A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
8 de octubre de 2010 actualizado por: Pfizer
A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
106
Fase
- Fase 2
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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California
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Duarte, California, Estados Unidos, 91010-3000
- Pfizer Investigational Site
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Pasadena, California, Estados Unidos, 91105
- Pfizer Investigational Site
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San Francisco, California, Estados Unidos, 94115
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Pfizer Investigational Site
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Boston, Massachusetts, Estados Unidos, 02115
- Pfizer Investigational Site
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Boston, Massachusetts, Estados Unidos, 02215
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Pfizer Investigational Site
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Pfizer Investigational Site
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New York
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New York, New York, Estados Unidos, 10021
- Pfizer Investigational Site
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New York, New York, Estados Unidos, 10022
- Pfizer Investigational Site
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Pfizer Investigational Site
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Pfizer Investigational Site
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Oregon
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Portland, Oregon, Estados Unidos, 97213
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Pfizer Investigational Site
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- Pfizer Investigational Site
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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:
- Cytokine refractory metastatic renal cell carcinoma with clear cell component
- Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
- Prior nephrectomy
Exclusion Criteria:
- Prior treatment with any systemic therapy other than 1 cytokine therapy
- History of or known brain metastases
- Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start
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: 1
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50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
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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Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)
Periodo de tiempo: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST.
CR defined as disappearance of all target lesions.
PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to Tumor Progression (TTP)
Periodo de tiempo: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first.
TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Duration of Response (DR)
Periodo de tiempo: Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
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Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of patients with a confirmed objective tumor response. |
Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
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Overall Survival (OS)
Periodo de tiempo: From start of study treatment until death
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Time in weeks from the start of study treatment to date of death due to any cause.
OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).
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From start of study treatment until death
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Progression-free Survival (PFS)
Periodo de tiempo: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
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Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause.
PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
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Percent Chance of Patient Survival
Periodo de tiempo: From start of study treatment until death
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Probability of survival 1 year and 2 years after the first dose of study treatment
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From start of study treatment until death
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Observed Plasma Trough Concentrations of Sunitinib
Periodo de tiempo: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) (Cmin) concentrations of sunitinib
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed Plasma Trough Concentrations of Sunitinib Metabolite
Periodo de tiempo: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Periodo de tiempo: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib
Periodo de tiempo: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib.
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Periodo de tiempo: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662).
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Periodo de tiempo: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662).
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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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.
Publicaciones Generales
- de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
- Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
- Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
- Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24. doi: 10.1001/jama.295.21.2516.
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 febrero de 2004
Finalización primaria (Actual)
1 de septiembre de 2008
Finalización del estudio (Actual)
1 de septiembre de 2008
Fechas de registro del estudio
Enviado por primera vez
13 de febrero de 2004
Primero enviado que cumplió con los criterios de control de calidad
17 de febrero de 2004
Publicado por primera vez (Estimar)
18 de febrero de 2004
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de octubre de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
8 de octubre de 2010
Última verificación
1 de octubre de 2010
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias Urológicas
- Neoplasias urogenitales
- Neoplasias por sitio
- Enfermedades Renales
- Enfermedades urológicas
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Renales
- Carcinoma De Célula Renal
- Carcinoma
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Inhibidores de la proteína quinasa
- Sunitinib
Otros números de identificación del estudio
- A6181006
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. .