Spots Global Cancer Trial Database for Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
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Trial Identification
Brief Title: Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
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)
Study ID: NCT02471716
Interventions
Study Description
Brief Summary: This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.
Detailed Description: A Phase 1/2 study was an open-label, dose escalation and dose expansion study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of cabiralizumab, a CSF1-R monoclonal antibody, inpatients with unresectable diffuse tenosynovial giant cell tumors (TGCT).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars-Sinai Medical Center, Los Angeles, California, United States
Sarcoma Oncology Research Center LLC, Santa Monica, California, United States
Stanford Medicine, Stanford, California, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest, Bordeaux, , France
Centre Léon Bérard, Lyon, , France
Seoul National University Hospital, Seoul, Jongno-gu, Korea, Republic of
Leiden University Medical Center, Leiden, , Netherlands
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Warsaw, , Poland
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
Oxford University Hospital NHS Trust, Oxford, , United Kingdom
Contact Details
Name: Medical Lead
Affiliation: Five Prime Therapeutics, Inc.
Role: STUDY_DIRECTOR
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