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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05566795




Registration number
NCT05566795
Ethics application status
Date submitted
16/09/2022
Date registered
4/10/2022

Titles & IDs
Public title
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Scientific 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
Secondary ID [1] 0 0
2022-001363-27
Secondary ID [2] 0 0
DAY101-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low-grade Glioma 0 0
Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma 0 0
Pediatric Low-grade Glioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tovorafenib
Treatment: Drugs - Chemotherapeutic Agent

Experimental: Tovorafenib -

Active comparator: Investigator's choice of Standard of care therapy -


Treatment: Drugs: Tovorafenib
Oral Tablet Powder for Oral Suspension

Treatment: Drugs: Chemotherapeutic Agent
Intravenous solution for injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [1] 0 0
Up to 60 months
Secondary outcome [1] 0 0
Progression-free survival (PFS) of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [1] 0 0
Up to 60 months
Secondary outcome [2] 0 0
Event-free survival (EFS) of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [2] 0 0
Up to 60 months
Secondary outcome [3] 0 0
Overall survival (OS) of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [3] 0 0
Up to 60 months
Secondary outcome [4] 0 0
Number of participants with any treatment-emergent adverse events, and Serious adverse events
Timepoint [4] 0 0
Up to 60 months
Secondary outcome [5] 0 0
. Number of participants with clinically significant vital signs and laboratory abnormalities findings
Timepoint [5] 0 0
Up to 60 months
Secondary outcome [6] 0 0
Change from baseline in Adaptive Behavior Composite Score (ABS) of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [6] 0 0
Baseline, Year 1, 2 and 5
Secondary outcome [7] 0 0
Change from baseline in the Motor Skills Domain Score of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [7] 0 0
Baseline, Year 1, 2 and 5
Secondary outcome [8] 0 0
Change from baseline in the Daily Living Domain Score of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [8] 0 0
Baseline, Year 1, 2 and 5
Secondary outcome [9] 0 0
Change from baseline in the Communication Domain Score of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [9] 0 0
Baseline, Year 1, 2 and 5
Secondary outcome [10] 0 0
Change from baseline in the Socialization Domain Score of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [10] 0 0
Baseline, Year 1, 2 and 5
Secondary outcome [11] 0 0
Change in age-adjusted visual acuity (VA) of tovorafenib monotherapy versus SoC chemotherapy in optic pathway glioma (OPG) participants aged < 3 years
Timepoint [11] 0 0
Baseline and up to 5 years
Secondary outcome [12] 0 0
Change in best corrected visual acuity of tovorafenib monotherapy versus SoC chemotherapy in OPG participants aged = 3 years
Timepoint [12] 0 0
Baseline and up to 5 years
Secondary outcome [13] 0 0
Visual progression-free survival (v-PFS) of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [13] 0 0
Up to 60 months
Secondary outcome [14] 0 0
ORR of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [14] 0 0
Up to 60 months
Secondary outcome [15] 0 0
Clinical bene?t rate (CBR) of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [15] 0 0
Up to 60 months
Secondary outcome [16] 0 0
Time to response (TTR) of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [16] 0 0
Up to 60 months
Secondary outcome [17] 0 0
PFS of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [17] 0 0
Up to 60 months
Secondary outcome [18] 0 0
EFS of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [18] 0 0
Up to 60 months
Secondary outcome [19] 0 0
Duration of response (DOR) of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [19] 0 0
Up to 60 months
Secondary outcome [20] 0 0
Change from Baseline in health-related quality of life (HRQoL) total score of tovorafenib monotherapy versus SoC chemotherapy
Timepoint [20] 0 0
Baseline, Year 1, 2 and 5

Eligibility
Key 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.
Minimum age
No limit
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant 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
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2030
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Children's Health Queensland Hospital and Health Service - South Brisbane
Recruitment hospital [2] 0 0
Perth Children's Hospital - Nedlands
Recruitment hospital [3] 0 0
Women's and Children's Health Network - North Adelaide
Recruitment hospital [4] 0 0
The Royal Children's Hospital - Children's Cancer Centre - Parkville
Recruitment hospital [5] 0 0
Sydney Children's Hospital - Randwick - Randwick
Recruitment hospital [6] 0 0
Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
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Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
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State/province [15] 0 0
Missouri
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Nebraska
Country [17] 0 0
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New York
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North Carolina
Country [19] 0 0
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Ohio
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Texas
Country [21] 0 0
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Washington
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United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Austria
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Tirol
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Austria
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Wien
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Belgium
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Brussel
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Ghent
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São Paulo
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Helsinki
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Tampere
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Lille
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France
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Paris
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France
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Villejuif
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Nordrhein-Westfalen
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Germany
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Sachsen
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Berlin
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Bielefeld
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Hamburg
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Heidelberg
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Petah tikva
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Ramat Gan
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Rome
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Muhafazat al-Asima
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Seoul
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Netherlands
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Utrecht
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Grafton
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Troms
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Oslo
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Singapore
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Ljubljana
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Barakaldo
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Barcelona
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Madrid
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Sevilla
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Valencia
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Göteborg
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Lund
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Taipei
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Taoyuan
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England
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Scotland
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United Kingdom
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South Yorkshire
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Surrey
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Bristol
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United Kingdom
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Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Day One Biopharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
SIOPe Brain Tumor Group LOGGIC Consortium
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Day One Clinical Trials Information
Address 0 0
Country 0 0
Phone 0 0
650-484-0899
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05566795