Pédiatrique divers

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TITRE (EN) 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
CLINICAL TRIAL.gov ID NCT04775485
TYPE(S) DE CANCER Pédiatrique divers
PHASE Phase II
TYPE D'ÉTUDE Clinique
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Nada Jabado
COORDONATEUR(RICE) Lisa Mooney
lisa.mooney@muhc.mcgill.ca
514-412-4400
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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
CRITÈRES D'EXCLUSION (EN)
  • 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