Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
NCT ID: NCT02471716
Last Updated: 2021-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
66 participants
INTERVENTIONAL
2015-06-30
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1 FPA008 Dose Escalation
IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. RD will be the maximum tolerated dose or lower dose that provide adequate PK exposure and biologic activity with tolerability.
FPA008
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
Phase 2 FPA008 Dose Expansion
IV infusion; once MTD and/or RD has been determined in Phase 1, expansion cohorts of approximately 30 patients (each cohort) with PVNS or dt-TGCT will be enrolled to characterize clinical activity and safety profile of the RD. Treatment is planned to continue for up to 24 weeks or 56 weeks.
FPA008
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
Interventions
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FPA008
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI
* ECOG performance status \<1
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Five Prime Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Lead
Role: STUDY_DIRECTOR
Five Prime Therapeutics, Inc.
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FPA008-002
Identifier Type: -
Identifier Source: org_study_id
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