©2024 Stanford Medicine
Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
Not Recruiting
Trial ID: NCT02471716
Purpose
This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of
cabiralizumab in PVNS/dt-TGCT patients.
Official Title
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)
Stanford Investigator(s)
Kristen N Ganjoo
Professor of Medicine (Oncology)
Eligibility
Inclusion Criteria:
- Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
resectable tumor that would result in unacceptable functional loss or morbidity as
determined by a qualified surgeon or multi-disciplinary tumor board (must be
documented in the CRF during screening)
- Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI
- ECOG performance status <1
Exclusion Criteria:
- Prior therapy with an anti-CSF1R antibody
- Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
on prior kinase inhibitor)
- Liver function tests (including ALT, AST, and total bilirubin), outside of the range
of local laboratory normal at Screening
- Inadequate organ or bone marrow function
- History of congestive heart failure or myocardial infarction <1 year prior to first
study dose administration
- Significant abnormalities on ECG at Screening
- Contraindications to MRI and use of intravenous gadolinium-based contrast agents
- Creatine Kinase ≥ 1.5x the upper limit of normal
- Positive test for latent TB at Screening (Quantiferon test)
- Active known or suspected autoimmune disease
Intervention(s):
biological: FPA008
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061