- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00326950
Phase I Clinical Study of E7389
Phase I Clinical Study of E7389 in Patients With Solid Tumors
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Chiba-prefecture
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Kashiwa, Chiba-prefecture, Japón, 277-0882
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- Patients with histologically or cytologically confirmed solid tumors.
- Patients who have progressed on or following standard therapy and with no other treatment options.
- Patients aged 20-74 when they give informed consent.
- Patients having a performance status (PS) of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Patients who can stay at the hospital from the start of the study drug treatment to 2 weeks of the first cycle.
- Patients having adequate function of major organs (bone marrow, liver, kidney and lungs):
(1) Neutrophil count 1,500/mm3 (2) Platelet count 100,000/mm3 (3) Hemoglobin 9.0 g/dL (4) Aspartate aminotransferase [AST] 2.5 times the upper limits of normal (ULN) in institute, unless related to liver involvement by tumor, in which case 5.0 times ULN (5) Alanine aminotransferase [ALT] 2.5 times ULN in institute, unless related to liver involvement by tumor, in which case 5.0 times ULN (6) Total bilirubin 1.5 times ULN in institute (7) Serum creatinine 1.5 times ULN in institute (8) Pulse oximeter oxygen saturation 90%
7. Patients with no adverse drug reactions (excluding alopecia, etc.) that were caused by the prior therapy or could influence the safety evaluation of the study drug.
The withdrawal periods required from the completion of the prior therapy to the start of the study drug therapy are as follows:
- Chemotherapy (excluding oral 5-FU and molecular target drugs), surgical therapy, other study drugs: 4 weeks
- Nitrosourea agents, mitomycin C: 6 weeks
- Radiotherapy, endocrinotherapy, immunotherapy, oral 5-FU, molecular target drugs, blood transfusion, blood products, G-CSF and other hematopoietic factors: 2 weeks
8. Patients who give written informed consent.
9. Patients with an expected survival of longer than 3 months from the start of the study drug therapy.
Exclusion criteria:
- Patients with systemic infection with a fever (38°C).
- Patients with a large amount of pleural effusion, ascites and pericardial fluid requiring drainage.
- Patients with brain metastasis with clinical symptoms.
- Patients with serious complications: (1) Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension) (2) Patients with myocardial infarction within 6 months prior to study entry (3) Patients with a complication of hepatic cirrhosis (4) Patients with interstitial pneumonia and pulmonary fibrosis (5) Patients with a bleeding tendency
Women who are pregnant or breastfeeding, or premenopausal women of childbearing potential.
Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Premenopausal women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test, or have not agreed to use adequate measures of contraception.
- Fertile men who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception.
- Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus surface antigen (HBsAg).
- Patients who need continuous systemic steroid therapy during the study period.
- Patients who need continuous use of phenytoin, carbamazepine, rifampicin and/or barbiturate which induces cytochrome P450 (CYP3A4), a drug-metabolizing enzyme, during the study period.
- Patients who have received extensive radiation therapy (30% or more of bone marrow).
- Patients who refused to receive a supportive therapy of blood transfusion by suppressing bone marrow.
- Patients who are participating in other clinical studies.
- Patients whom the investigator or subinvestigator has judged inappropriate for this study.
Plan de estudios
¿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: 1
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E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle.
The initial dose level will be 0.7 mg/m2, with planned dose levels of 1.0, 1.4, 2.0 mg/m2.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)
Periodo de tiempo: 3 weeks
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DLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)>/=Grade 3 febrile neutropenia, 3)>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to >/=Grade 3 neutropenia or thrombocytopenia or investigator decision.
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3 weeks
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Maximum Tolerated Dose (MTD)
Periodo de tiempo: 3 Weeks
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MTD was the lowest dose at which a dose limiting toxicity occurred.
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3 Weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects.
Periodo de tiempo: 3 weeks
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3 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Tomio Nakamura, Eisai Co., Ltd.
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
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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Ensayos clínicos sobre E7389
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Eisai Inc.TerminadoTumores sólidos avanzadosPaíses Bajos
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Eisai LimitedTerminado
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Eisai Inc.TerminadoSarcoma de tejido blandoFrancia, Alemania, Bélgica, Dinamarca, Polonia
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Eisai Inc.TerminadoCáncerEstados Unidos, Austria, India
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Eisai Co., Ltd.Activo, no reclutando
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Eisai Inc.TerminadoTumor sólido adulto no especificado, protocolo específicoEstados Unidos
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Eisai Inc.Children's Oncology GroupTerminado
-
Eisai Co., Ltd.Terminado
-
National Cancer Institute (NCI)TerminadoCáncer de cabeza y cuelloEstados Unidos
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Eisai Inc.Terminado