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
Status: Recruiting
Location: See all (130) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 25
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Children's of Alabama
RECRUITING
Birmingham
Arizona
Phoenix Children's Hospital
RECRUITING
Phoenix
California
Children's Hospital Los Angeles
RECRUITING
Los Angeles
Children's Hospital of Orange County Main Campus - Orange
RECRUITING
Orange
UCSF Benioff Children's Hospital
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Florida
University of Florida Health
RECRUITING
Gainesville
Arnold Palmer Hospital for Children
RECRUITING
Orlando
Johns Hopkins All Children's Hospital
RECRUITING
St. Petersburg
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Iowa
University of Iowa Hospitals Clinics
RECRUITING
Iowa City
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
Indiana
Riley Hospital for Children at Indiana University Health
RECRUITING
Indianapolis
Kentucky
Norton Children's Hospital
RECRUITING
Louisville
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Maine
Maine Children's Cancer Program
RECRUITING
Scarborough
Michigan
University of Michigan - - C.S. Mott Children's Hospital
RECRUITING
Ann Arbor
Minnesota
Children's Minnesota
RECRUITING
Minneapolis
Missouri
St. Louis Children's Hospital
RECRUITING
St Louis
North Carolina
Duke Cancer Institute
RECRUITING
Durham
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New York
Albany Medical Center
RECRUITING
Albany
Columbia University
RECRUITING
New York
New York University Langone Health
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Ohio
Cleveland Clinic Main Campus
RECRUITING
Cleveland
Oregon
Oregon Health Science University
RECRUITING
Portland
Texas
Dell Children's Medical Center of Central Texas
RECRUITING
Austin
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Texas Children's Hospital
RECRUITING
Houston
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Wisconsin
University of Wisconsin - Madison
RECRUITING
Madison
Other Locations
Australia
Perth Children's Hospital
RECRUITING
Nedlands
Women's and Children's Health Network
RECRUITING
North Adelaide
The Royal Children's Hospital - Children's Cancer Centre
RECRUITING
Parkville
Sydney Children's Hospital - Randwick
RECRUITING
Randwick
Children's Health Queensland Hospital and Health Service
RECRUITING
South Brisbane
Children's Hospital at Westmead
RECRUITING
Westmead
Austria
Medizinische Universität Innsbruck
RECRUITING
Innsbruck
Medizinische Universität Wien
RECRUITING
Vienna
Belgium
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
Universitair Ziekenhuis Gent
RECRUITING
Ghent
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
RECRUITING
Leuven
Brazil
Grupo de Apoio ao Adolescente e à Criança com Câncer (GRAACC)
RECRUITING
São Paulo
Canada
Alberta Children's Hospital
RECRUITING
Calgary
Stollery Children's Hospital
RECRUITING
Edmonton
McMaster Children's Hospital
RECRUITING
Hamilton
Children's Hospital London Health Sciences Centre
RECRUITING
London
CHU Sainte-Justine
RECRUITING
Montreal
The Montreal Children's Hospital
RECRUITING
Montreal
Children's Hospital of Eastern Ontario
RECRUITING
Ottawa
Centre Hospitalier de l'Université Laval et Centre Mère-Enfant Soleil
RECRUITING
Québec
SickKids - The Hospital for Sick Children
RECRUITING
Toronto
British Columbia Children's Hospital
RECRUITING
Vancouver
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Finland
Helsingin yliopistollinen sairaala (HUS)
RECRUITING
Helsinki
Tampereen Yliopistollinen Sairaala
RECRUITING
Tampere
France
Centre de Lutte contre le Cancer - Centre Oscar Lambret
RECRUITING
Lille
Centre Léon Bérard
RECRUITING
Lyon
Hôpital de la Timone
RECRUITING
Marseille
Institut Curie
RECRUITING
Paris
Gustave Roussy
RECRUITING
Villejuif
Germany
Universitätsklinikum Augsburg
RECRUITING
Augsburg
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Evangelische Klinikum Bethel (EvKB)
RECRUITING
Bielefeld
Universitätsklinikum Erlangen
RECRUITING
Erlangen
Universitaetsklinikum Essen
RECRUITING
Essen
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt Am Main
Universitätsklinikum Freiburg
RECRUITING
Freiburg Im Breisgau
Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Universitätsklinikum Würzburg
RECRUITING
Würzburg
Greece
Aghia Sofia General Children's Hospital
RECRUITING
Athens
Athens General Children's Hospital
RECRUITING
Athens
Hungary
Semmelweis Egyetem Tűzoltó utcai II. Sz. Gyermekgyógyászati Kliniká
RECRUITING
Budapest
Ireland
Children's Health Ireland at Crumlin
RECRUITING
Crumlin
Israel
Schneider Children's Medical Center of Israel
RECRUITING
Petah Tikva
The Edmond and Lily Safra Children's Hospital
RECRUITING
Ramat Gan
Italy
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
RECRUITING
Bari
Istituto Giannina Gaslini
RECRUITING
Genova
Fondazione IRCCS - Istituto Nazionale dei Tumori
RECRUITING
Milan
Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon
RECRUITING
Napoli
Azienda Ospedale Università di Padova
RECRUITING
Padua
Ospedale Pediatrico Bambino Gesù
RECRUITING
Roma
Ospedale Infantile Regina Margherita
RECRUITING
Torino
Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
RECRUITING
Udine
Jordan
King Hussein Cancer Foundation - King Hussein Cancer Center
RECRUITING
Amman
Netherlands
Prinses Maxima Centrum Kinderoncologie
RECRUITING
Utrecht
New Zealand
Starship Paediatric Blood & Cancer Center
RECRUITING
Grafton
Norway
Oslo Universitetssykehus
RECRUITING
Oslo
Universitetssykehuset Nord-Norge - Tromsø
RECRUITING
Tromsø
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Singapore
SingHealth Group - KK Women's and Children's Hospital
RECRUITING
Singapore
Slovenia
Univerzitetni Klinini Center Ljubljana
RECRUITING
Ljubljana
Spain
Hospital Universitario Cruces
RECRUITING
Barakaldo
Hospital Sant Joan de Déu Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebrón
RECRUITING
Barcelona
Hospital Infantil Universitario Niño Jesús
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Universitari i Politècnic La Fe
RECRUITING
Valencia
Sweden
Drottning Silvias barn- och ungdomssjukhus
RECRUITING
Gothenburg
Skånes Universitetssjukhus - Lund
RECRUITING
Lund
Astrid Lindgrens Barnsjukhus Solna
RECRUITING
Stockholm
Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne
RECRUITING
Lausanne
Universitaets - Kinderspital Zürich
RECRUITING
Zurich
Taiwan
Taipei Medical University Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital - Linkou Branch
RECRUITING
Taoyuan District
United Kingdom
Royal Belfast Hospital for Sick Children
RECRUITING
Belfast
Birmingham Women's and Children's NHS Foundation Trust
RECRUITING
Birmingham
University Hospitals Bristol and Weston NHS Foundation Trust
RECRUITING
Bristol
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
NHS Greater Glasgow and Clyde
RECRUITING
Glasgow
Leeds Teaching Hospital NHS Trust
RECRUITING
Leeds
Alder Hey Children's NHS Foundation Trust
RECRUITING
Liverpool
Manchester University NHS Foundation Trust
RECRUITING
Manchester
The Christie Hospital
RECRUITING
Manchester
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle Upon Tyne
Great Ormond Street Hospital for Children
RECRUITING
Oxford
Sheffield Children's Hospital
RECRUITING
Sheffield
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
The Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
Contact Information
Primary
Day One Clinical Trials Information
clinicaltrials@dayonebio.com
650-484-0899
Time Frame
Start Date: 2023-02-27
Estimated Completion Date: 2030-03
Participants
Target number of participants: 400
Treatments
Experimental: Tovorafenib
Active_comparator: Investigator's choice of Standard of care therapy
Related Therapeutic Areas
Sponsors
Leads: Day One Biopharmaceuticals, Inc.
Collaborators: SIOPe Brain Tumor Group LOGGIC Consortium