- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00226005
PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
Phase II Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.
The purpose of this research study is to find out if an experimental drug called PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer.
In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the growth of new blood vessels. A drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rarely, it might be possible to stop tumor growth without harming normal tissues.
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259
- Scottsdale Healthcare
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Tucson, Arizona, Estados Unidos, 85724
- University of Arizona/Arizona Cancer Center
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California
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Beverly Hills, California, Estados Unidos, 90211-18500
- Tower Hematology Oncology Medical Group
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231
- Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55407
- Virginia Piper Cancer Institute/Abbott Northwestern Hospital
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Research Institute
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- South Texas Oncology and Hematology
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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:
- Age > 18
- Zubrod performance status of 0 - 2
- Histological or cytological diagnosis of pancreatic adenocarcinoma
- Measurable or evaluable disease determined as per RECIST criteria
- Life expectancy > 12 weeks
- Written informed consent
- Patients must have failed or progressed on prior gemcitabine-based therapy for advanced or metastatic disease.
Exclusion Criteria:
- Islet cell or neuroendocrine carcinomas of the pancreas.
- History or presence of central nervous system disease.
- Patients with a history of another primary malignancy < 5 years
- Prior chemo therapy < 21 days prior to registration.
- Prior biologic or immunotherapy < 14 days prior to registration
- Prior full field radiotherapy < 28 days or limited field radiotherapy < 14 days prior to registration.
- Major surgery < 28 days prior to registration.
- Patients who have received investigational drugs < 28 days prior to registration.
- Prior therapy with anti-VEGF agents.
- Pleural effusion or ascites that causes respiratory compromise.
- Female patients who are pregnant or breast feeding.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Vatalanib
Administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
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One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
Periodo de tiempo: DSMC Schedule
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The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives. Safety Issue: the only endpoint/outcome measure that was a safety issue was the second one (safety and tolerability of PTK) |
DSMC Schedule
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To assess the response rates of patients treated with PTK787/ZK222584.
Periodo de tiempo: DSMC Schedule
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The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.
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DSMC Schedule
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To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients.
Periodo de tiempo: DSMC Schedule
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The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.
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DSMC Schedule
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To perform analysis of tissue, blood and plasma markers that may be helpful in assessing the likelihood of benefit from PTK787/ZK222584 therapy.
Periodo de tiempo: DSMC Schedule
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The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.
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DSMC Schedule
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tomislav Dragovich, MD, PhD, University of Arizona/Arizona Cancer Center
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
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PCRT04-001
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 PTK787/ZK222584
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University of HelsinkiBayerTerminado
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David Rizzieri, MDNovartis PharmaceuticalsTerminadoLinfoma De Células Grandes DifusoEstados Unidos
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University of Michigan Rogel Cancer CenterNovartisTerminado
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George Albert FisherNovartisTerminadoCancer de pancreasEstados Unidos
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Beth Israel Deaconess Medical CenterRambam Health Care Campus; Dana-Farber Cancer Institute; United States Department... y otros colaboradoresActivo, no reclutandoMieloma múltipleEstados Unidos, Israel
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)TerminadoMesotelioma malignoEstados Unidos
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NovartisTerminadoDegeneración macular húmeda relacionada con la edadAustralia, Estados Unidos
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Northwestern UniversityNovartisTerminadoSarcoma | Tumores cerebrales y del sistema nervioso centralEstados Unidos
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Novartis PharmaceuticalsTerminadoEnfermedad de Von Hippel-Lindau | Hemangioblastoma de retina | Hemangioblastoma del SNCEstados Unidos
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)TerminadoSíndromes mielodisplásicos | Leucemia | Neoplasias mielodisplásicas/mieloproliferativasEstados Unidos