FPA008-002_Study of FPA008 in joint disease (PVNS/dt-TGCT)
Research type
Research Study
Full 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 Tumour (dt-TGCT)
IRAS ID
179815
Contact name
Bass Hassan
Contact email
Sponsor organisation
Five Prime Therapeutics, Inc
Eudract number
2015-000574-17
Duration of Study in the UK
3 years, 1 months, 0 days
Research summary
Pigmented villonodular synovitis (PVNS) and diffuse-type Tenosynovial Giant Cell Tumour (dt-TGCT) are non-cancerous inflammations of the joint lining which lead to tumour growth. The main treatment option for patients is surgery. Tumour regrowth is likely which requires the patient to undergo more surgery. A treatment is required that does not require the patient to have repeated operations and a class of drugs called CSF1R inhibitors have shown some clinical benefit. The study drug, FPA008, is in this class of drugs. It is hoped that it will prove useful to patients where surgery is not an option or the patient no longer wishes to undergo more surgery. Patients enrolled into Phase 1 of the study will be given one of three dose levels. These doses will be given in order (dose escalation) and only when the previous dose is shown to be well-tolerated will the dosage increase. Phase 2 will take the most beneficial dose level from Phase 1 and test that in a group of patients. Phase 1 will enrol approximately 12-15 patients. Phase 2 will enrol approximately 30 patients. A patient will enrol into either Phase 1 or Phase 2. To be eligible for the study, patients must meet a variety of inclusion and exclusion criteria, be aged at least 18 years at the start of the study and be willing to consent and participate in the research. The research will be conducted at hospitals. The study will last for a maximum of 3 years and 6 months (Phase 1 and Phase 2). Participants in the research will undergo a variety of assessments including administration of the study drug, blood tests, MRI scans, ECGs and questionnaires. Participants will also have the option to consent into optional sampling which would require biopsies.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0381
Date of REC Opinion
2 Sep 2015
REC opinion
Further Information Favourable Opinion