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
mars 2030
10 avril 2025
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 | 10/04/2024 08:55:46 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Lutte contre le Cancer - Centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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.