DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy
Day One Biopharmaceuticals, Inc.
400 participants
Feb 27, 2023
INTERVENTIONAL
Conditions
Summary
This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in participants with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring first-line systemic therapy.
Eligibility
Inclusion Criteria4
- Less than 25 years of age with LGG with known activating RAF alteration.
- Histopathologic diagnosis of glioma or glioneuronal tumor.
- At least one measurable lesion as defined by RANO criteria.
- Meet indication for first-line systemic therapy.
Exclusion Criteria7
- Participant has any of the following tumor-histological findings:
- Schwannoma
- Subependymal giant cell astrocytoma (Tuberous Sclerosis)
- Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
- Participant's tumor has additional pathogenic molecular alterations, including but not limited to a) isocitrate dehydrogenase (IDH) 1/2 mutation, b) Histone H3 mutation, and c) neurofibromatosis Type 1 (NF-1) loss of function alteration.
- Known or suspected diagnosis of NF-1/ neurofibromatosis Type 2 (NF-2).
- Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.
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Interventions
Oral Tablet Powder for Oral Suspension
Intravenous solution for injection
Locations(138)
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NCT05566795