Portal de investigación
ESTUDIO DE FASE I DE AUMENTO GRADUAL DE LA DOSIS Y DE COHORTES EXPANDIDO DE PF-06821497 EN EL TRATAMIENTO DE PACIENTES ADULTOS CON CÁNCER DE PULMÓN MICROCÍTICO (CPM) RECIDIVANTE O RESISTENTE, CÁNCER DE PRÓSTATA RESISTENTE A LA CASTRACIÓN (CPRC) Y LINFOMA FOLICULAR (LF)
Datos básicos
- Código:
- C2321001
- Protocolo:
- C2321001
- EUDRACT:
- 2018-001835-37
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2023
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: Parte 1A:Evaluar seguridad y tolerabilidad (SyT) a niveles de dosis en aumento de PF-06821497 en sucesivas cohortes de pacientes(pac.)con CPM, CPRCm y LF, para establecer dosis segura para iniciar partes 1B y 2A. Parte 1B:Evaluar SyT a niveles de dosis en aumento de PF-06821497 en sucesivas cohortes de pac. con LF(monoterapia) Parte 1C:Evaluar SyT a niveles de dosis crecientes de PF-06821497 en cohortes sucesivas de pac. con CPRCm(monoterapia) para determinar la DMT o seleccionar la DRF2. Parte 2A:Evaluar SyT a niveles de dosis en aumento de PF-06821497 en sucesivas cohortes de pac. con CPM en combinación (com.)con quimio. del tratamiento de ref. basada en platino cisplatino o carboplatino con etopósido, y en pac.con CPRCm en com. con enzalutamida (enza) a fin de determinar su DMT y/o (DRF2) Parte 2B:Evaluar SyT a la DRF2 en pac. con CPRCm en com. con enza. Evaluar eficacia de enza +PF-06821497 y de enza en monoterapia sobre la SSPr en pacientes con CPRCm.Más objetivos en protocolo Objetivos Secundarios: - Evaluar el perfil general de seguridad de PF-06821497. Parte 1A, 1B, 1C, 2A, 2B y 2C: Evaluar en más profundidad la actividad antitumoral preliminar de PF-06821497. Parte 1A, 1B y 1C: Caracterizar la farmacocinética (FC) de dosis únicas y múltiples de PF-06821497. Parte 2: Parte 2A: Caracterizar la farmacocinética de dosis únicas y múltiples de PF-06821497 cuando se administra en combinación con enzalutamida en el CPRCm, y en combinación con cisplatino o carboplatino y etopósido en pacientes con CPM. Parte 2B y 2C: Evaluar en mayor profundidad la FC de dosis únicas y múltiples de PF-06821497 cuando se administra en combinación con enzalutamida en pacientes con CPRCm. - Evaluar el impacto de PF-06821497 en combinación con enzalutamida y de enzalutamida en monoterapia sobre los resultados notificados por el paciente. Cohorte del efecto de los alimentos (Parte 1C): Evaluar el efecto de los alimentos sobre la FC de PF-06821497 en pacientes con CPRCm
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] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study.
Segui-Solanes, Carlos; (...); Borras-Blasco, Joaquin
Article. 10.1016/j.farma.2024.08.002. 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
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
Automatic etiological classification of stroke thrombus digital photographs using a deep learning model
Lucero-Garofano, Alvaro; (...); Manjon, Jose V.
Article. 10.3389/fneur.2025.1534845. 2025
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
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
Correction: Update on the management of elderly patients with colorectal cancer.
Soler-González G; (...); Gironés-Sarrió R
Correction. 10.1007/s12094-023-03351-x. 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
DeepCERES: A deep learning method for cerebellar lobule segmentation using ultra-high resolution multimodal MRI.
Morell-Ortega, Sergio; (...); Manjon, Jose V
Article. 10.1016/j.neuroimage.2025.121063. 2025
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
Distal Access Catheter Improves Balloon Guide and Stent Retriever Thrombectomy Outcomes in Nonagenarians.
Puig, Josep; (...); Blasco, Jordi
Article. 10.1111/jon.70012. 2025
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
Enhancing the First-Pass Effect in Acute Stroke: The Impact of Stent Retriever Characteristics
Murias, Eduardo; (...); Vega, Pedro
Article. 10.3390/jcm13113123. 2024
Executive dysfunction and cortical variations among intimate partner violence perpetrators and the association with sexism.
Romero-Martinez, Angel; (...); Moya-Albiol, Luis
Article. 10.1093/scan/nsae046. 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
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
Gray matter volume differences in intimate partner violence perpetrators and its role in explaining dropout and recidivism
Romero-Martinez, Angel; (...); Moya-Albiol, Luis
Article. 10.1016/j.jpsychires.2024.09.019. 2024
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
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
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
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
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
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
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
SEOM-GEINO clinical guidelines for high-grade gliomas of adulthood (2022).
Segura, Pedro Perez; (...); Losada, Estela Pineda
Article. 10.1007/s12094-023-03245-y. 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
SIOG COVID-19 Working Group recommendations on COVID-19 therapeutic approaches in older adults with cancer.
Russo, Chiara; (...); Battisti NML
Article. 10.1016/j.jgo.2023.101564. 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
Spanish cardiac catheterization and coronary intervention registry. 32nd official report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2022).
Jurado-Román A; (...); García de la Borbolla Fernández R
Article. 10.1016/j.rec.2023.07.012. 2023
Spinocerebellar Ataxia 36 is a Frequent Cause of Hereditary Ataxia in Eastern Spain
Baviera-Munoz, Raquel; (...); Bataller, Luis
Article. 10.1002/mdc3.13740. 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
State of the scientific evidence and recommendations for the management of older patients with gastric cancer.
Paredero-Perez, Irene; (...); Girones-Sarrio, Regina
Article. 10.1016/j.jgo.2023.101657. 2023
Strategies to enhance management of HER2-positive breast cancer in the elderly: an expert consensus perspective.
Del Barco, Sonia; (...); Servitja, Sonia
Article. 10.1007/s12094-024-03838-1. 2025
The contribution of brain volume to explain autonomous imbalance during recovery from acute stress in batterers.
Romero-Martinez, Angel; (...); Moya-Albiol, Luis
Letter. 10.1007/s00429-024-02772-w. 2024
The role of intimate partner violence perpetrators' resting state functional connectivity in treatment compliance and recidivism.
Romero-Martinez, Angel; (...); Moya-Albiol, Luis
Article. 10.1038/s41598-024-52443-3. 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
Update on the management of elderly patients with colorectal cancer.
Soler-Gonzalez, Gemma; (...); Girones-Sarrio, Regina
Article. 10.1007/s12094-023-03243-0. 2023
Update on the management of older patients with pancreatic adenocarcinoma: a perspective from medical oncology.
Guillot Morales M; (...); Gironés Sarrió R
Article. 10.1007/s12094-024-03386-8. 2024
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