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RecruitingLast updated:15 August 2023

FIREFLY-1: This phase II trial is evaluating how safe and effective targeted therapy (DAY101) is in children, adolescents and young adults with recurrent or progressive, low-grade glioma with a known BRAF alterationFIREFLY-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 BRAF-Altered, Recurrent or Progressive Low-Grade Glioma

Clinical summary

Summary

This is a non-randomised study with one experimental arm. Participants will receive DAY101, orally, at a dose of 420mg/m2 once weekly for each 28-day treatment cycle for a planned period of 26 cycles.

Age

People0 - 25

Phase

II

Trial Acronym

FIREFLY-1

More information

Trial Identifiers

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Commercial Sponsor

Day One Biopharmaceuticals, Inc.

Scientific Title

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 BRAF-Altered, Recurrent or Progressive Low-Grade Glioma

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.

Exclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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