Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Day One Biopharmaceuticals, Inc. (Voir sur ClinicalTrials)
février 2023
juin 2031
21 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:10 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Samuel ABBOU | 06/10/2026 18:55:04 | Contacter | ||
Critères
Tous
- Less than 25 years of age with LGG harboring a documented known activating RAF
alteration, as identified through molecular assays performed at Clinical Laboratory
Improvement Amendments (CLIA) or other similarly certified laboratories.
- Histopathologic diagnosis of glioma or glioneuronal tumor.
- At least one measurable T2/FLAIR lesion that can be reproducibly measured in at
least 2 dimensions of at least 10 millimetres (mm), visible on 2 or more axial
slices that are preferably, at most, 5 mm apart with 0-mm skip.
- Meet indication for first-line systemic therapy.
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, (even if
histologically low-grade) including but not limited to any of the following: 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) via genetic
testing or current diagnostic clinical criteria.
- Prior or ongoing nonsurgical anticancer therapy for this indication (eg,
chemotherapy, oral/IV targeted therapy) including radiation.