Estudio de extensión multicéntrico y abierto para evaluar los efectos a largo plazo en pacientes pediátricos tratados con Tafinlar (dabrafenib) y/o Mekinist (trametinib).

Datos básicos

Protocolo:
CDRB436G2401
EUDRACT:
2018-004459-19
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:
2023
Año de finalización:
2023
ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Evaluar el efecto a largo plazo del tratamiento con dabrafenib, trametinib o la combinación de ambos. Objetivos Secundarios: Evaluar el efecto a largo plazo del tratamiento con dabrafenib, trametinib o la combinación de ambos en el estado de salud general, el crecimiento y el desarrollo. Evaluar la eficacia según lo determinado por las pautas estándares del centro.

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

NOVARTIS FARMACEUTICA, S.A.

Resultados del Ensayo Clínico


A randomized, open-label, phase 2 study evaluating abemaciclib in combination with irinotecan and temozolomide in participants with relapsed or refractory Ewing sarcoma

Van Hal, Gertjan; (...); Lewin, Jeremy Howard

Meeting Abstract. 2023


Adolescent cancer care: What has changed in Spain in the past decade?

Garrido Colino, Carmen; (...); Vagace Valero, Jose Manuel

Article. 10.1016/j.anpede.2023.01.003. 2023


Adolescent cancer care: What has changed in Spain in the past decade?

Garrido Colino, Carmen; (...); SEHOP

Article. 10.1016/j.anpedi.2022.09.012. 2023

  • Open Access.

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

  • Open Access.

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023


Delving into the clinical impact of NETs in pediatric cancer.

Benavent N; (...); Medina P

Article. 10.1038/s41390-024-03437-4. 2024


Evaluation of circulating tumor DNA by electropherogram analysis and methylome profiling in high-risk neuroblastomas

Trinidad, Eva Maria; (...); de Mora, Jaime Font

Article. 10.3389/fonc.2023.1037342. 2023

  • Open Access.

High risk neuroblastoma (HR-NB) with MNA and age <18 months: Results from the HR-NBL1/SIOPEN trial

Ladenstein, Ruth Lydia; (...); Canete, Adela

Meeting Abstract. 2023


How can artificial intelligence optimize value-based contracting?

Poveda, Jose Luis; (...); Medrano, Ignacio H.

Letter. 10.1186/s40545-022-00475-3. 2022

  • Open Access.

Independent Validation of a Deep Learning nnU-Net Tool for Neuroblastoma Detection and Segmentation in MR Images

Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis

Article. 10.3390/cancers15051622. 2023

  • Open Access.

Liquidhope: methylome and genomic profiling from very limited quantities of plasma-derived DNA.

Trinidad EM; (...); Font de Mora J

Article. 10.1093/bib/bbac575. 2023

  • Open Access.

National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies

Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis

Meeting Abstract. 10.1182/blood-2022-169938. 2022

  • Open Access.

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

  • Open Access.

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

  • Open Access.

Personalized Medicine in Infant Population with Cancer: Pharmacogenetic Pilot Study of Polymorphisms Related to Toxicity and Response to Chemotherapy.

Urtasun, Andrea; (...); Herrero, Maria Jose

Article. 10.3390/cancers15051424. 2023

  • Open Access.

Prognostic factors of early mortality in children and adolescents enrolled in oncology trials with a dose-finding part in the era of targeted and immune therapies: An Innovative Therapies for Children with Cancer (ITCC) study

Carceller, Fernando; (...); Moreno, Lucas

Meeting Abstract. 2023


Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials.

Kelly, Sarah M.; (...); Mandeville, Henry

Article. 10.1016/j.radonc.2023.109549. 2023

  • Open Access.

Recommended phase 2 dose (RP2D) for abemaciclib in combination with irinotecan (IRN) and temozolomide (TMZ) in pediatric patients with relapsed/refractory solid tumors (JPCS Part A)

Lassaletta, Alvaro; (...); Juan-Ribelles, Antonio

Meeting Abstract. 2023


Safety and PK (pharmacokinetic) profile of niraparib (nir) plus dostarlimab (dost) in pediatric patients (pts) with recurrent or refractory (RR) solid tumors: SCOOP study

Doz, Francois; (...); Rubio-San-Simon, Alba

Meeting Abstract. 2023


Campos de Estudio

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