A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects with Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath ENLIVEN

Trial Profile

A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects with Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath ENLIVEN

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2017

At a glance

  • Drugs Pexidartinib (Primary)
  • Indications Giant cell tumour of tendon sheath; Pigmented villonodular synovitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ENLIVEN
  • Sponsors Daiichi Sankyo Inc
  • Most Recent Events

    • 03 Nov 2016 This trial has been suspended in Spain.
    • 21 Oct 2016 According to Daiichi Sankyo media release, the ENLIVEN data monitoring committee (DMC) recommended that further enrollment into the study be suspended, however, the study will proceed with currently enrolled patients under a revised protocol.
    • 17 Oct 2016 Status changed from suspended to active, no longer recruiting.
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