- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00121732
An Open-Label Study of E7974 Administered on Days 1, 8, and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies
29 de junio de 2015 actualizado por: Eisai Inc.
A Phase 1, Two-Arm, Open-Label Study of E7974 Administered on Days 1, 8, and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a two-arm, open-label, non-randomized, dose-escalation study to determine the MTD of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists.
Response and progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Tipo de estudio
Intervencionista
Inscripción (Actual)
39
Fase
- 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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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- CTRC
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for entry into the study:
- Patients must have a pathologically diagnosed, histologically or cytologically confirmed solid tumor that has progressed following effective therapy or for which no effective therapy exists (including surgery or radiation therapy).
- Patients must be >= 18 years of age.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
- Patients must have a life expectancy of >= 3 months.
- Patients must have adequate renal function as evidenced by serum creatinine <= 1.5 mg/dL or creatinine clearance >= 40 mL/minute (min).
- Patients must have adequate bone marrow function as evidenced by absolute neutrophil count >= 1,500/µL, hemoglobin of >= 9 g/dL (may be transfused), and platelet count (not transfused) >= 100,000/µL.
- Patients must have adequate liver function as evidenced by bilirubin <= 1.5 mg/dL and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 times the upper limits of normal (ULN), unless related to liver involvement by tumor, in which case <= 5.0 times ULN.
- Patients must be willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study.
- Patients must be willing and able to undergo blood draw and urine sampling for PK in Cycle 1.
- Patients may have either measurable or non-measurable disease.
Exclusion Criteria:
The presence of one or more of the following criteria will disqualify a patient from enrollment in the study:
- Patients who have received chemotherapy within three weeks of E7974 treatment start (6 weeks for a nitrosourea).
- Patients who have not recovered from any chemotherapy-related or other therapy-related toxicity to <= Grade 1 at study entry (excluding Grade 2 alopecia).
- Patients who have received radiotherapy <= 3 weeks prior to study enrollment, whose marrow exposure has exceeded 25% and who have not recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia).
- Patients who have had major surgery without full recovery or major surgery within three weeks of E7974 treatment start.
- Patients with primary brain tumors or metastasis at study entry must have controlled them for >= 1 month by previous treatment, including radiation therapy and corticosteroids.
- Women who are pregnant or breastfeeding.
- Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test.
- Women of childbearing potential unless (1) surgically sterile, (2) physiologically postmenopausal for > 12 months, or (3) using adequate measures (including barrier methods) of contraception.
- Fertile men or their partners who are not willing to use contraception.
- Patients who have a positive history for Human Immunodeficiency Virus (HIV) and/or have active hepatitis B or active hepatitis C at study entry.
- Patients with severe, uncontrolled intercurrent illness or infection.
- Patients with medically uncontrolled cardiovascular illness defined as unstable angina, >= symptomatic Grade II New York Heart Association (NYHA) Classification congestive heart failure (CHF), or myocardial infarction within six months prior to study entry.
- Patients who have received organ allografts requiring immunosuppressive therapy.
- Patients who have received investigational drugs including immunotherapy, gene therapy, hormone therapy, biologic therapy, or chemotherapy within the three-week period prior to E7974 treatment start; patients must have recovered from any previous major therapy-related toxicities (Grade 3 or 4) to <= Grade 1 at study entry.
- Patients with a current history of peripheral neuropathy > CTC Grade 2 (e.g., diabetic or chemotherapy-induced neuropathy).
- Patients with a history of uncontrolled seizures.
- Patients with marked baseline prolongation of QT/QTc interval (QTc interval >470) using the Fridericia method as the main method of QTc analysis.
- Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study.
- Patients with allergy or hypersensitivity to hemiasterlin based product or analogue.
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: A
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Maximum tolerated dose = 0.15 mg/m^2 administered on Days 1, 8, 15 of 28-day cycle.
Maximum tolerated dose = 0.37 mg/m^2 administered on Days 1 and 8 of 21-day cycle.
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Experimental: B
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Maximum tolerated dose = 0.15 mg/m^2 administered on Days 1, 8, 15 of 28-day cycle.
Maximum tolerated dose = 0.37 mg/m^2 administered on Days 1 and 8 of 21-day cycle.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Determine the maximum tolerated dose of E7974 in patients with solid malignancies.
Periodo de tiempo: Duration of each cycle will be 28 or 21 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.
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Duration of each cycle will be 28 or 21 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
1) Assess E7974 for safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD); 2) Evaluate the correlation of AUC with clinical toxicity and efficacy in both arms.
Periodo de tiempo: Duration of each cycle will be 28 or 21 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.
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Duration of each cycle will be 28 or 21 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Jenny Zhang, M.D., Eisai Inc.
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
1 de julio de 2005
Finalización primaria (Actual)
1 de octubre de 2009
Finalización del estudio (Actual)
1 de octubre de 2009
Fechas de registro del estudio
Enviado por primera vez
15 de julio de 2005
Primero enviado que cumplió con los criterios de control de calidad
20 de julio de 2005
Publicado por primera vez (Estimar)
21 de julio de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
1 de julio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
29 de junio de 2015
Última verificación
1 de junio de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E7974-A001-101
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. .
Ensayos clínicos sobre Solid Tumor Malignancies, Cancer
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Hummingbird BioscienceReclutamientoCancer de pancreas | Cáncer de pulmón de células no pequeñas | Tumor sólido metastásico | Tumor sólido localmente avanzadoAustralia
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HistoSonics, Inc.ReclutamientoCancer de RIÑON | Neoplasias Renales | Cáncer renal | Tumor | Tumor Sólido | Tumor BenignoReino Unido
-
Frontier Medicines CorporationReclutamientoCáncer colonrectal | Cancer de pancreas | Cáncer de pulmón de células no pequeñas | Tumor sólido metastásico | Tumor Sólido, Adulto | Tumor sólido irresecable | KRAS G12C | Tumores sólidos avanzados con mutaciones KRAS G12CEstados Unidos
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RedHill Biopharma LimitedMedical University of South Carolina; National Cancer Institute (NCI); FDA Office... y otros colaboradoresTerminadoCancer de pancreas | Tumor sólido adulto no especificado, protocolo específicoEstados Unidos
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Keymed Biosciences Co.LtdReclutamientoCáncer gástrico | Cancer de pancreas | Tumor sólido avanzado | Adenocarcinoma de la unión gastroesofágicaPorcelana
Ensayos clínicos sobre E7974
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Eisai Inc.TerminadoCáncer, Tumores MalignosEstados Unidos
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Eisai Inc.TerminadoCáncer, Tumores MalignosEstados Unidos