DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
NCT ID: NCT05566795
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2023-02-27
2030-03-31
Brief Summary
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Detailed Description
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Arm 1 (tovorafenib): Treatment cycles will repeat every 28 days in the absence of disease progression. Participants will continue tovorafenib until any of the following occurs: disease progression, unacceptable toxicity, withdrawal of consent to treatment, or end of study.
Arm 2 (Investigator's Choice of SoC Chemotherapy): Participants will receive one of 4 SoC chemotherapy options selected by the treating Investigator: Children's Oncology Group - Vincristine/Carboplatin (COG-V/C) regimen, International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C) regimen, vinblastine (VBL) regimen, or monthly carboplatin. The choice of SoC chemotherapy regimen will be selected prior to participant randomization. Treatment will continue until completion of therapy or until any of the following occurs: disease progression, unacceptable toxicity, withdrawal of consent to treatment, or end of study.
Participants who discontinue treatment due to disease progression will have (1) radiographic evidence of disease progression, as determined by the Investigator, or (2) clinical progression, as determined by the Investigator. Investigators are encouraged to discuss cases of clinical progression and early radiographic progression without clinical symptoms with the Sponsor Medical Monitor prior to treatment discontinuation or initiation of a different form of treatment for the malignancy. Participants may continue therapy beyond progressive disease (PD).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tovorafenib
Tovorafenib
Oral Tablet Powder for Oral Suspension
Investigator's choice of Standard of care therapy
Chemotherapeutic Agent
Intravenous solution for injection
Interventions
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Tovorafenib
Oral Tablet Powder for Oral Suspension
Chemotherapeutic Agent
Intravenous solution for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histopathologic diagnosis of glioma or glioneuronal tumor.
* At least one measurable lesion as defined by RANO criteria.
* Meet indication for first-line systemic therapy.
Exclusion Criteria
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.
25 Years
ALL
No
Sponsors
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SIOPe Brain Tumor Group LOGGIC Consortium
UNKNOWN
Day One Biopharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Napoli, , Italy
Azienda Ospedale Università di Padova
Padua, , Italy
Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
Udine, , Italy
King Hussein Cancer Foundation - King Hussein Cancer Center
Amman, Muhafazat al-Asima, Jordan
Prinses Maxima Centrum Kinderoncologie
Utrecht, , Netherlands
Starship Paediatric Blood & Cancer Center
Grafton, , New Zealand
Universitetssykehuset Nord-Norge - Tromsø
Tromsø, Troms, Norway
Oslo Universitetssykehus
Oslo, , Norway
Sidra Medicine
Doha, , Qatar
SingHealth Group - KK Women's and Children's Hospital
Singapore, , Singapore
Univerzitetni Klinini Center Ljubljana
Ljubljana, , Slovenia
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Hospital Universitario Cruces
Barakaldo, , Spain
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Hospital Sant Joan de Déu Barcelona
Barcelona, , Spain
Hospital Infantil Universitario Niño Jesús
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Drottning Silvias barn- och ungdomssjukhus
Gothenburg, , Sweden
Skånes Universitetssjukhus - Lund
Lund, , Sweden
Astrid Lindgrens Barnsjukhus Solna
Stockholm, , Sweden
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, , Switzerland
Universitaets - Kinderspital Zürich
Zurich, , Switzerland
Taipei Medical University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan District, , Taiwan
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, England, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, England, United Kingdom
Manchester University NHS Foundation Trust
Manchester, England, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, England, United Kingdom
Great Ormond Street Hospital for Children
Oxford, England, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, United Kingdom
Sheffield Children's Hospital
Sheffield, South Yorkshire, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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References
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van Tilburg CM, Kilburn LB, Perreault S, Schmidt R, Azizi AA, Cruz-Martinez O, Zapotocky M, Scheinemann K, Meeteren AYNS, Sehested A, Opocher E, Driever PH, Avula S, Ziegler DS, Capper D, Koch A, Sahm F, Qiu J, Tsao LP, Blackman SC, Manley P, Milde T, Witt R, Jones DTW, Hargrave D, Witt O. LOGGIC/FIREFLY-2: a phase 3, randomized trial of tovorafenib vs. chemotherapy in pediatric and young adult patients with newly diagnosed low-grade glioma harboring an activating RAF alteration. BMC Cancer. 2024 Jan 30;24(1):147. doi: 10.1186/s12885-024-11820-x.
Other Identifiers
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2022-001363-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DAY101-002
Identifier Type: -
Identifier Source: org_study_id