Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title

Status

 

LOGGIC/FIREFLY-2 - 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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More information

LOGGIC/FIREFLY-2 - 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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Diagnosis	Low-grade Glioma	Study Status	Open
Phase	III
Age	up to 25 Years	Randomisation	YES
Line of treatment	First line treatment
Routes of Treatment Administration	Experimental: Arm #1 - Tovorafenib (DAY101), oral
Last Posted Update	2024-05-31
ClinicalTrials.gov #	NCT05566795

International Sponsor

Sponsor:
Day One Biopharmaceuticals, Inc.

Collaborator:
SIOPe Brain Tumor Group LOGGIC Consortium

Principal Investigators for Canadian Sites

The Hospital for Sick Children

Centres

The Hospital for Sick Children

Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

 

This is a Phase 3 study to evaluate how safe and effective a drug called tovorafenib is when compared to standard of care chemotherapy. This study is for patients with low-grade glioma (LGG) who have a genetic mutation called a RAF alteration. 

Inclusion Criteria

• Patients must be under 25 years of age to participate
• Must have a diagnosis of a low grade glioma that has RAF alteration 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.