Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05566795 En recrutement IDF

Titre

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

Type

Interventional

Pathologie

Gliome

Phase

Phase 3

Promoteur

Day One Biopharmaceuticals, Inc. (Voir sur ClinicalTrials)

Date de début

février 2023

Date de fin

mars 2030

Dernière mise à jour

10 octobre 2024

Résumé

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.

Détail

Voir le détail Approximately 400 treatment-naïve low-grade glioma patients will be randomized 1:1 to either tovorafenib (Arm 1) or an Investigator's choice of SoC chemotherapy (Arm 2). Arm 1 (tovorafenib): treatment cycles will repeat every 28 days in the absence of disease progression. Patients will continue tovorafenib until any of the following occurs: disease progression based on Response Assessment in Neuro-Oncology (RANO-LGG) criteria, unacceptable toxicity, withdrawal of consent to treatment, or end of study. Arm 2 (Investigator's Choice of SoC Chemotherapy): patients will receive one of 3 SoC chemotherapy options selected by the treating Investigator: Children's Oncology Group - Vincristine/Carboplatin (COG-V/C) regimen, International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C) regimen, or vinblastine (VBL) regimen. The choice of SoC chemotherapy regimen will be selected prior to patient randomization. Treatment will continue until completion of therapy or until any of the following occurs: disease progression based on RANO-LGG criteria, unacceptable toxicity, withdrawal of consent to treatment, or end of study. Patients who discontinue treatment due to disease progression will have (1) radiographic evidence of progressive disease based on RANO-LGG, as determined by the Investigator and confirmed by the IRC, or (2) clinical progression based on RANO-LGG criteria determined by the Investigator. Investigators are encouraged to discuss cases of clinical progression and early radiographic progression without clinical symptom with the Sponsor Medical Monitor prior to treatment discontinuation or initiation of a different form of treatment for the malignancy. Patients may continue therapy beyond progressive disease Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT CURIE		En recrutement IDF	04/09/2024 13:49:40	Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY	Samuel ABBOU	En recrutement IDF	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		En recrutement		Contact (sur clinicalTrials)
Centre Léon Bérard - 69008 - Lyon - France		En recrutement		Contact (sur clinicalTrials)
Hôpital de la Timone - 13005 - Marseille - France		En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT05566795 - 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

Informations générales
Etablissements
Critères
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