DAY101-001/PNOC026/FIREFLY-1: A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients with BRAF-Altered Recurrent or Progressive Low-Grade Glioma

Brief description of study

The purpose of the study is to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma harboring a known BRAF alteration. DAY101 for oral dosing is provided as a white to off-white crystalline powder as an immediate-release tablet in 2 strengths, 20 mg and 100 mg. The study drug DAY101 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s21-00234
ClinicalTrials.gov Identifier: NCT04775485
Principal Investigator: Sharon L Gardner.
Other Investigators: Devorah Segal, Jessica Clymer.


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