- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00113529
Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma
25 de agosto de 2011 actualizado por: Pfizer
A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1).
To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
42
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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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- 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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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111-2497
- 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:
- Histologically confirmed renal cell carcinoma with metastases
- Evidence of unidimensionally measurable disease
- Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC
Exclusion Criteria:
- RCC without any clear (conventional) cell component
- History of or known brain metastases
- Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry
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: Sunitinib + Gefitinib
Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib |
Until disease 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 |
---|---|---|
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Periodo de tiempo: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST.
A CR was defined as the disappearance of all target lesions.
A PR was defined as a ≥ 30% 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 treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time to Tumor Response (TTR)
Periodo de tiempo: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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TTR was defined as the time from date of the first dose of study medication to first documentation of objective tumor response (CR or PR).
For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response.
If lesion assessment data included more than 1 date, the first date was used.
TTR was calculated as (first event date minus first dose date +1)/7.
TTR was calculated based on the subgroup of subjects with a baseline disease assessment, who had the correct histological cancer type, and had a confirmed objective tumor response.
Kaplan-Meier method was used.
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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Duration of Response (DR)
Periodo de tiempo: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
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DR was defined as the time from start of the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first.
If tumor progression data included more than 1 date, the first date was used.
DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1)/7.
DR was calculated for the subgroup of subjects with an objective tumor response (CR or PR).
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
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Time to Tumor Progression (TTP)
Periodo de tiempo: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression.
If tumor progression data included more than 1 date, the first date was used.
TTP (in weeks) was calculated as (first event date minus first dose date +1)/7.
Kaplan-Meier method was used.
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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Overall Survival (OS)
Periodo de tiempo: From start of study treatment until death
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OS was defined as the time from date of the first dose of study medication to date of death due to any cause.
OS (in weeks) is calculated as (date of death minus first dose date +1)/7.
For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive.
Subjects lacking data beyond the day of first dose had their survival times censored at 1 day.
Kaplan-Meier method was used.
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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 treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
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PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
If tumor progression data included more than 1 date, the first date was used.
PFS (in weeks) was calculated as (first event date minus first dose date +1)/7.
Kaplan-Meier method was used.
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
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Probability of Survival at One Year
Periodo de tiempo: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
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Survival rate was defined as the percentage of subjects alive at 1 year after the date of first administration of study medication.
Survival rate was estimated using the Kaplan-Meier method.
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
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VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline
Periodo de tiempo: Baseline (Cycle 1, Day 1)
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Concentration of VEGF at baseline.
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Baseline (Cycle 1, Day 1)
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VEGF Ratio to Baseline at Each Time Point
Periodo de tiempo: Baseline to Cycle 3, Day 28 inclusive
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VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
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Baseline to Cycle 3, Day 28 inclusive
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VEGF-C Concentration at Baseline
Periodo de tiempo: Baseline (Cycle 1, Day 1)
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Concentration of VEGF-C at baseline.
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Baseline (Cycle 1, Day 1)
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VEGF-C Ratio to Baseline at Each Time Point
Periodo de tiempo: Baseline to Cycle 3, Day 28 inclusive
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VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).
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Baseline to Cycle 3, Day 28 inclusive
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Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Periodo de tiempo: Baseline (Cycle 1, Day 1)
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Concentration of sVEGFR2 at baseline.
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Baseline (Cycle 1, Day 1)
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sVEGFR2 Ratio to Baseline at Each Time Point
Periodo de tiempo: Baseline to Cycle 3, Day 28 inclusive
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sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
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Baseline to Cycle 3, Day 28 inclusive
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Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline
Periodo de tiempo: Baseline (Cycle 1, Day 1)
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Concentration of sVEGFR3 at baseline.
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Baseline (Cycle 1, Day 1)
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sVEGFR3 Ratio to Baseline at Each Time Point
Periodo de tiempo: Baseline to Cycle 3, Day 28 inclusive
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sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline).
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Baseline to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGF level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGF level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGFC level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFC level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGFR2 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR2 level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGFR3 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR3 level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGF level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGF level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGFC level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFC level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGFR2 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR2 level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGFR3 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR3 level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGF level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGF level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGFC level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFC level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGFR2 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR2 level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median
Periodo de tiempo: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change = median VEGFR3 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR3 level at Baseline.
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Trough Plasma Concentrations (Ctrough) of Sunitinib
Periodo de tiempo: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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Ctrough of SU-012662 (Sunitinib's Metabolite)
Periodo de tiempo: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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Ctrough of Gefitinib
Periodo de tiempo: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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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
1 de octubre de 2004
Finalización primaria (Actual)
1 de septiembre de 2007
Finalización del estudio (Actual)
1 de octubre de 2008
Fechas de registro del estudio
Enviado por primera vez
8 de junio de 2005
Primero enviado que cumplió con los criterios de control de calidad
8 de junio de 2005
Publicado por primera vez (Estimar)
9 de junio de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
29 de agosto de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
25 de agosto de 2011
Última verificación
1 de agosto de 2011
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
- Gefitinib
Otros números de identificación del estudio
- A6181038
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 Carcinoma De Célula Renal
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University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and Kidney... y otros colaboradoresReclutamientoEnfermedades Renales Crónicas | Fallo renal agudo | Lesión renal aguda | Insuficiencia Renal Aguda | Insuficiencia renal cronica | Insuficiencia Renal, Aguda | Insuficiencia Renal Aguda | Insuficiencia Renal Aguda | Insuficiencia Renal Aguda | Insuficiencia renal aguda | Insuficiencia Renal Crónica | Enfermedades... y otras condicionesEstados Unidos
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3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillTerminadoEnfermedades Renales Crónicas | Enfermedad Renal Crónica Etapa 5 | Enfermedad Renal Crónica etapa 4 | Enfermedad renal pediátrica | Enfermedad Renal Crónica etapa 3 | Enfermedad Renal Crónica Etapa V | Enfermedad renal crónica, estadio IV (grave) | Enfermedad Renal Crónica Etapa 2 | Enfermedad Renal...Estados Unidos
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University Hospital, BordeauxMinistry of Health, FranceTerminadoTrasplante Renal | Enfermedad renal crónica en etapa terminal | Insuficiencia Renal Aguda SeveraFrancia
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Wake Forest University Health SciencesStanford UniversityTerminadoTrasplante Renal | Rechazo Renal Agudo | Rechazo Renal Crónico | Rechazo de Trasplante Renal | Sistema Renina-AngiotensinaEstados Unidos
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Faculdade de Ciências Médicas da Santa Casa de...TerminadoEnfermedad Renal Crónica | Diálisis renalBrasil
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Outset MedicalTerminadoLesión renal aguda | Enfermedad renal en etapa terminal (ESRD) | Enfermedad renal en etapa terminal en diálisisEstados Unidos
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Novartis PharmaceuticalsTerminadoHemodiálisis | Terapia de reemplazo renal | Enfermedad renal en etapa terminal (ESRD) | Trasplante Renal | Enfermedad renal crónica (ERC)Alemania, Estados Unidos, Bélgica, Italia, España, Croacia, Taiwán, Australia, Austria, Grecia, Corea, república de, Líbano, Chequia, Israel, Países Bajos, Eslovenia, Suiza, Tailandia, Noruega, Pavo, Suecia, Argentina, Brasil, Japón, Serbia, Federación Rusa y más
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ArdelyxAstraZenecaTerminadoEnfermedad renal en etapa terminal | ESRD | Enfermedad Renal Crónica Etapa 5Estados Unidos
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Vanessa Stadlbauer-Koellner, MDAustrian Science Fund (FWF)TerminadoFallo renal agudo | Insuficiencia renal cronicaAustria
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Angiodynamics, Inc.TerminadoEnfermedad Renal Crónica | Lesión renal aguda | Fallo renal agudo | Insuficiencia renal crónica inducida por contrasteEstados Unidos
Ensayos clínicos sobre Gefitinib + Sunitinib
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Sun Yat-sen UniversityDesconocidoCánceres gastrointestinalesPorcelana
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Sun Yat-sen UniversityDesconocido
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Qilu Pharmaceutical Co., Ltd.DesconocidoCáncer de pulmón de células no pequeñasPorcelana
-
Jiangsu Famous Medical Technology Co., Ltd.DesconocidoCáncer de pulmón de células no pequeñas
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AstraZenecaTerminadoNeoplasias De Células EscamosasEstados Unidos, República Checa, Polonia, Alemania, Bélgica, Taiwán, India, Serbia
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Kunming Medical UniversityTerminadoCáncer de pulmón de células no pequeñasPorcelana
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Anhui Medical UniversityDesconocidoAutoeficacia | Toxicidad de drogasPorcelana
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NCIC Clinical Trials GroupTerminadoCancer de prostataCanadá
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University of Maryland, BaltimoreNational Cancer Institute (NCI); University of Maryland Greenebaum Cancer CenterTerminadoCancer de RIÑONEstados Unidos
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Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminadoCáncer de ovarios | Cáncer primario de cavidad peritonealEstados Unidos, Canadá, Reino Unido, Australia