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Trial record 2 of 4 for:    fpa008

Study of FPA008 in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

This study is currently recruiting participants.
Verified September 2016 by Five Prime Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02471716
First Posted: June 15, 2015
Last Update Posted: September 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.
  Purpose
This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of FPA008 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 Intervention Phase
Pigmented Villonodular Synovitis Tenosynovial Giant Cell Tumor Drug: FPA008 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of FPA008, an Anti-CSF1 Receptor Antibody, in Patients With Pigmented Villonodular Synovitis (PVNS)/ Diffuse Type Tenosynovial Giant Cell Tumor (Dt-TGCT)

Resource links provided by NLM:


Further study details as provided by Five Prime Therapeutics, Inc.:

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

Secondary Outcome Measures:
  • Composite PK parameters of FPA008: area under serum concentration-time curve (AUC), maximum serum concentration (Cmax), minimum serum concentration (Cmin), and clearance (CL); additional PK parameters as appropriate. [ Time Frame: 52 weeks ]
  • The incidence of AEs. [ Time Frame: 52 weeks ]
  • The incidence of clinical laboratory abnormalities. [ Time Frame: 52 weeks ]
  • The incidence of ECG abnormalities. [ Time Frame: 52 weeks ]
  • Duration of response per RECIST 1.1 [ Time Frame: 52 weeks ]

Estimated Enrollment: 45
Study Start Date: June 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: FPA008
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 weeks
Experimental: Phase 2 FPA008 Dose Expansion
IV infusion; once MTD and/or RD has been determined in Phase 1, an expansion cohort of approximately 30 patients 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.
Drug: FPA008
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  • CK and 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
  • Positive test for latent TB at Screening (Quantiferon test)
  Contacts and Locations
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


Contacts
Contact: Medical Lead FPA008002@fiveprime.com

Locations
United States, California
Sarcoma Oncology Research Center LLC Recruiting
Santa Monica, California, United States, 90403
Principal Investigator: Kamalesh Sankhala, MD         
Stanford Medicine Recruiting
Stanford, California, United States, 94301-5821
Principal Investigator: Kristen N Ganjoo, MD         
France
Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest Recruiting
Bordeaux, France, 33076
Principal Investigator: Italiano Antoine, MD         
Centre Léon Bérard Recruiting
Lyon, France, 69008
Principal Investigator: Blay Jean-Yves, MD         
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Jongno-gu, Korea, Republic of, 110-744
Principal Investigator: Tae Min Kim, MD         
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2333 ZA
Principal Investigator: Andre J Gelderblom, MD         
Poland
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie Recruiting
Warsaw, Poland, 02-781
Principal Investigator: Piotr Rutkowski, MD, PhD         
United Kingdom
Oxford University Hospital NHS Trust Recruiting
Oxfordshire, United Kingdom, OX3 7LE
Principal Investigator: Bass Hassan, MD, PhD         
Sponsors and Collaborators
Five Prime Therapeutics, Inc.
Investigators
Study Director: Medical Lead Five Prime Therapeutics, Inc.
  More Information

Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02471716     History of Changes
Other Study ID Numbers: FPA008-002
First Submitted: June 1, 2015
First Posted: June 15, 2015
Last Update Posted: September 15, 2016
Last Verified: September 2016

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

Additional relevant MeSH terms:
Synovitis
Giant Cell Tumors
Synovitis, Pigmented Villonodular
Joint Diseases
Musculoskeletal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms