RECRUITING

A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.

Official 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 RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors

Quick Facts

Study Start:2021-04-22
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04775485

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.

Ages Eligible for Study:6 Months to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Low Grade Glioma \& Low-Grade Glioma Extension: a relapsed or progressive LGG with documented known activating BRAF alteration.
  2. * Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion.
  3. * Participants must have histopathologic verification of malignancy at either original diagnosis or relapse.
  4. * Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.
  5. * Must have at least 1 measurable lesion as defined by RANO (Arms 1 \& 2) or RECIST v1.1 (Arm 3) criteria
  1. * Participant's tumor has additional previously-known activating molecular alterations.
  2. * Participant has symptoms of without radiographically recurrent or radiographically progressive disease.
  3. * Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.

Contacts and Locations

Study Contact

Day One Biopharmaceuticals, Inc.
CONTACT
650-484-0899
firefly-1@dayonebio.com

Study Locations (Sites)

UCSF Benioff Children's Hospital
San Francisco, California, 94143
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21231
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
St. Louis Children's Hospital
Saint Louis, Missouri, 63110
United States
NYU Langone Health
New York, New York, 10016
United States
Duke Cancer Center
Durham, North Carolina, 27710
United States
Doernbecher Children's Hospital Oregon & Health Science University
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84113
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Day One Biopharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-22
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2021-04-22
Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

  • Low-grade Glioma
  • Advanced Solid Tumor
  • FIREFLY-1
  • DAY101
  • Tovorafenib

Additional Relevant MeSH Terms

  • Low-grade Glioma
  • Advanced Solid Tumor