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
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
Grupos
Financiadores - Promotores
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
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
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
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
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
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
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
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
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
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
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
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