Safusidenib for Patients With Newly Diagnosed IDH1-mutant CNS WHO Grade 3 Oligodendroglioma and Astrocytoma - a Single Arm Phase II Study
brief summary
The precise positioning of the emerging group of pharmacological inhibitors of mutant IDH enzymes remains to be refined by further studies and defined in national and international guidelines. The present study shall help to close this important knowledge gap when trying to define the role of mutant IDH inhibitors in the treatment algorithms for patients with IDH-mutant WHO grade 3 gliomas. Safusidenib is a novel, oral, potent, brain penetrant inhibitor of mutant IDH1. It has shown high blood brain barrier penetration in both pre-clinical and clinical studies and demonstrated anti-tumor activity with complete or partial responses. We aim at demonstrating the efficacy of safusidenib in patients with newly diagnosed IDH1-mutant CNS WHO grade 3 oligodendroglioma and astrocytoma, measured by progression-free survival at12 months.
detailed description
Patients meeting the eligibility criteria will be asked whether they are willing to participate in the study. After the consent has been signed, patients will be enrolled. They will then start treatment with safusidenib, 250 mg BID until disease progression, unacceptable toxicity, withdrawal of consent or at investigator discretion. A brain MRI will be performed every 2 months during the first 6 months and then every 3 months.