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NCT04775485 · ClinicalTrials.gov record · last posted 2025-04-10

A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

Study acronym: FIREFLY-1
StatusRecruiting
PhasePhase 2
Started2021-04-22
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.

Amendment record 14 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 14 times since 2021-02-25; most recent amendment 2025-03-27. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-03-27
Status change Active, Not RecruitingRecruitingv14
2024-05-09
Status change RecruitingActive, Not Recruitingv13
2021-04-28
Status change Not Yet RecruitingRecruitingv1
Trial Details
NCT Number NCT04775485
Lead Sponsor Day One Biopharmaceuticals, Inc.
Collaborators: Pacific Pediatric Neuro-Oncology Consortium
Conditions Low-grade Glioma, Advanced Solid Tumor
Enrollment 141 participants
Start Date 2021-04-22
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-10