Gliomas Clinical Trial
Official title:
Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Low-Grade Gliomas in Adults
To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors
Primary Objective: 1. To evaluate the ability of ulixertinib to penetrate the BBB in patients with recurrent MAPK-activated LGG (ulixertinib tumor concentration, tumor/plasma ratio and tumor/cerebrospinal fluid (CSF) ratio) Secondary Objectives: 1. To assess anti-tumor activity of ulixertinib for patients with recurrent lower grade MAPK-activated gliomas after surgical resection based on: 1. Median progression-free-survival (mPFS) 2. Objective response rate (ORR) at 12 months 3. Disease control rate (DCR) at 12 months 4. Duration of response (DOR) 5. Time to response (TTR) 6. Time to next intervention 2. To assess safety and tolerability of ulixertinib in MAPK-activated LGG ;
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