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RecruitingLast updated: 23 May 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 alterationA 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

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Day One Biopharmaceuticals, Inc.

Scientific Title

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

Exclusion

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

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

This trial is operating as a teletrial at one or more locations. Learn more about teletrials.

Recruiting hospitals

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