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A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

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Trial Profile

A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 18 Aug 2025

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At a glance

  • Drugs Vimseltinib (Primary)
  • Indications Giant cell tumour of tendon sheath; Solid tumours
  • Focus Adverse reactions; First in man; Pharmacokinetics; Proof of concept; Therapeutic Use
  • Sponsors Deciphera Pharmaceuticals

Most Recent Events

  • 28 Jul 2025 According to Deciphera Pharmaceuticals media release, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of vimseltinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor, European Commission decision is expected in the second quarter of the fiscal year ending March 31, 26. The positive opinion is supported by results from this trail and the pivotal Phase 3 MOTION.
  • 06 Feb 2024 According to Deciphera Pharmaceuticals media release, the company expects to initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of chronic graft versus host disease (cGVHD) in the fourth quarter of 2024.
  • 08 Jan 2024 According to a Deciphera Pharmaceuticals media release, data from this trial will be presented in the second half of 2024.

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