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

RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors in pediatric patients

Arm 1 (Low-Grade Glioma): ORR by RANO-HGG criteria; Arm 2 (Low-Grade Glioma Extension): Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities; Arm 3 (Advanced Solid Tumor): Measured by the proportion of patients with best overall confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 or RANO-HGG criteria

Arm 1 (Low-Grade Glioma): Type, frequency, and severity of AEs and laboratory abnormalities; -Pharmacokinetic profile of DAY101 (e.g., area under the concentration-time curve [AUC], Cmin, etc.); Time following initiation of DAY101 to progression or death in patients treated with DAY101 - length of response in patients with best overall confirmed response of CR or PR; Time to first response following initiation of DAY101 in patients with best overall confirmed response of CR or PR, Arm 2 (Low-Grade Glioma Extension): -Measured by the proportion of patients with best overall confirmed response of CR or PR as determined by the RANO criteria; Measured by the proportion of patients with best overall confirmed response of CR or PR by RAPNO–low-grade glioma criteria, Arm 3 (Advanced Solid Tumor): Type, frequency, and severity of AEs and laboratory abnormalities; Pharmacokinetic profile of DAY101 (e.g., AUC, Cmin, etc.)

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Denmark, Germany, Netherlands