NCT02471716

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

A Phase 1/2 Study of Cabiralizumab, an Anti-CSF1 Receptor Antibody, in Patients With Pigmented Villonodular Synovitis (PVNS)/ Diffuse Type Tenosynovial Giant Cell Tumor (Dt-TGCT)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Five Prime Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.

Detailed description

A Phase 1/2 study was an open-label, dose escalation and dose expansion study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of cabiralizumab, a CSF1-R monoclonal antibody, inpatients with unresectable diffuse tenosynovial giant cell tumors (TGCT).

Conditions

• Pigmented Villonodular Synovitis
• Tenosynovial Giant Cell Tumor

Interventions

Type	Name	Description
BIOLOGICAL	FPA008	FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks

Timeline

• Start date: 2015-06-01
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2015-06-15
• Last updated: 2021-08-31
• Results posted: 2021-08-31

Locations

12 sites across 6 countries: United States, France, Netherlands, Poland, South Korea, United Kingdom