Groupe d'Etude en Oncologie du Quebec

Title	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
Protocole ID	FIREFLY-1
ClinicalTrials.gov ID	NCT04775485
Cancer Type(s)	Pediatric
Phase	Phase II
Stage
Study Type	Clinical
Drug	DAY101
Institution	CHU DE QUEBEC – UNIVERSITE LAVAL CHUL ET CENTRE MERE-ENFANT SOLEIL 2705 boulevard Laurier, Québec, QC, G1V 4G2
City
Principal Investigator	Dr. Valérie Larouche
Coordinator	Panagiota Giannakouros 418-525-4444 poste 40121
Status	Recruiting
Activation Date
Eligibility Criteria	Age 6 months to 25 years with a relapsed or progressive LGG with known activating BRAF alteration Confirmation of histopathologic diagnosis of LGG and molecular diagnosis of activating BRAF alteration Must have received at least one line of systemic therapy and have evidence of radiographic progression Must have at least 1 measurable lesion as defined by RANO criteria
Exclusion Criteria	Patient's tumor has additional previously-known activating molecular alterations Patient has symptoms of clinical progression in the absence of radiographic progression Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) Other inclusion/exclusion criteria as stipulated by protocol may apply

Groupe d'étude en oncologie du Québec