Expired Study
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Boston, Massachusetts 02215


Purpose:

This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of Cabiralizumab in PVNS/dt-TGCT patients. Patients will be enrolled into either Phase 1 (dose escalation) or Phase 2 (dose expansion) of the study, but not both.


Criteria:

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


NCT ID:

NCT02471716


Primary Contact:

Study Director
Medical Lead
Five Prime Therapeutics, Inc.


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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