Trial Title:
DAY101 Vs. Standard of Care Chemotherapy in Pediatric Patients with Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
NCT ID:
NCT05566795
Condition:
Low-grade Glioma
Conditions: Official terms:
Glioma
Antineoplastic Agents
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Tovorafenib versus standard of care chemotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tovorafenib
Description:
Oral type II RAF kinase inhibitor
Arm group label:
Arm #1
Other name:
DAY101, Ojemda
Intervention type:
Drug
Intervention name:
Chemotherapeutic Agent
Description:
Intravenous solution for injection
Arm group label:
Arm #2
Other name:
COG-V/C
Other name:
SIOPe-LGG-V/C
Other name:
VBL
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 patients with pediatric low-grade glioma (LGG) harboring an
activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line
systemic therapy.
Detailed description:
Approximately 400 treatment-naïve low-grade glioma patients will be randomized 1:1 to
either tovorafenib (Arm 1) or an Investigator's choice of SoC chemotherapy (Arm 2).
Arm 1 (tovorafenib): treatment cycles will repeat every 28 days in the absence of disease
progression. Patients will continue tovorafenib until any of the following occurs:
disease progression based on Response Assessment in Neuro-Oncology (RANO-LGG) criteria,
unacceptable toxicity, withdrawal of consent to treatment, or end of study.
Arm 2 (Investigator's Choice of SoC Chemotherapy): patients will receive one of 3 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, or vinblastine (VBL)
regimen. The choice of SoC chemotherapy regimen will be selected prior to patient
randomization. Treatment will continue until completion of therapy or until any of the
following occurs: disease progression based on RANO-LGG criteria, unacceptable toxicity,
withdrawal of consent to treatment, or end of study.
Patients who discontinue treatment due to disease progression will have (1) radiographic
evidence of progressive disease based on RANO-LGG, as determined by the Investigator and
confirmed by the IRC, or (2) clinical progression based on RANO-LGG criteria determined
by the Investigator. Investigators are encouraged to discuss cases of clinical
progression and early radiographic progression without clinical symptom with the Sponsor
Medical Monitor prior to treatment discontinuation or initiation of a different form of
treatment for the malignancy. Patients may continue therapy beyond progressive disease
Criteria for eligibility:
Criteria:
Inclusion 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
Exclusion Criteria:
- Patient 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
- Patient's tumor has additional pathogenic molecular alterations, including but not
limited to a) IDH 1/2 mutation, b) Histone H3 mutation, and c) NF-1 loss of function
alteration.
- Known or suspected diagnosis of neurofibromatosis Type 1 or 2 (NF-1/NF-2)
- Prior or ongoing nonsurgical anticancer therapy for this indication (eg,
chemotherapy, oral/intravenous targeted therapy) including radiation
Gender:
All
Minimum age:
N/A
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's of Alabama
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Facility:
Name:
Phoenix Children's Hospital
Address:
City:
Phoenix
Zip:
85016
Country:
United States
Status:
Recruiting
Facility:
Name:
Children's Hospital Los Angeles
Address:
City:
Los Angeles
Zip:
90027
Country:
United States
Status:
Recruiting
Facility:
Name:
UCSF Benioff Children's Hospital
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Facility:
Name:
Children's Hospital Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Facility:
Name:
Children's National Medical Center
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Recruiting
Facility:
Name:
Arnold Palmer Hospital for Children
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Facility:
Name:
Children's Healthcare of Atlanta
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Facility:
Name:
Ann & Robert H. Lurie Children's Hospital of Chicago
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Facility:
Name:
Riley Hospital for Children at Indiana University Health
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Michigan - - C.S. Mott Children's Hospital
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Louis Children's Hospital
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
New York University Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke Cancer Institute
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Main Campus
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Children's Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Seattle Children's Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Facility:
Name:
Children's Health Queensland Hospital and Health Service
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Facility:
Name:
Perth Children's Hospital
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Women's and Children's Health Network
Address:
City:
North Adelaide
Zip:
5006
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Royal Children's Hospital - Children's Cancer Centre
Address:
City:
Parkville
Zip:
3052
Country:
Australia
Status:
Recruiting
Facility:
Name:
Sydney Children's Hospital - Randwick
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Recruiting
Facility:
Name:
Children's Hospital at Westmead
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Facility:
Name:
Medizinische Universität Innsbruck
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Medizinische Universität Wien
Address:
City:
Wien
Zip:
1090
Country:
Austria
Status:
Recruiting
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Brussel
Zip:
1200
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis Gent
Address:
City:
Ghent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Alberta Children's Hospital
Address:
City:
Calgary
Zip:
T3B 6A8
Country:
Canada
Status:
Recruiting
Facility:
Name:
British Columbia Children's Hospital
Address:
City:
Vancouver
Zip:
V6H 3N1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Children's Hospital of Eastern Ontario
Address:
City:
Ottawa
Zip:
K1H 8L1
Country:
Canada
Status:
Recruiting
Facility:
Name:
CHU Sainte-Justine
Address:
City:
Montréal
Zip:
H3T IC5
Country:
Canada
Status:
Recruiting
Facility:
Name:
The Montreal Children's Hospital
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Centre Hospitalier de l'Université Laval et Centre Mère-Enfant Soleil
Address:
City:
Québec
Zip:
G1V 4G2
Country:
Canada
Status:
Recruiting
Facility:
Name:
SickKids - The Hospital for Sick Children
