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Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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)

NCT02471716•Five Prime Therapeutics, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (12)

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

Key Dates

Start Date

June 1, 2015

Primary Completion Date

April 30, 2020

Completion Date

April 30, 2020

Last Updated

August 31, 2021

Enrollment

ACTUAL participants

Conditions

Pigmented Villonodular SynovitisTenosynovial Giant Cell Tumor

Interventions

FPA008

BIOLOGICAL

A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment

NCT04635111

HepatotoxicityTenosynovial Giant Cell Tumor

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

NCT03069469

Advanced Malignant NeoplasmPigmented Villonodular Synovitis+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment

Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT

An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee

Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT)