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DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Sponsor: Day One Biopharmaceuticals, Inc.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
Any - 25 Years
Study Type
INTERVENTIONAL
Enrollment
418
Start Date
2023-02-27
Completion Date
2031-06
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Tovorafenib
Oral Tablet Powder for Oral Suspension
Chemotherapeutic Agent
Intravenous solution for injection
Locations (138)
Children's of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County Main Campus - Orange
Orange, California, United States
Packard Children's Hospital Stanford
Palo Alto, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida Health
Gainesville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
University of Iowa Hospitals Clinics
Iowa City, Iowa, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Maine Children's Cancer Program
Scarborough, Maine, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan - - C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Minnesota
Minneapolis, Minnesota, United States
Childrens MS Cncr Ctr Bld Dsr
Jackson, Mississippi, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Albany Medical Center
Albany, New York, United States
New York University Langone Health
New York, New York, United States
Columbia University
New York, New York, United States
University of Rochester
Rochester, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Oregon Health Science University
Portland, Oregon, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Children's Health Queensland Hospital and Health Service
South Brisbane, Queensland, Australia
Perth Children's Hospital
Nedlands, Australia
Women's and Children's Health Network
North Adelaide, Australia
The Royal Children's Hospital - Children's Cancer Centre
Parkville, Australia
Sydney Children's Hospital - Randwick
Randwick, Australia
Children's Hospital at Westmead
Westmead, Australia
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria
Medizinische Universität Wien
Vienna, Austria
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium
Grupo de Apoio ao Adolescente e à Criança com Câncer (GRAACC)
São Paulo, Brazil
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital London Health Sciences Centre
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
The Montreal Children's Hospital
Montreal, Quebec, Canada
Centre Hospitalier de l'Université Laval et Centre Mère-Enfant Soleil
Québec, Canada
SickKids - The Hospital for Sick Children
Toronto, Canada
Fakultní Nemocnice Brno - D?tská Nemocnice
Brno, Czechia
Motol University Hospital
Prague, Czechia
Aarhus Universitetshospital
Aarhus, Central Jutland, Denmark
Rigshospitalet
Copenhagen, Denmark
CCHE
Cairo, Cairo Governorate, Egypt
Helsingin yliopistollinen sairaala (HUS)
Helsinki, Finland
Tampereen Yliopistollinen Sairaala
Tampere, Finland
Centre de Lutte contre le Cancer - Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
Hôpital de la Timone
Marseille, France
Institut Curie
Paris, France
Gustave Roussy
Villejuif, France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitätsklinikum Augsburg
Augsburg, Bavaria, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
Evangelische Klinikum Bethel (EvKB)
Bielefeld, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Aghia Sofia General Children's Hospital
Athens, Greece
Athens General Children's Hospital
Athens, Greece
Semmelweis Egyetem Tűzoltó utcai II. Sz. Gyermekgyógyászati Kliniká
Budapest, Hungary
Children's Health Ireland at Crumlin
Crumlin, Dublin, Ireland
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
The Edmond and Lily Safra Children's Hospital
Ramat Gan, Israel
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Milan, Italy
Ospedale Pediatrico Bambino Gesù
Roma, Rome, Italy
Ospedale Infantile Regina Margherita
Torino, Turin, Italy
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
Bari, Italy
Azienda Ospedaliera U. Meyer
Florence, Italy
Istituto Giannina Gaslini
Genova, Italy
Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon
Naples, Italy
Azienda Ospedale Università di Padova
Padova, Italy
Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
Udine, Italy