A Study to Evaluate DAY101 in Pediatric and Young Adult Patients With Relapsed or Progressive Low-Grade Glioma

  • STATUS
    Recruiting
  • End date
    Feb 28, 2024
  • participants needed
    60
  • sponsor
    Day One Biopharmaceuticals, Inc.
Updated on 19 August 2021

Summary

FIREFLY-1 is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma harboring a known BRAF alteration.

Description

Approximately 60 pediatric patients will be treated with DAY101, an oral pan-RAF inhibitor, for a planned period of 26 cycles will be treated with DAY101 for a planned period of 26 cycles (approximately 24 months).

DAY101 will be administered at the recommended Phase 2 dose (RP2D) of 420 mg/m2 (not to exceed 600 mg) orally once weekly (QW) for each 28-day treatment cycle.

Treatment cycles will repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients will undergo radiographic evaluation of their disease at the end of every third cycle. Patients will continue on DAY101 until radiographic evidence of disease progression by RANO criteria as determined by treating investigator, unacceptable toxicity, patient withdrawal of consent, or death.

Patients who have radiographic evidence of disease progression may be allowed to continue DAY101 if, in the opinion of the investigator and approval by the Sponsor, the patient is deriving clinical benefit from continuing study treatment. Disease assessments for patients being treated beyond progression should continue as per regular schedule.

DAY101 is an oral pan-RAF inhibitor administered as an oral tablet at 420 mg/m2 (not to exceed 600 mg).

Details
Condition Low Grade Glioma
Treatment DAY101
Clinical Study IdentifierNCT04775485
SponsorDay One Biopharmaceuticals, Inc.
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 6 months to 25 years with a relapsed or progressive LGG with known activating BRAF alteration
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 criteria

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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