At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 66 enrolled
Drug / intervention
FPA008biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating FPA008 for Pigmented Villonodular Synovitis and Tenosynovial Giant Cell Tumor. Completed, enrolled 66 participants across 12 sites in 6 countries.
Detailed Summary
This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Netherlands, Poland, South Korea, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJun 2015
Primary CompletionApr 2020
TodayJul 2026
First PostedJun 15, 2015
Enrollment StartJun 1, 2015
Primary CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 11.0 years ago
Interventions
FPA008biological
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks