Portal de investigación
Estudio en fase I/II, abierto, de seguridad, tolerabilidad, farmacocinética y actividad antitumoral de repotrectinib en pacientes pediátricos y adultos jóvenes con tumores avanzados o metastásicos con reordenaciones de ALK, ROS1 o NTRK1-3 (CARE).
Datos básicos
- Código:
- TPX-0005-07
- Protocolo:
- TPX-0005-07
- EUDRACT:
- 2019-003055-11
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2023
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: Estudio Fase 2 • Determinar la actividad antitumoral de repotrectinib en pacientes pediátricos y adultos jóvenes con neoplasias malignas avanzadas o metastásicas con alteraciones de ALK, ROS1 o NTRK1-3. Objetivos Secundarios: • Determinar la actividad antitumoral en cuanto a DR, supervivencia global (SG) y supervivencia sin progresión (SSP) tras el tratamiento con repotrectinib • Determinar la actividad antitumoral intracraneal de repotrectinib • Evaluar la seguridad y tolerabilidad de repotrectinib en la DRF2 para pacientes pediátricos • Confirmar la FC de repotrectinib con la DRF2 para pacientes pediátricos
Documentos
- No hay documentos
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.
Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.12.007. 2025
A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.
Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose
Article. 10.3390/ijms25042112. 2024
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
Benefits of physical activity self-monitoring in patients with haemophilia: a prospective study with one-year follow-up.
Pérez-Alenda S; (...); Núñez-Cortés R
Article. 10.1111/hae.14988. 2024
Cost-effectiveness and cost-utility analysis of haemate-P versus other von willebrand disease treatments in Spain.
Megias-Vericat, Juan E; (...); Yan, Songkai
Article. 10.1080/13696998.2025.2474886. 2025
Delving into the clinical impact of NETs in pediatric cancer.
Benavent N; (...); Medina P
Article. 10.1038/s41390-024-03437-4. 2024
Development and testing of a mobile app for systematic collection of patient-reported outcomes (PROs) in patients with hemophilia.
Megias-Vericat, J E; (...); Poveda Andres, J L
Letter. 10.1016/j.thromres.2024.109122. 2024
Drug-drug interactions associated with FLT3 inhibitors for acute myeloblastic leukemia: current landscape.
Solana-Altabella, Antonio; (...); Montesinos, Pau
Article. 10.1080/17512433.2023.2174523. 2023
ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer.
Juan-Ribelles A; (...); Fernández-Teijeiro A
Article. 10.1007/s12094-024-03445-0. 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
Incidence and Risk Factors for Development of Cardiac Toxicity in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia
Boluda, Blanca; (...); Montesinos, Pau
Article. 10.3390/cancers15082267. 2023
Mental, emotional and social dimensions of quality of life and their relationship with physical and functional status in adults with haemophilia.
Rodríguez MA; (...); Chimeno-Hernández A
Article. 10.1016/j.thromres.2024.109181. 2024
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
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
Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.
Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis
Article. 10.3390/ijms26041760. 2025
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
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