NCT03069469

Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

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 Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Deciphera Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label Phase 1/2 study of vimseltinib in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.

Conditions

• Advanced Malignant Neoplasm
• Pigmented Villonodular Synovitis
• Giant Cell Tumor of Tendon Sheath
• Tenosynovial Giant Cell Tumor
• Tenosynovial Giant Cell Tumor, Diffuse

Interventions

Type	Name	Description
DRUG	Vimseltinib	Colony-stimulating factor 1 receptor (CSF1R) inhibitor

Timeline

• Start date: 2017-02-16
• Primary completion: 2026-07-01
• Completion: 2028-08-01
• First posted: 2017-03-03
• Last updated: 2025-12-18

Locations

24 sites across 9 countries: United States, Australia, Canada, France, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study