INCB54828-209 (FIGHT-209)
Research type
Research Study
Full title
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1 3 Alterations (FIGHT-209)
IRAS ID
1004984
Contact name
Manuela Stoddart
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2021-004740-24
Clinicaltrials.gov Identifier
Research summary
This open-label, single arm, multicentre study consists of 3 cohorts (A, B and C). Study participants will be enrolled in one of these cohorts depending on their disease. The Study drug pemigatinib (INCB054828 and also known as Pemazyre) is an investigational drug, studied by Incyte Corporation and will be administered over a 3-week period cycles.
The purpose of this Study is to assess and determine the efficacy of pemigatinib in participants with recurrent Glioblastoma (GBM) (an aggressive type of cancer that can occur in the brain) or other CNS tumours with changes in the FGFR1, FGFR2 or FGFR3 genes.
There are four FGFR (fibroblast growth factor receptor) genes called FGFR1, FGFR2, FGFR3 and FGFR4; every person has FGFR genes in the body. Pemigatinib blocks 3 FGFR genes (FGFR1/2/3), so called receptors. By blocking these receptors, the study drug has the potential to stop the growth of the tumour.
Participants will receive the study drug once a day, every day, by mouth for 2 consecutive weeks followed by 1 week off-therapy. The study drug will be available in strengths of 4.5, 9, and 13.5 mg tablets. The starting dose will be 13.5 mg. There is no difference in the treatment regimen between the cohorts.
Participants will continue to receive study drug for as long as they are receiving benefit and have not met any criteria for study withdrawal. There will be 30 to 35 days for follow-up after the last dose of study drug. Afterwards, the follow-up will be every 8 weeks to collect survival data.
Upon completion of this study, for participants who are continuing to receive study drug and benefiting from treatment with pemigatinib, the rollover study, INCB 54828-801, is available.
Approx. 75 sites in 9 countries, to enrol around 189 patients. Patients will be aged 18 or older at the time of signing the ICF.
Planned recruitment end date is January 2024 and study end date is planned for Oct 2024.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0050
Date of REC Opinion
7 Apr 2022
REC opinion
Further Information Favourable Opinion