Study of FPA008 in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 45
• Participant gender: Both

Summary

This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of FPA008 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Five Prime Therapeutics, Inc.
• Last Updated: 2016-09-13

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)

• CK and 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

• Positive test for latent TB at Screening (Quantiferon test)