Groupe d'Etude en Oncologie du Quebec

Titre	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
Type(s) de cancer	Pédiatrique divers
Phase	Phase II
Type étude	Clinique
Médicament	DAY101
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL HOPITAL DE MONTREAL POUR ENFANTS 1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville	Montréal
Investigateur(trice) principal(e)	Dre Nada Jabado
Coordonnateur(trice)	Lisa Mooney 514-412-4400
Statut	Actif en recrutement
Critètes d'éligibilité	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
Critètes d'exclusion	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