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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1/2 Study of FPA008, an Anti-CSF1 Receptor Antibody, in Patients With Pigmented Villonodular Synovitis (PVNS)/ Diffuse Type Tenosynovial Gian

Brief 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.

Detailed Summary:
Sponsor: Five Prime Therapeutics, Inc.

Current Primary Outcome:

  • The incidence of Grade 3 and Grade 4 adverse events (AEs) defined as dose-limiting toxicities (Phase 1) [ Time Frame: 52 weeks ]
  • The incidence of clinical laboratory abnormalities defined as dose-limiting toxicities (Phase 1) [ Time Frame: 52 weeks ]
  • The incidence of confirmed objective responses per RECIST 1.1 (Phase 2) [ Time Frame: 52 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Composite PK parameters of FPA008: area under serum concentration-time curve (AUC), maximum serum concentration (Cmax), minimum serum concentration (Cmin), and clearance (CL); additional PK parameters as appropriate. [ Time Frame: 52 weeks ]
  • The incidence of AEs. [ Time Frame: 52 weeks ]
  • The incidence of clinical laboratory abnormalities. [ Time Frame: 52 weeks ]
  • The incidence of ECG abnormalities. [ Time Frame: 52 weeks ]
  • Duration of response per RECIST 1.1 [ Time Frame: 52 weeks ]


Original Secondary Outcome:

  • Composite PK parameters of FPA008: area under serum concentration-time curve (AUC), maximum serum concentration (Cmax), minimum serum concentration (Cmin), and clearance (CL); additional PK parameters as appropriate. [ Time Frame: 10 weeks ]
  • The incidence of AEs. [ Time Frame: 52 weeks ]
  • The incidence of clinical laboratory abnormalities. [ Time Frame: 52 weeks ]
  • The incidence of retinal findings and ECG abnormalities. [ Time Frame: 52 weeks ]
  • Duration of response per RECIST 1.1 [ Time Frame: 52 weeks ]


Information By: Five Prime Therapeutics, Inc.

Dates:
Date Received: June 1, 2015
Date Started: June 2015
Date Completion: October 2018
Last Updated: September 13, 2016
Last Verified: September 2016