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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
Date last updated
4/06/2025
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)
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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
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Secondary ID [1]
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2022-001363-27
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Secondary ID [2]
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DAY101-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Low-grade Glioma
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0
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Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma
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Pediatric Low-grade Glioma
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Condition category
Condition code
Cancer
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0
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Brain
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Cancer
0
0
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0
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
0
0
0
0
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Bone
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective response rate (ORR) of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [1]
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ORR assessed per Response Assessment in Pediatric Neuro Oncology (RAPNO) criteria by Independent Review Committee (IRC), and defined as the proportion of participants with overall confirmed response of complete response (CR), partial response (PR), or minor response (MR).
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Timepoint [1]
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Up to 60 months
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Secondary outcome [1]
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Progression-free survival (PFS) of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [1]
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PFS assessed per RAPNO criteria by IRC, and de?ned as time from randomization to PD or death from any cause, whichever comes first.
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Timepoint [1]
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Up to 60 months
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Secondary outcome [2]
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Event-free survival (EFS) of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [2]
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EFS assessed per RAPNO criteria by IRC, de?ned as time from randomization to PD, death from any cause, or initiation of any new anticancer therapy, whichever comes first.
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Timepoint [2]
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0
Up to 60 months
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Secondary outcome [3]
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Overall survival (OS) of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [3]
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Overall survival is defined as time from randomization up to death from any cause.
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Timepoint [3]
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Up to 60 months
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Secondary outcome [4]
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Number of participants with any treatment-emergent adverse events, and Serious adverse events
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Assessment method [4]
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Type, frequency, and severity of adverse events of tovorafenib monotherapy versus SoC chemotherapy will be assessed.
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Timepoint [4]
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0
Up to 60 months
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Secondary outcome [5]
0
0
. Number of participants with clinically significant vital signs and laboratory abnormalities findings
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Assessment method [5]
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Type, frequency, and severity of vital signs and laboratory abnormalities of tovorafenib monotherapy versus SoC chemotherapy will be assessed.
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Timepoint [5]
0
0
Up to 60 months
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Secondary outcome [6]
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0
Change from baseline in Adaptive Behavior Composite Score (ABS) of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [6]
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Adaptive behavior Composite Score will be evaluated using domain scores collected from the comprehensive Vineland III Adaptive Behavior Scale (VABS).
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Timepoint [6]
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Baseline, Year 1, 2 and 5
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Secondary outcome [7]
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Change from baseline in the Motor Skills Domain Score of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [7]
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The motor skills (gross and fine) will be assessed using the Motor Skills Score domain of the VABS in pediatric participants.
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Timepoint [7]
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Baseline, Year 1, 2 and 5
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Secondary outcome [8]
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Change from baseline in the Daily Living Domain Score of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [8]
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The daily living (personal, domestic and community) will be assessed using Daily Living Domain Score of VABS.
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Timepoint [8]
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Baseline, Year 1, 2 and 5
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Secondary outcome [9]
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Change from baseline in the Communication Domain Score of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [9]
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The communication skills (receptive, expressive and written) will be assessed using Communication Domain Score of VABS.
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Timepoint [9]
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Baseline, Year 1, 2 and 5
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Secondary outcome [10]
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Change from baseline in the Socialization Domain Score of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [10]
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The socialization skills (Interpersonal relationships, play and leisure time and coping skills) will be assessed using Socialization Domain Score of VABS.
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Timepoint [10]
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Baseline, Year 1, 2 and 5
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Secondary outcome [11]
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Change in age-adjusted visual acuity (VA) of tovorafenib monotherapy versus SoC chemotherapy in optic pathway glioma (OPG) participants aged < 3 years
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Assessment method [11]
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Visual acuity testing using current age-appropriate testing methodology will be performed for all participants at Screening. For participants with OPG or an underlying visual deficit related to the primary malignancy, visual acuity testing will be performed every time participants have a radiographic response assessment. Assessments will be performed in each eye separately at a recommended testing distance of 3 meters.
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Timepoint [11]
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Baseline and up to 5 years
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Secondary outcome [12]
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Change in best corrected visual acuity of tovorafenib monotherapy versus SoC chemotherapy in OPG participants aged = 3 years
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Assessment method [12]
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Visual acuity assessments to be performed by an ophthalmologist or another qualified site clinical personnel.
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Timepoint [12]
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Baseline and up to 5 years
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Secondary outcome [13]
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Visual progression-free survival (v-PFS) of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [13]
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Visual progression-free survival is defined as the time from start of treatment to visual event for OPG participants aged = 3 years.
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Timepoint [13]
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Up to 60 months
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Secondary outcome [14]
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ORR of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [14]
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ORR, defined as the proportion of participants with overall confirmed response per Response Assessment in Neuro-Oncology for High-Grade Glioma (RANO-HGG) criteria (CR or PR) and RANO-LGG criteria (CR, PR, or MR), as applicable.
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Timepoint [14]
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Up to 60 months
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Secondary outcome [15]
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Clinical bene?t rate (CBR) of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [15]
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CBR, de?ned as the proportion of participants with radiological tumor stabilization or regression per RANO-LGG (CR, PR, MR, or SD lasting 12 months or more), RANO-HGG (CR, PR, or SD lasting 12 months or more) or RAPNO criteria (CR, PR, MR or SD lasting 12 months or more), as applicable.
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Timepoint [15]
0
0
Up to 60 months
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Secondary outcome [16]
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Time to response (TTR) of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [16]
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TTR, measured by the time following randomization to ?rst imaging of tumor response that was subsequently con?rmed per RANO-HGG criteria (CR or PR), RANO-LGG criteria (CR, or PR, or MR), or RAPNO criteria (CR, PR, or MR), as applicable.
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Timepoint [16]
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Up to 60 months
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Secondary outcome [17]
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PFS of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [17]
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PFS per RANO-HGG or RANO-LGG criteria (as applicable), de?ned as time from randomization to PD or death from any cause, whichever occurs first.
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Timepoint [17]
0
0
Up to 60 months
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Secondary outcome [18]
0
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EFS of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [18]
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EFS per RANO-HGG or RANO-LGG criteria (as applicable), defined as time from randomization to PD, death from any cause, or initiation of any new anticancer therapy, whichever comes first.
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Timepoint [18]
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0
Up to 60 months
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Secondary outcome [19]
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Duration of response (DOR) of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [19]
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DOR, de?ned as time from first imaging of tumor response per RANO-LGG, RANO-HGG or RAPNO criteria, as applicable, that was subsequently confirmed to radiographic PD or death from any cause, whichever comes first.
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Timepoint [19]
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0
Up to 60 months
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Secondary outcome [20]
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Change from Baseline in health-related quality of life (HRQoL) total score of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [20]
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The Patient-Reported Outcomes Measurement Information System (PROMIS®) Pediatric/Parent Proxy Profile 49 v2.0 will be used to assess mental and social HRQoL.
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Timepoint [20]
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Baseline, Year 1, 2 and 5
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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.
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Minimum age
No limit
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2030
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Children's Health Queensland Hospital and Health Service - South Brisbane
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Recruitment hospital [2]
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Perth Children's Hospital - Nedlands
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Recruitment hospital [3]
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Women's and Children's Health Network - North Adelaide
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Recruitment hospital [4]
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The Royal Children's Hospital - Children's Cancer Centre - Parkville
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Recruitment hospital [5]
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Sydney Children's Hospital - Randwick - Randwick
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Recruitment hospital [6]
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Children's Hospital at Westmead - Westmead
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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5006 - North Adelaide
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Recruitment postcode(s) [4]
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3052 - Parkville
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Recruitment postcode(s) [5]
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2031 - Randwick
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Recruitment postcode(s) [6]
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2145 - Westmead
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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United States of America
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Maine
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Massachusetts
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Tampere
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Lille
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Hessen
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Germany
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Tübingen
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Petah tikva
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Israel
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Ramat Gan
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Italy
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Italy
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Italy
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Genova
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Italy
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Italy
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Padova
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Italy
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Udine
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Jordan
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Muhafazat al-Asima
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Korea, Republic of
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Seoul
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Grafton
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Norway
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Troms
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Norway
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Oslo
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Singapore
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Ljubljana
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Barakaldo
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Spain
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Göteborg
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Sweden
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State/province [84]
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Lund
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Country [85]
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Sweden
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Stockholm
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Country [86]
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Switzerland
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State/province [86]
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Lausanne
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Country [87]
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Switzerland
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State/province [87]
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Zurich
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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State/province [90]
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England
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Country [91]
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United Kingdom
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State/province [91]
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Northern Ireland
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Country [92]
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United Kingdom
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State/province [92]
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Scotland
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Country [93]
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United Kingdom
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State/province [93]
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South Yorkshire
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Country [94]
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United Kingdom
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State/province [94]
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Surrey
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Country [95]
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United Kingdom
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State/province [95]
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Bristol
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United Kingdom
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State/province [96]
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Cambridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Day One Biopharmaceuticals, Inc.
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Address
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Other collaborator category [1]
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Other
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Name [1]
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SIOPe Brain Tumor Group LOGGIC Consortium
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05566795
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Day One Clinical Trials Information
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Phone
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650-484-0899
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Email
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[email protected]
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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
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