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- Estudio de fase 1/2, abierto, de aumento escalonado de la dosis para evaluar la seguridad, la tolerabilidad, la eficacia preliminar y la farmacocinética de TAK-981 en pacientes adultos con tumores sólidos avanzados o metastásicos o con neoplasias malignas hematológicas recidivantes/resistentes.
Estudio de fase 1/2, abierto, de aumento escalonado de la dosis para evaluar la seguridad, la tolerabilidad, la eficacia preliminar y la farmacocinética de TAK-981 en pacientes adultos con tumores sólidos avanzados o metastásicos o con neoplasias malignas hematológicas recidivantes/resistentes.
Dades bàsiques
- Protocol:
- TAK-981-1002
- EURDRACT:
- 2020-003947-27
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2022
- Any de finalització:
- 2023
Objectius del projecte
Objetivo Principal: Fase 1: Determinar la seguridad y la tolerabilidad de TAK-981 en monoterapia en pacientes con tumores sólidos y linfomas avanzados o metastásicos. Determinar la DRF2 de TAK-981. Fase 2: Evaluar la eficacia preliminar de TAK-981 en pacientes con determinadas indicaciones de tumores sólidos o LNH CD20+ recidivante/resistente. Objetivos Secundarios: Fase 1: •Evaluar la actividad antitumoral preliminar de TAK-981. •Evaluar la actuación sobre la diana de TAK-981 (formación de aductos de SUMO-TAK-981) y la inhibición de la vía de SUMOilación en células de la piel y de sangre periférica. •Caracterizar el perfil FC de TAK-981. Fase 2: •Evaluar la eficacia de TAK-981 en determinadas indicaciones de tumores sólidos y LNH CD20+, determinada mediante la tasa de respuesta global (TRG), el tiempo hasta la respuesta (THR), la duración de la respuesta (DR), la tasa de control de la enfermedad (TCE), el tiempo hasta la progresión (THP) y la supervivencia sin progresión (SSP). •Evaluar la supervivencia global (SG). •Evaluar la seguridad y la tolerabilidad de TAK-981. •Obtener datos de concentración plasmática-tiempo de TAK-981.
Documents
- No hi ha documents
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
[[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
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
Accuracy and prognostic impact of FDG PET/CT and biopsyin bone marrow assessment of follicular lymphomaat diagnosis: A Nation-Wide cohort study.
Rodenas-Quinonero, Isabel; (...); Ortuno, Francisco Jose
Article. 10.1002/cam4.5424. 2022
Artificial Intelligence on FDG PET Images Identifies Mild Cognitive Impairment Patients with Neurodegenerative Disease.
Prats-Climent, Joan; (...); Marti-Bonmati, Luis
Article. 10.1007/s10916-022-01836-w. 2022
CA125: a new biomarker in patients with Fontan circulation.
Fuentes, Francisco Buendia; (...); Soriano, Joaquin Rueda
Article. 10.1016/j.rec.2022.05.029. 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
Cytokine response as a biomarker for early diagnosis and outcome prediction of stem cell transplant recipients and acute leukemia patients with invasive aspergillosis.
Puerta-Alcalde, Pedro; (...); Garcia-Vidal, Carolina
Article. 10.1093/mmy/myac038. 2022
Chronic liver disease-associated severe thrombocytopenia in Spain: Results from a retrospective study using machine learning and natural language processing.
Calleja-Panero, Jose Luis; (...); Gonzalez Calvo, Jose
Article. 10.1016/j.gastrohep.2023.05.010. 2023
Design and Validation of a Custom Next-Generation Sequencing Panel in Pediatric Acute Lymphoblastic Leukemia.
Gil, Jose Vicente; (...); Barragan, Eva
Article. 10.3390/ijms24054440. 2023
Disseminated toxoplasma infection after hematopoietic stem cell transplantation with myositis and encephalitis.
Asensi Cantó P; (...); Guerreiro M
Article. 10.1111/tid.14067. 2023
Does hyaluronidase injected in periocular area change skin ultrastructure?: Standardized in vitro analysis
Aguilar-González M; (...); Pérez-López M
Article. 10.1111/jocd.15014. 2022
Efficacy and Safety of Treatment Venetoclax Monotherapy or Combined with Rituximab in Patients with Relapsed/ Refractory Chronic Lymphocytic Leukemia (CLL) in the Real-World Setting in Spain: An Update of the Venares Study
Ferra, Christelle; (...); Baltasar, Patricia
Meeting Abstract. 10.1182/blood-2022-162186. 2022
Geriatric assessment in hematology scale predicts treatment tolerability in older patients diagnosed with hematological malignancies: The RETROGAH study.
de la Rubia J; (...); Bonanad, Santiago
Article. 10.1016/j.jgo.2022.10.016. 2022
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
IFISTRATEGY: Spanish National Survey of Invasive Fungal Infection in Hemato-Oncologic Patients.
Vallejo, Carlos; (...); Peman, Javier
Article. 10.3390/jof9060628. 2023
Immunobiology of cytomegalovirus infection in patients with haematological malignancies undergoing treatment with small molecule inhibitors.
de la Asuncion Carlos, Solano; (...); Navarro, David
Letter. 10.1111/bjh.18655. 2023
Immunoparesis Recovery in Transplant-Ineligible Newly Diagnosis Multiple Myeloma Patients: An Independent Prognosis Factor That Could Complement Prognostic Value of Minimal Residual Disease
Lakhwani, Sunil; (...); Hernandez, Miguel-Teodoro
Meeting Abstract. 10.1182/blood-2022-166826. 2022
Impact of pre- and/or post-autologous stem cell transplantation exposure to brentuximab vedotin on survival outcomes in patients with high-risk Hodgkin lymphoma.
Martinez, Carmen; (...); Garcia-Sanz, Ramon
Article. 10.1007/s00277-022-05011-6. 2022
Intimal Sarcoma with MDM2/CDK4 Amplification and p16 Overexpression: A Review of Histological Features in Primary Tumor and Xenograft, with Immunophenotype and Molecular Profiling.
Giner, Francisco; (...); Llombart-Bosch, Antonio
Article. 10.3390/ijms24087535. 2023
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
Non-traumatic spontaneous abdominal haemorrhage
Ballesta, M.; (...); Lerga, P. Estelles
Article. 10.1016/j.rx.2022.11.003. 2023
Non-traumatic spontaneous abdominal haemorrhage.
Ballesta M; (...); Estellés Lerga P
Article. 10.1016/j.rxeng.2022.11.004. 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
Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results from a Prespecified Analysis of the Pivotal Phase II Study ELM-2
Kim, Won-Seog; (...); Walewski, Jan
Meeting Abstract. 10.1182/blood-2022-158406. 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
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 Value of Serum Paraprotein Response Kinetics in Patients With Newly Diagnosed Multiple Myeloma.
Tamariz-Amador, Luis-Esteban; (...); Troconiz, Inaki F.
Article. 10.1016/j.clml.2022.04.024. 2022
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
Radioembolization in patients with hepatocellular carcinoma: a series of 53 cases.
Olivan-Sasot, P; (...); Olivas-Arroyo, C
Article. 10.1016/j.rxeng.2021.03.001. 2023
Recovery of Uninvolved Heavy/Light Chain Pair Immunoparesis during Maintenance Is an Independent Prognostic Factor for Multiple Myeloma and Could Complement Prognosis Value of Minimal Residual Disease
Lakhwani, Sunil; (...); Hernandez, Miguel-Teodoro
Meeting Abstract. 10.1182/blood-2022-167247. 2022
SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization
Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis
Article. 10.1111/jcpt.13703. 2022
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 contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.
Gil-Nagel A; (...); Gil A
Article. 10.1016/j.yebeh.2022.108711. 2022