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Trial record 2 of 8 for:    FPA008

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor (FPA008-002)

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ClinicalTrials.gov Identifier: NCT02471716
Recruitment Status : Active, not recruiting
First Posted : June 15, 2015
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.

Brief Summary:
This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of Cabiralizumab 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.

Condition or disease Intervention/treatment Phase
Pigmented Villonodular Synovitis Tenosynovial Giant Cell Tumor Biological: FPA008 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Biological: FPA008
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
Other Name: Cabiralizumab

Experimental: 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.
Biological: FPA008
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
Other Name: Cabiralizumab




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

Secondary Outcome Measures :
  1. Composite PK parameters of cabiralizumab: area under serum concentration-time curve (AUC). [ Time Frame: 52 weeks ]
  2. Composite PK parameters of cabiralizumab: maximum serum concentration (Cmax). [ Time Frame: 52 weeks ]
  3. Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin). [ Time Frame: 52 weeks ]
  4. Composite PK parameters of cabiralizumab: clearance (CL). [ Time Frame: 52 weeks ]
  5. The incidence of AEs. [ Time Frame: 52 weeks ]
  6. The incidence of clinical laboratory abnormalities. [ Time Frame: 52 weeks ]
  7. The incidence of ECG abnormalities. [ Time Frame: 52 weeks ]
  8. Duration of response per RECIST 1.1 [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471716


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sarcoma Oncology Research Center LLC
Santa Monica, California, United States, 90403
Stanford Medicine
Stanford, California, United States, 94301-5821
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Texas
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
France
Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest
Bordeaux, France, 33076
Centre Léon Bérard
Lyon, France, 69008
Korea, Republic of
Seoul National University Hospital
Seoul, Jongno-gu, Korea, Republic of, 110-744
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Poland
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
Warsaw, Poland, 02-781
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Oxford University Hospital NHS Trust
Oxfordshire, United Kingdom, OX3 7LE
Sponsors and Collaborators
Five Prime Therapeutics, Inc.
Investigators
Study Director: Medical Lead Five Prime Therapeutics, Inc.

Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02471716     History of Changes
Other Study ID Numbers: FPA008-002
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: June 2018

Keywords provided by Five Prime Therapeutics, Inc.:
Diffuse Type Tenosynovial Giant Cell Tumor (dt-TGCT)

Additional relevant MeSH terms:
Synovitis
Giant Cell Tumors
Giant Cell Tumor of Tendon Sheath
Synovitis, Pigmented Villonodular
Joint Diseases
Musculoskeletal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Tendinopathy
Muscular Diseases