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

Completed · Phase 1/Phase 2

Conditions studied: Pigmented Villonodular Synovitis, Tenosynovial Giant Cell Tumor

In brief

This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.

Key facts

Study ID

NCT02471716

Run by

Five Prime Therapeutics, Inc.

People needed

66

Starts

2015-06-01

Expected to finish

2020-04-30

Last updated by the study team

2021-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Leiden University Medical Center — Leiden, Netherlands
• Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie — Warsaw, Poland
• Seoul National University Hospital — Seoul, Jongno-gu, South Korea
• University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom
• Oxford University Hospital NHS Trust — Oxford, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.