Estudio de escalada de dosis y de ampliación para evaluar la seguridad y la eficacia de XL092 en combinación con fármacos inmunoncológicos en pacientes con tumores sólidos avanzados o metastásicos irresecables.

Datos básicos

Protocolo:: XL092-002
EUDRACT:: 2021-004855-18
NCT:
Centro:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:: 2023
Año de finalización:

ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Los objetivos de la etapa de aumento escalonado de la dosis son determinar la dosis recomendada (DR) y evaluar la seguridad, tolerabilidad, farmacocinética (FC), inmunogenicidad y farmacodinámica de XL092 en combinación con los agentes inmuno-oncológicos nivolumab (doblete) y nivolumab + ipilimumab (triplete) en pacientes con cáncer avanzado. Los objetivos de la etapa de ampliación son evaluar la eficacia preliminar de XL092 en monoterapia y en pautas de tratamiento combinado en cohortes específicas del tumor, determinar la seguridad de las pautas de tratamiento combinado, determinar la contribución de los componentes del tratamiento y seguir evaluando la FC plasmática de XL092 administrado por vía oral a diario en monoterapia o en tratamiento combinado en pacientes con cánceres genitourinarios avanzados. Objetivos Secundarios: No aplica

Documentos

No hay documentos

Participantes

Carmina Rodrigo Jarque

Data Manager / Study Coordinator
Irene Torres Espallardo

Investigador Colaborador
Regina Gironés Sarrió

Investigador Principal
Paula Irene Petruskevicius Fernández

Data Manager / Study Coordinator
Consuelo Olivas Arroyo

Investigador Colaborador
José Luis Poveda Andrés

Investigador Colaborador
Stephan Guillermo Prado Wohlwend

Investigador Colaborador
Maria Perez Fernandez

Técnico Apoyo Investigación
Gema Gimeno Mateu

Data Manager / Study Coordinator
Alba Torres Martínez

Investigador Colaborador
Jose Fernando Melo Villamarin

Investigador Colaborador
Sonia Gines Cardenas

Investigador Colaborador
Africa Almendros Riaza

Investigador Colaborador
Basilio Mateo Quiñonero

Investigador Colaborador
Oussama Bardouz Gouguasse

Investigador Colaborador
Maria Del Pilar Morcillo Toledo

Investigador Colaborador
Jaime Castella Malondo

Investigador Colaborador
Cristina Ferrando Juan

Investigador Colaborador
Ana Maria Llorca Ibañez

Data Manager / Study Coordinator

Ver todos los Investigadores

Grupos

Investigación Clínica y Traslacional en Cáncer

Leader

José Gómez Codina
Investigacion Biomédica en Imagen (GIBI 2-30)

Investigador Principal

Leonor Cerdá Alberich
Unidad Mixta de Investigación en Endocrinología, Nutrición y Dietética clínica

Leader

Juan Francisco Merino Torres
Núcleo de investigación traslacional integrado Urológico de Valencia (NITIUV)

Leader

César David Vera Donoso
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Financiadores - Promotores

EXELIXIS, INC.

Resultados del Ensayo Clínico

Publicaciones en Revistas 67

[[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] 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 combined analysis of two prospective randomised studies exploring the impact of extended post-radiation temozolomide on survival outcomes in newly diagnosed glioblastoma (Dec, 10.1007/s11060-023-04513-1, 2023)

Gately L; (...); Balana C

Correction. 10.1007/s11060-024-04581-x. 2024

A combined analysis of two prospective randomised studies exploring the impact of extended post-radiation temozolomide on survival outcomes in newly diagnosed glioblastoma.

Gately, L.; (...); Balana, C.

Article. 10.1007/s11060-023-04513-1. 2023

A COMBINED ANALYSIS OF TWO RANDOMISED STUDIES EXPLORING THE IMPACT OF EXTENDED POST-RADIATION TEMOZOLOMIDE ON SURVIVAL OUTCOMES IN NEWLY DIAGNOSED GLIOBLASTOMA

Gately, Lucy; (...); Balana, Carmen

Meeting Abstract. 2023

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

Addressing the challenges of cancer care in older adults: The unique benefits of oncogeriatric evaluation and management.

Martinez-Peromingo, Javier; (...); Girones, Regina

Letter. 10.1016/j.regg.2023.03.002. 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

Bladder Preservation with Durvalumab plus Tremelimumab and Concurrent Radiotherapy in Patients with Localized Muscle-Invasive Bladder Cancer (IMMUNOPRESERVE): A Phase II Spanish Oncology GenitoUrinary Group Trial.

Garcia-Del-Muro, Xavier; (...); Alemany, Ramon

Article. 10.1158/1078-0432.CCR-24-2636. 2025

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

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

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

Expert consensus to optimize the management of older adult patients with advanced EGFR-mutated non-small cell lung cancer.

Nadal E; (...); Gironés R

Article. 10.1007/s12094-023-03286-3. 2023

Exploring management and outcomes of elderly patients with glioblastoma using data from two randomised trials (GEINO1401/EX-TEM).

Gately L; (...); Balana C

Article. 10.1007/s11060-024-04668-5. 2024

Final database lock results of the phase 2 cohort of lenvatinib plus pembrolizumab for progressive disease after a PD-1/PD-L1-containing therapy in metastatic clear cell renal cell carcinoma

Lee, Chung-Han; (...); Motzer, Robert J.

Meeting Abstract. 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

Glasdegib in combination with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma: Phase Ib/II GEINO 1602 trial

Vaz, M. A.; (...); Girones, R.

Meeting Abstract. 10.1016/j.annonc.2023.09.1695. 2023

How can artificial intelligence optimize value-based contracting?

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

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

Impact of a comprehensive geriatric assessment to manage elderly patients with locally advanced non-small-cell lung cancers: a multicenter prospective study.

Rondan, Maria Arnal; (...); Sarrio, Regina Girones

Article. 10.1007/s12094-024-03657-4. 2024

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

Leave no one behind: A global survey of the current state of geriatric oncology practice by SIOG national representatives.

Mizutani, Tomonori; (...); Kanesvaran, Ravindran

Article. 10.1016/j.jgo.2024.101709. 2024

Lenvatinib plus Pembrolizumab Following Immune Checkpoint Inhibitor Treatment in Patients with Metastatic Clear Cell Renal Cell Carcinoma: Results from Study 111/KEYNOTE-146.

Lee, Chung-Han; (...); Motzer, Robert J

Letter. 10.1016/j.eururo.2024.05.003. 2024

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

P25.03.B RWD OF IDH MUTANT GLIOMAS IN SPAIN, A RETSINE - GEINO STUDY

Mazariegos, M.; (...); Pineda, E.

Meeting Abstract. 10.1093/neuonc/noae144.446. 2024

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

Phase II trial evaluating olaparib maintenance in patients with metastatic castration resistant prostate cancer (mCRPC) after docetaxel treatment, reaching partial or stable response: SOGUG-IMANOL study.

Juan Fita, Maria Jose; (...); Heras, Lucia

Meeting Abstract. 2023

Phase II Trial Evaluating Olaparib Maintenance in Patients with Metastatic Castration-Resistant Prostate Cancer Responsive or Stabilized on Docetaxel Treatment: SOGUG-IMANOL Study.

Juan Fita, Maria Jose; (...); Angel Climent, Miguel

Article. 10.3390/cancers15215223. 2023

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 role of geriatric assessment (GA) in patients with metastatic prostate cancer (MPCaP) attended in medical oncology.

Girones, Regina, Arnal, Maria, Forcano, Silvia

Meeting Abstract. 2023

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

Response to targeted radionuclide therapy with [131I]MIBG AND [177Lu]Lu-DOTA-TATE according to adrenal vs. extra-adrenal primary location in metastatic paragangliomas and pheochromocytomas: A systematic review.

Prado-Wohlwend, Stefan; (...); Merino-Torres JF

Article. 10.3389/fendo.2022.957172. 2022

Same-day comparative protocol PET/CT-PET/MRI [68Ga]Ga-DOTA-TOC in paragangliomas and pheochromocytomas: an approach to personalized medicine.

Prado-Wohlwend, Stefan; (...); Merino-Torres, Juan Francisco

Article. 10.1186/s40644-023-00521-6. 2023

SOGUG-AVELUMAB_RWD: Comprehensive analysis of real-word data to evaluate the effectiveness and safety of avelumab maintenance therapy in patients with stage IV urothelial carcinoma conducted in Spain.

Juan Fita, Maria Jose; (...); Molina Diaz, Aurea

Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.e1656. 2024

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

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

Estudio de escalada de dosis y de ampliación para evaluar la seguridad y la eficacia de XL092 en combinación con fármacos inmunoncológicos en pacientes con tumores sólidos avanzados o metastásicos irresecables.

Datos básicos

Objetivos del proyecto

Documentos

Participantes

Grupos

Financiadores - Promotores

Resultados del Ensayo Clínico

Campos de Estudio

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