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RecruitingLast updated: 5 February 2024

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.

Conditions

This trial is treating patients with low-grade glioma.

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People0 - 25

Phase

II

Trial Acronym

FIREFLY-1

More information

Trial Identifiers

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Trial 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

  • Age 6 months to 25 years with:

    1. Arms 1 & 2: a relapsed or progressive LGG with documented known activating BRAF alteration
    2. Arm 3: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion
  • Confirmation of histopathologic diagnosis of LGG and molecular diagnosis of activating BRAF alteration
  • Must have received at least one line of systemic therapy and have evidence of radiographic progression
  • Must have at least 1 measurable lesion as defined by RANO (Arms 1 & 2) or RECIST v1.1 (Arm 3) criteria

Exclusion

  • Patient's tumor has additional previously-known activating molecular alterations
  • Patient has symptoms of clinical progression in the absence of radiographic progression
  • Known or suspected diagnosis of neurofibromatosis type 1 (NF-1)
  • Other inclusion/exclusion criteria as stipulated by protocol may apply

Inclusion

  • 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.

Exclusion

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

Clinical trials have complex eligibility criteria.

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

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