DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

Description

This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in participants with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring first-line systemic therapy.

Conditions

Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma, Pediatric Low-grade Glioma

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Study Overview

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Study Details

Study overview

This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in participants with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring first-line systemic therapy.

LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

Condition
Low-grade Glioma
Intervention / Treatment

-

Contacts and Locations

Birmingham

Children's of Alabama, Birmingham, Alabama, United States, 35233

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Orange

Children's Hospital of Orange County Main Campus - Orange, Orange, California, United States, 92868

San Francisco

UCSF Benioff Children's Hospital, San Francisco, California, United States, 94158

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Hartford

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106-3322

Washington

Children's National Medical Center, Washington, District of Columbia, United States, 20010

Gainesville

University of Florida Health, Gainesville, Florida, United States, 32610

Orlando

Arnold Palmer Hospital for Children, Orlando, Florida, United States, 32806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Less than 25 years of age with LGG with known activating RAF alteration.
  • * Histopathologic diagnosis of glioma or glioneuronal tumor.
  • * At least one measurable lesion as defined by RANO criteria.
  • * Meet indication for first-line systemic therapy.
  • * Participant has any of the following tumor-histological findings:
  • 1. Schwannoma
  • 2. Subependymal giant cell astrocytoma (Tuberous Sclerosis)
  • 3. Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
  • * Participant's tumor has additional pathogenic molecular alterations, including but not limited to a) isocitrate dehydrogenase (IDH) 1/2 mutation, b) Histone H3 mutation, and c) neurofibromatosis Type 1 (NF-1) loss of function alteration.
  • * Known or suspected diagnosis of NF-1/ neurofibromatosis Type 2 (NF-2).
  • * Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.

Ages Eligible for Study

to 25 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Day One Biopharmaceuticals, Inc.,

Study Record Dates

2030-03