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 RAF-Altered Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Low-grade Glioma
-
Age: Between 6 Month(s) - 25 Year(s)
-
Gender: Male or Female
-
Other Inclusion Criteria:
1) Relapsed or progressive LGG with a documented known activating BRAF alteration, as identified through molecular assays as routinely performed at CLIA or other similarly certified laboratories. 2) Confirmation of histopathologic diagnosis of LGG from either original diagnosis or relapse/progression. 3) Patients must have received at least 1 line of systemic therapy and have documented evidence of radiographic progression.
You may not be eligible for this study if the following are true:
-
1) Patient’s tumor has additional previously-known activating molecular alterations (e.g., histone mutation, IDH1/2 mutations, FGFR mutations or fusions, MYBL alterations, NF1 somatic or germline mutations). 2) Patient has symptoms of clinical progression without radiographically recurrent or radiographically progressive disease. 3) Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.