DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients 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
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Clinical Trial Information
Trial Contact: Parker, Melanie; Dubberly, Paige D; Doyle, Katherine M; Armatti, Julie M; Spinelli, Jennifer
Trial Phone: 321-843-1036 ; 321-841-7561 ; 3218412008 ; 321-843-5284 ; 321.841.5357
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IRB No: S22.264.12
Protocol Abbrev: DAY101-002
Principal Investigator: Amy A. Smith, MD
Phase: Drug: Phase III
Age Group: Pediatric
Secondary Protocol No: DAY101-002
Treatment: Drug: DAY101; Drug: Chemotherapeutic Agent
Therapies Involved: Monotherapy
ClinicalTrials.gov ID: NCT05566795
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Objective
evaluate the efficacy, safety, and tolerability of DAY101 monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.
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Key Eligibility
- 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
