Portal de investigación
ESTUDIO ABIERTO, MULTICÉNTRICO FASE 1/2 DE SURUFATINIB EN COMBINACIÓN CON GEMCITABINA EN PACIENTES PEDIÁTRICOS, ADOLESCENTES Y ADULTOS JÓVENES CON TUMORES SÓLIDOS RECURRENTES O REFRACTARIOS.
Datos básicos
- Código:
- 2020-012-GLOB2
- Protocolo:
- 2020-012-GLOB2
- EUDRACT:
- 2021-003602-41
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2022
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: Parte 1 Determinar la DMT o la dosis recomendada para la fase II (DRF2) del surufatinib y evaluar la seguridad y la tolerabilidad del surufatinib en combinación con la gemcitabina en pacientes pediátricos con tumores sólidos o linfoma recurrentes o refractarios Parte 2 Evaluar la TCE en pacientes pediátricos con osteosarcoma y la TRO en pacientes pediátricos con sarcoma de Ewing y RMS, SPBNR y otros tipos de tumores según los datos que se obtengan en la parte 1 del estudio, cuando se tratan con la combinación de surufatinib y gemcitabina Objetivos Secundarios: Parte 1 Caracterizar la FC de surufatinib en monoterapia y en combinación la gemcitabina en pacientes pediátricos. Documentar la exposición FC de la gemcitabina cuando se usa en combinación con el surufatinib. Evaluar la actividad antitumoral de surufatinib en combinación con gemcitabina en pacientes pediátricos. Aceptabilidad y agradabilidad de surufatinib en suspensión oral. Parte 2 Evaluar otra actividad antitumoral de la combinación de surufatinib y gemcitabina en pacientes pediátricos según datos que se obtengan en la parte 1 del estudio. Evaluar la seguridad y la tolerabilidad de surufatinib en combinación con gemcitabina en pacientes pediátricos según datos que se obtengan en la parte 1 . Caracterizar la FC del surufatinib y en combinación con gemcitabina en pacientes pediátricos según datos que se obtengan en la parte 1 . Documentar la exposición FC de gemcitabina cuando se usa en combinación con surufatinib. Aceptabilidad y agradabilidad de surufatinib en suspensión oral
Documentos
- No hay documentos
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[[Tranaslated article]]Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.
López DF; (...); Ortiz-Romero, P. L.
Article. 10.1016/j.ad.2022.11.013. 2023
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[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
[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.
Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.09.006. 2024
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 multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
A practical solution to estimate the sample size required for clinical prediction models generated from observational research on data
Baeza-Delgado, Carlos; (...); Marti-Bonmati, Luis
Article. 10.1186/s41747-022-00276-y. 2022
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
Amyloid brain-dedicated PET images can diagnose Alzheimer's pathology with Centiloid Scale.
Gandia-Ferrero MT; (...); Martí-Bonmatí L
Article. 10.1016/j.ejmp.2024.103345. 2024
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Clinical experience of whole body and tumour dosimetry of 131-I-mIBG treatment for pediatric patients
Espallardo, I. Torres; (...); Prado-Wohlwend, S.
Meeting Abstract. 2023
ComBat harmonization in different PET imaging scenarios
Gandia-Ferrero, M.; (...); Marti-Bonmati, L.
Meeting Abstract. 2023
Comparative Multicentric Evaluation of Inter-Observer Variability in Manual and Automatic Segmentation of Neuroblastic Tumors in Magnetic Resonance Images
Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis
Article. 10.3390/cancers14153648. 2022
Comparison of protocols with respiratory-gated (4D) motion compensation in PET/CT: open-source package for quantification of phantom image quality.
Martinez-Movilla, Andrea; (...); Carles, Montserrat
Article. 10.1186/s40658-022-00509-4. 2022
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
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
Delving into the clinical impact of NETs in pediatric cancer.
Benavent N; (...); Medina P
Article. 10.1038/s41390-024-03437-4. 2024
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
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
Free automatic software for quality assurance of computed tomography calibration, edges and radiomics metrics reproducibility.
Saborido-Moral, Juan D.; (...); Carles, Montserrat
Article. 10.1016/j.ejmp.2023.103153. 2023
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Imaging biomarkers and radiomics in pediatric oncology: a view from the PRIMAGE (PRedictive In silico Multiscale Analytics to support cancer personalized diaGnosis and prognosis, Empowered by imaging biomarkers) project.
Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis
Article. 10.1007/s00247-023-05770-y. 2023
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
Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.
Pozo-Rosich P; (...); Irimia P
Article. 10.1186/s10194-024-01747-w. 2024
Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.
Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula
Article. 10.3390/antibiotics13080706. 2024
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
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
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
Objective Image Quality Comparison Between Brain-Dedicated PET and PET/CT Scanners.
Gandia-Ferrero MT; (...); Martí-Bonmatí L
Article. 10.1007/s10916-023-01984-7. 2023
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
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT
Flores-Moreno, S.; (...); Gil, A.
Meeting Abstract. 2024
Overall survival prediction and risk stratification in patients with neuroblastoma through machine learning in the large multi-institutional PRIMAGE cohort.
Lozano-Montoya, Jose; (...); Alberich-Bayarri, Angel
Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.10054. 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
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.
Falkenhain-Lopez, D; (...); Ortiz-Romero, P L
Article. 10.1016/j.ad.2022.11.010. 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
Quantitative evaluation of a non-CT based attenuation correction method for a new dedicated brain PET
Gandia-Ferrero, M.; (...); Marti-Bonmati, L.
Meeting Abstract. 2022
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
RE-IRRADIATION FOR PROGRESSIVE DIFFUSE INTRINSIC PONTINE GLIOMA (DIPG): THE SPANISH EXPERIENCE
Panizo, Elena; (...); Lassaletta, Alvaro
Meeting Abstract. 10.1093/neuonc/noae064.116. 2024
Relationship between neuroimaging and emotion recognition in Mild Cognitive Impairment patients.
Gandia-Ferrero, Maria Teresa; (...); Marti-Bonmati, Luis
Article. 10.1016/j.bbr.2023.114844. 2024
Reproducibility Analysis of Radiomic Features on T2-weighted MR Images after Processing and Segmentation Alterations in Neuroblastoma Tumors.
Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis
Article. 10.1148/ryai.230208. 2024
Results of a survey on the treatment of adolescents and young adult (AYA) sarcoma patients in Spain at present time.
Mata Fernandez, Cristina; (...); Morales CV
Article. 10.1007/s12094-022-02912-w. 2022
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
Sequential treatment of High-risk Neuroblastoma combining I-131 MIBG high-dose and Topotecan. First experience
Orrego, N.; (...); Bello-Arques, P.
Meeting Abstract. 2023
State of the art and future perspectives of new radionuclides in Nuclear Medicine.
Rosales, J J; (...); Quincoces, G
Article. 10.1016/j.remnie.2025.500082. 2025
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
Badia, Xavier; (...); Valles, Joan-Antoni
Article. 10.1186/s13023-024-03324-5. 2024
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Use of [(18)F]fluorocholine PET/CT in the detection of primary hyperparathyroidism in paediatrics: a case report.
Martínez Sánchez H; (...); Sánchez Vañó R
Case Reports. 10.1515/jpem-2023-0556. 2024
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023
Y-90 PET/MR imaging optimization with a Bayesian penalized likelihood reconstruction algorithm.
Calatayud-Jordan, Jose; (...); Torres-Espallardo, Irene
Article. 10.1007/s13246-024-01452-7. 2024