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A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)

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Trial Profile

A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)

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

Latest Information Update: 28 Feb 2025

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At a glance

  • Drugs Vimseltinib (Primary)
  • Indications Giant cell tumour of tendon sheath
  • Focus Registrational; Therapeutic Use
  • Acronyms MOTION
  • Sponsors Deciphera Pharmaceuticals

Most Recent Events

  • 24 Feb 2025 Study design has been amended (Crossover has been implemented ).
  • 14 Feb 2025 According to an Ono Pharmaceutical media release,company announced that the U.S. Food and Drug Administration (FDA) has approved ROMVIMZA (vimseltinib), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity based on this trial
  • 15 Aug 2024 According to an Ono Pharmaceutical media release, the U.S. Food and Drug Administration (FDA) accepted a priority review for the New Drug Application (NDA) on August 14 US time for vimseltinibfor the treatment of patients with tenosynovial giant cell tumor (TGCT), which is under development by Deciphera Pharmaceuticals, Inc..The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 17, 2025.

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