Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
Trial ID or NCT#
NCT02471716
Status
NOT RECRUITING
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)
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
