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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
6/08/2024
Titles & IDs
Public title
DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients 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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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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Condition category
Condition code
Cancer
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Brain
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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: Arm #1 - Tovorafenib
Active comparator: Arm #2 - Investigator's choice of one of the following current standard of care for pediatric patients with low-grade gliomas:
1. Children's Oncology Group - Vincristine/Carboplatin (COG-V/C)
2. International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C)
3. Vinblastine (VBL)
Treatment: Drugs: Tovorafenib
Oral type II RAF kinase inhibitor
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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Compare the objective response rate (ORR) assessed per RANO-LGG criteria by Independent Review Committee (IRC) of tovorafenib monotherapy versus standard of care (SoC) chemotherapy
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Assessment method [1]
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ORR, per RANO-LGG criteria, defined as the proportion of patients with overall confirmed response of complete response (CR) or partial response (PR)
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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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Compare the progression-free survival (PFS) assessed by IRC of tovorafenib monotherapy versus SoC chemotherapy per RANO-LGG criteria
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Assessment method [1]
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PFS per RANO-LGG criteria, de?ned as time from randomization to PD or death from any cause
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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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Compare the duration of response (DOR) assessed by IRC of tovorafenib monotherapy versus SoC chemotherapy per RANO-LGG criteria
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Assessment method [2]
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DOR per RANO-LGG criteria, de?ned as time from confirmed response to PD or death from any cause for patients with confirmed response
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Timepoint [2]
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Up to 60 months
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Secondary outcome [3]
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Compare the overall survival (OS) of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [3]
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OS, 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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Compare the safety and tolerability of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [4]
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Type, frequency, and severity of treatment-emergent adverse events
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Timepoint [4]
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Up to 60 months
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Secondary outcome [5]
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Compare the safety and tolerability of tovorafenib monotherapy versus SoC chemotherapy
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Assessment method [5]
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Measured by incidence of clinically significant laboratory abnormalities
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Timepoint [5]
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Up to 60 months
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Secondary outcome [6]
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Evaluate changes in neurological function and adaptive behavior between tovorafenib versus SoC
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Assessment method [6]
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Change from baseline in the Vineland Adaptive Behavior Composite Scales \[age-adjusted standard scores range between 20 to 140, with a mean of 100 and standard deviation of 15, and lower scores indicate worse functional outcomes\]
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Timepoint [6]
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Up to 60 months
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Secondary outcome [7]
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Compare changes in visual function outcomes of tovorafenib monotherapy versus SoC chemotherapy in patients with optic pathway glioma (OPG)
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Assessment method [7]
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Measured by Teller Acuity Cards® or alternative
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Timepoint [7]
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Up to 60 months
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Secondary outcome [8]
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Compare the ORR of tovorafenib monotherapy versus SoC chemotherapy as assessed by IRC per RANO-HGG and Response Assessment in Pediatric Neuro-Oncology (RAPNO-LGG) criteria
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Assessment method [8]
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ORR, de?ned as the proportion of patients with overall con?rmed response per RANO-HGG, RANO-LGG, or RAPNO-LGG criteria.
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Timepoint [8]
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Up to 60 months
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Secondary outcome [9]
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Compare the clinical bene?t rate (CBR) of tovorafenib monotherapy versus SoC chemotherapy as assessed by IRC per RANO-LGG, RANO-HGG and RAPNO-LGG criteria
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Assessment method [9]
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CBR, de?ned as the proportion of patients with radiological tumor stabilization or regression per RANO-LGG, RANO-HGG or RAPNO-LGG criteria, as applicable
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Timepoint [9]
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Up to 60 months
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Secondary outcome [10]
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Compare time to response (TTR) of tovorafenib monotherapy versus SoC chemotherapy as assessed by IRC per RANO-LGG, RANO-HGG and RAPNO-LGG criteria
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Assessment method [10]
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Measured by the time to ?rst response following initiation of therapy in patients with best overall con?rmed response per RANO-LGG, RANO-HGG or RAPNO-LGG criteria, as applicable
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Timepoint [10]
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Up to 60 months
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Secondary outcome [11]
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Compare the PFS of tovorafenib monotherapy versus SoC chemotherapy as assessed by IRC per RAPNO-LGG and RANO-HGG criteria
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Assessment method [11]
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PFS per RANO-HGG or RAPNO-LGG (as applicable), de?ned as time from randomization to progressive disease (PD) or death from any cause
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Timepoint [11]
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Up to 60 months
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Secondary outcome [12]
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Compare the DOR of tovorafenib monotherapy versus SoC chemotherapy as assessed by IRC per RAPNO-LGG and RANO-HGG criteria
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Assessment method [12]
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DOR, de?ned as time from con?rmed response to PD or death from any cause for patients with confirmed response per RANO or RAPNO criteria, as applicable
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Timepoint [12]
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Up to 60 months
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Secondary outcome [13]
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Evaluate the health-related quality of life (HRQoL) in tovorafenib versus SoC chemotherapy using Patient-Reported Outcomes Measurement Information System (PROMIS) test battery
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Assessment method [13]
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Measured by change from baseline in Total Score at 1, 2, 5 years
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Timepoint [13]
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Up to 60 months
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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
* 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
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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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Masking / blinding
Open (masking not used)
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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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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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Perth Children's Hospital - Nedlands
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Women's and Children's Health Network - North Adelaide
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The Royal Children's Hospital - Children's Cancer Centre - Parkville
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Sydney Children's Hospital - Randwick - Randwick
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Children's Hospital at Westmead - Westmead
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4101 - South Brisbane
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6009 - Nedlands
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5006 - North Adelaide
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3052 - Parkville
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Recruitment postcode(s) [5]
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2031 - Randwick
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2145 - Westmead
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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
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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 patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.
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Trial website
https://clinicaltrials.gov/study/NCT05566795
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Trial related presentations / publications
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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 protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
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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