- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00946153
Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)
27 de agosto de 2018 actualizado por: Eisai Co., Ltd.
Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is administered continually once daily in participants with advanced hepatocellular carcinoma.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
66
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Seoul
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Gangnam-gu, Seoul, Corea, república de
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Songpa-gu, Seoul, Corea, república de
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Chiba
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Kashiwa-shi, Chiba, Japón
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Fukuoka
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Kurume-shi, Fukuoka, Japón
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Hokkaido
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Sapporo-shi, Hokkaido, Japón
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Kanagawa
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Kawasaki-shi, Kanagawa, Japón
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Osaka
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Osaka-shi, Osaka, Japón
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Osakasayama-shi, Osaka, Japón
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Saga
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Saga-shi, Saga, Japón
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Tokyo
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Chuo-ku, Tokyo, Japón
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Minato-ku, Tokyo, Japón
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Musashino-shi, Tokyo, Japón
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion criteria:
- Histologically or clinically confirmed diagnosis of advanced HCC.
- Eastern Cooperative Oncology Group-Performance Status (ECOG-PS): 0-1.
- Adequate laboratory values/organ function tests.
Exclusion criteria:
- Simultaneous or metachronous cancers.
- Pericardial, ascites, or pleural effusion requiring drainage.
- Brain metastasis/meningeal carcinomatosis presenting clinical symptoms or requiring treatment.
- Malabsorption syndrome.
- Artery-portal vein shunt or artery-vein shunt preventing proper diagnosis of tumor.
- Use of drugs known to inhibit cytochrome P3A4.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Lenvatinib
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In the Dose-Escalation Component of the study, lenvatinib will be administered as continuous once-daily oral dosing.
Dose-escalation will occur based on safety information obtained during Cycle 1.
The recommended dose for the Expansion Component of the study will use the MTD in Cycle 1.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib
Periodo de tiempo: Up to 28 days (Cycle1)
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The MTD was defined as the highest dose level at which no more than 1 of 6 participants had a dose limiting toxicities (DLT).
DLT was defined as any of the following events: grade 4 or higher hematologic toxicity or grade 3 thrombocytopenia that required blood transfusion, grade 3 or higher nonhematologic toxicity, grade 4 hypertension uncontrolled by antihypertensive drug(s), aspartate aminotransferase/alanine aminotransferase (AST/ALT) greater than (>) 10.0*upper limit of normal (ULN), proteinuria 4+ by urine dipstick, proteinuria 3+ by urine dipstick was to be monitored by 24-hour urine collection, proteinuria >3.5 gram (g) for 24 hours, diarrhea/vomiting/nausea of grade 3 or higher that was uncontrollable despite maximal supportive therapies and abnormal clinical laboratory values that required no treatment, grade 3 proteinuria by dipstick, diarrhea/vomiting/nausea that was managed with supportive therapies were not considered as DLT.
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Up to 28 days (Cycle1)
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Phase 2: Time to Progression (TTP) by Independent Review Assessment
Periodo de tiempo: From day of registration to the day when PD was first confirmed (approximately up to 6.1 years)
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TTP was defined as the time from the date of registration to the date when progressive disease (PD) was first confirmed.
PD was evaluated according to modified response evaluation criteria in solid tumors (mRECIST) by an independent imaging review.
PD was defined as at least a 20 percent (%) increase in the sum of long diameter (LD) of target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 millimeter (mm) (including new lesions).
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From day of registration to the day when PD was first confirmed (approximately up to 6.1 years)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Phase 1: Best Overall Response (BOR) of Lenvatinib by Investigator Assessment
Periodo de tiempo: Every 8 weeks (approximately up to 18.4 months)
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BOR was performed using RECIST1.1 and was measured as complete response (CR) defined as when an overall response of CR was obtained 2 or more consecutive times at intervals of at least 28 days (the date when the second overall response of CR was confirmed and the BOR established as CR was regarded as the "CR confirmed date), partial response (PR) defined as when the overall response of PR or better (CR or PR) was obtained 2 or more consecutive times at intervals of at least 28 days (the date when the second overall response of PR was confirmed and the BOR established as PR will be regarded as the "PR confirmed date), PD defined as when the BOR was neither CR, PR, or stable disease (SD), and the overall response was PD, SD defined as when the BOR obtained was neither CR nor PR, but no PD from the initial administration to the end of Cycle 2 and the overall response of SD or better occurred at least once and not evaluable (NE) was when the overall response was NE in all cases.
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Every 8 weeks (approximately up to 18.4 months)
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Phase 1: Objective Response Rate (ORR) by Investigator Assessment
Periodo de tiempo: From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
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ORR was defined as the percentage of participants who achieved a tumor response measured by RECIST 1.1 of CR defined as disappearance of all target lesions (a short diameter is less than (<)10 mm if it exists in a lymph node) plus PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
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From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
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Phase 1: Disease Control Rate (DCR) by Investigator Assessment
Periodo de tiempo: Up to Week 16
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DCR was measured by RECIST 1.1 and defined as CR which was defined as disappearance of all target lesions (a short diameter was <10 mm if it exists in a lymph node) plus PR which was defined as at least 30% decrease in the sum of the long diameter (hereafter referred to as sum of LD) of all target lesions, as compared with baseline summed LD plus SD which was reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to PD.
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Up to Week 16
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Phase 2: Progression-free Survival (PFS) by Independent Review Assessment
Periodo de tiempo: From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
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PFS was defined as the time from the date of registration until the date when PD was first confirmed or death (whichever occurred first) as determined by mRECIST and PD was defined as at least a 20% increase in the sum of long diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
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From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
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Phase 2: Objective Response Rate (ORR) by Independent Review Assessment
Periodo de tiempo: From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
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ORR was defined as the percentage of participants who achieved a tumor response measured by mRECIST of CR defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node) plus PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
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From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
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Phase 2: Disease Control Rate (DCR) by Independent Review Assessment
Periodo de tiempo: Weeks 8 and 16
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DCR was measured by mRECIST and defined as CR which was defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node) plus PR which was defined as at least 30% decrease in the sum of the long diameter (hereafter referred to as sum of LD) of all target lesions, as compared with baseline summed LD plus SD which was reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to PD.
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Weeks 8 and 16
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Phase 2: Overall Survival (OS)
Periodo de tiempo: From day of registration to the day of death (approximately 6.1 years)
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OS was defined as the time from the date of registration until the date of death.
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From day of registration to the day of death (approximately 6.1 years)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
24 de julio de 2009
Finalización primaria (Actual)
15 de junio de 2014
Finalización del estudio (Actual)
13 de agosto de 2015
Fechas de registro del estudio
Enviado por primera vez
23 de julio de 2009
Primero enviado que cumplió con los criterios de control de calidad
23 de julio de 2009
Publicado por primera vez (Estimar)
24 de julio de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de febrero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2018
Última verificación
1 de julio de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias del Sistema Digestivo
- Enfermedades del HIGADO
- Neoplasias Hepaticas
- Carcinoma
- Carcinoma Hepatocelular
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Lenvatinib
Otros números de identificación del estudio
- E7080-J081-202
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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