LOGGIC/FIREFLY-2
Research type
Research Study
Full 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
IRAS ID
1006139
Contact name
Sandya Raju
Contact email
Sponsor organisation
Day One Biopharmaceuticals, Inc. (Day One)
Eudract number
2022-001363-27
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate if DAY101 is safe, well-tolerated and how well it works compared to Standard of Care (SoC) chemotherapy in treating children, adolescent, and young adult participants with low-grade gliomas with RAF alteration.
Approximately 400 participants across different countries are expected to take part in this study. Participants will be randomly assigned to one of the two treatment groups: DAY101 or SoC chemotherapy. This study consists of a Screening period, a Treatment period, an End of Treatment (EOT) visit, a 30-day Safety Follow-up visit and a Long-Term follow-up period.
Participants may receive DAY101 as long as their tumour does not get worse, they do not have medically unacceptable side effects, or their study doctor determines their condition to be appropriate for this study. Participants may receive SoC chemotherapy for a certain period of time that is commonly consistent with standard medical practice.
Participants will be asked to visit the study clinic approximately every 4 weeks while they are receiving study treatment. Procedures to be performed include physical examinations, collection of vital signs, eye examinations, collection of blood and urine samples, dermatology examinations, electrocardiogram (ECG)s, Echocardiogram (ECHO), Magnetic Resonance Imaging (MRI) scans of the tumour, X-rays and completion of questionnaires.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0178
Date of REC Opinion
14 Jun 2023
REC opinion
Further Information Favourable Opinion