Avapritinib (Primary) ; Regorafenib
  • Indications Gastrointestinal stromal tumours
  • Focus Registrational; Therapeutic Use
  • Acronyms VOYAGER
  • Sponsors Blueprint Medicines
  • Most Recent Events

    • 05 Nov 2019 Status changed from recruiting to active, no longer recruiting, according to a Blueprint Medicines media release.
    • 05 Nov 2019 According to a Blueprint Medicines media release, based on the top-line data of this study, the PDUFA action date for PDGFRA Exon 18 mutant GIST and for fourth-line GIST is February 14, 2020.
    • 28 Oct 2019 According to a Blueprint Medicines media release, the company has completed patient screening in this trial and expects to complete patient enrollment by the end of November 2019.Blueprint Medicines plans to prioritize completion of the VOYAGER trial and delay initiation of its COMPASS-2L trial in second-line GIST. Subject to an initial approval of avapritinib, Blueprint Medicines plans to submit a supplemental NDA to the FDA for avapritinib for third-line GIST in the second half of 2020.
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