Address:
City:
Toronto
Zip:
M5G 1X8
Country:
Canada
Status:
Recruiting
Facility:
Name:
Fakultní Nemocnice Brno - D?tská Nemocnice
Address:
City:
Brno
Zip:
625 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Motol University Hospital
Address:
City:
Prague
Zip:
5 150 06
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Aarhus Universitetshospital
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Helsingin yliopistollinen sairaala (HUS)
Address:
City:
Helsinki
Zip:
FI-00290
Country:
Finland
Status:
Recruiting
Facility:
Name:
Tampereen Yliopistollinen Sairaala
Address:
City:
Tampere
Zip:
33520
Country:
Finland
Status:
Recruiting
Facility:
Name:
Centre de Lutte contre le Cancer - Centre Oscar Lambret
Address:
City:
Lille
Zip:
59020
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Facility:
Name:
Hôpital de la Timone
Address:
City:
Marseille
Zip:
13005
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75248
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Freiburg
Address:
City:
Freiburg
Zip:
79106
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Augsburg
Address:
City:
Augsburg
Zip:
86156
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Erlangen
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Würzburg
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Frankfurt
Address:
City:
Frankfurt
Zip:
60590
Country:
Germany
Status:
Recruiting
Facility:
Name:
Medizinische Hochschule Hannover
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Leipzig
Address:
City:
Leipzig
Zip:
4103
Country:
Germany
Status:
Recruiting
Facility:
Name:
Charité Universitätsmedizin Berlin
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Status:
Recruiting
Facility:
Name:
Evangelische Klinikum Bethel (EvKB)
Address:
City:
Bielefeld
Zip:
33617
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Hamburg-Eppendorf
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Tübingen
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Facility:
Name:
Aghia Sofia General Children's Hospital
Address:
City:
Athens
Zip:
11527
Country:
Greece
Status:
Recruiting
Facility:
Name:
Athens General Children's Hospital
Address:
City:
Athens
Zip:
11527
Country:
Greece
Status:
Recruiting
Facility:
Name:
Semmelweis Egyetem Tűzoltó utcai II. Sz. Gyermekgyógyászati Kliniká
Address:
City:
Budapest
Zip:
1094
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Children's Health Ireland at Crumlin
Address:
City:
Crumlin
Zip:
D12 N512
Country:
Ireland
Status:
Recruiting
Facility:
Name:
Schneider Children's Medical Center of Israel
Address:
City:
Petah tikva
Zip:
49202
Country:
Israel
Status:
Recruiting
Facility:
Name:
The Edmond and Lily Safra Children's Hospital
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Fondazione IRCCS - Istituto Nazionale dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Pediatrico Bambino Gesù
Address:
City:
Roma
Zip:
00165
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Infantile Regina Margherita
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Giannina Gaslini
Address:
City:
Genova
Zip:
16147
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedale Università di Padova
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Prinses Maxima Centrum Kinderoncologie
Address:
City:
Utrecht
Zip:
3584 CS
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Starship Paediatric Blood & Cancer Center
Address:
City:
Grafton
Zip:
1023
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
Universitetssykehuset Nord-Norge - Tromsø
Address:
City:
Tromsø
Zip:
9038
Country:
Norway
Status:
Recruiting
Facility:
Name:
Oslo Universitetssykehus
Address:
City:
Oslo
Zip:
372
Country:
Norway
Status:
Recruiting
Facility:
Name:
SingHealth Group - KK Women's and Children's Hospital
Address:
City:
Singapore
Zip:
229899
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Univerzitetni Klinini Center Ljubljana
Address:
City:
Ljubljana
Zip:
1000
Country:
Slovenia
Status:
Recruiting
Facility:
Name:
Hospital Universitario Cruces
Address:
City:
Barakaldo
Zip:
48903
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebrón
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Sant Joan de Déu Barcelona
Address:
City:
Barcelona
Zip:
08950
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Infantil Universitario Niño Jesús
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocío
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari i Politècnic La Fe
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Drottning Silvias barn- och ungdomssjukhus
Address:
City:
Göteborg
Zip:
416 85
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Skånes Universitetssjukhus - Lund
Address:
City:
Lund
Zip:
221 85
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Astrid Lindgrens Barnsjukhus Solna
Address:
City:
Stockholm
Zip:
171 77
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire Vaudois Lausanne
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Universitaets - Kinderspital Zürich
Address:
City:
Zurich
Zip:
8032
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Birmingham Women's and Children's NHS Foundation Trust
Address:
City:
Birmingham
Zip:
B4 6NH
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Leeds Teaching Hospital NHS Trust
Address:
City:
Leeds
Zip:
LS1 3EX
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Alder Hey Children's NHS Foundation Trust
Address:
City:
Liverpool
Zip:
L12 2AP
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Manchester University NHS Foundation Trust
Address:
City:
Manchester
Zip:
M13 PWL
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Address:
City:
Newcastle Upon Tyne
Zip:
NE1 4LP
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Great Ormond Street Hospital for Children
Address:
City:
Oxford
Zip:
WC1N 3JH
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Belfast Hospital for Sick Children
Address:
City:
Belfast
Zip:
BT9 7AB
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
NHS Greater Glasgow and Clyde
Address:
City:
Glasgow
Zip:
G51 4TF
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
University Hospitals Bristol and Weston NHS Foundation Trust
Address:
City:
Bristol
Zip:
BS2 8HW
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Cambridge University Hospitals NHS Foundation Trust
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Start date:
February 27, 2023
Completion date:
March 2030
Lead sponsor:
Agency:
Day One Biopharmaceuticals, Inc.
Agency class:
Industry
Collaborator:
Agency:
SIOPe Brain Tumor Group LOGGIC Consortium
Agency class:
Other
Source:
Day One Biopharmaceuticals, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566795
