Journal article
Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: A multicenter, openlabel, phase Ib/II trial
MI de la Fuente, H Colman, M Rosenthal, BA Van Tine, D Levacic, T Walbert, HK Gan, M Vieito, MM Milhem, K Lipford, S Forsyth, SM Guichard, Y Mikhailov, A Sedkov, J Brevard, PF Kelly, H Mohamed, V Monga
Neuro Oncology | Published : 2023
Abstract
Background: Olutasidenib (FT-2102) is a highly potent, orally bioavailable, brain-penetrant and selective inhibitor of mutant isocitrate dehydrogenase 1 (IDH1). The aim of the study was to determine the safety and clinical activity of olutasidenib in patients with relapsed/refractory gliomas harboring an IDH1R132X mutation. Methods: This was an open-label, multicenter, nonrandomized, phase Ib/II clinical trial. Eligible patients (≥18 years) had histologically confirmed IDH1R132X-mutated glioma that relapsed or progressed on or following standard therapy and had measurable disease. Patients received olutasidenib, 150 mg orally twice daily (BID) in continuous 28-day cycles. The primary endpoin..
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Funding Acknowledgements
This study was funded by Forma Therapeutics, Inc., Watertown, MA, USA.