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A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)

2 de octubre de 2009 actualizado por: Pfizer

A Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.

Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability.

Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

36

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

  • Japón
    • Chiba
      • Kashiwa, Chiba, Japón
        • Pfizer Investigational Site
    • Hokkaido
      • Sapporo, Hokkaido, Japón
        • Pfizer Investigational Site
    • Osaka
      • Suita, Osaka, Japón
        • Pfizer Investigational Site
    • Tokyo
      • Chuo-ku, Tokyo, Japón
        • Pfizer Investigational Site

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

20 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST).
  • Patients previously treated with imatinib mesylate.

Exclusion Criteria:

  • Patients who have not recovered from the acute toxic effects of previous antineoplastic therapy or treatment with imatinib mesylate.
  • Any tumor therapy for gastrointestinal stromal tumor (GIST) discontinued less than 4 weeks prior to starting study treatment. Imatinib mesylate discontinued less than 2 weeks prior to starting therapy.

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
Experimental: SU011248
25 , 50 or 75 mg/day of SU011248
Droga: Sunitinib malate (SU011248)
SU011248

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects With Dose Limiting Toxicities (DLT)
Periodo de tiempo: Cycle 1 (Baseline to Week 6)
Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1.
Cycle 1 (Baseline to Week 6)
Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1
Periodo de tiempo: Day 1 of Cycle 1

Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.

The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662).
Day 1 of Cycle 1
Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28
Periodo de tiempo: Day 28 of Cycle 1

Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.

The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662).
Day 28 of Cycle 1
Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1
Periodo de tiempo: Day 1 of Cycle 1

Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.

The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662).
Day 1 of Cycle 1
Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28
Periodo de tiempo: Day 28 of Cycle 1

Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.

The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662).
Day 28 of Cycle 1
Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1
Periodo de tiempo: Day 1 of Cycle 1

Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.

The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662).
Day 1 of Cycle 1
Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28
Periodo de tiempo: Day 28 of Cycle 1

Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.

The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662).
Day 28 of Cycle 1
SU-011248 Clearance on Cycle 1 Day 28
Periodo de tiempo: Day 28 of Cycle 1

SU-011248 Clearance in the subjects enrolled in Phase 1.

Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL).
Day 28 of Cycle 1
Accumulation Ratio (Rac) on Cycle 1 Day 28
Periodo de tiempo: Day 28 of Cycle 1

Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1.

Rac was the ratio of Day 28 to Day 1.
Day 28 of Cycle 1
Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group
Periodo de tiempo: Day 28 of Cycles 1-4
Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).
Day 28 of Cycles 1-4

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Periodo de tiempo: Day 1, 14, 28 of Cycles 1-4
Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)
Day 1, 14, 28 of Cycles 1-4
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Periodo de tiempo: Day 1, 14, 28 of Cycles 1-4
Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Day 1, 14, 28 of Cycles 1-4
Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)
Periodo de tiempo: Day 1, 14, 28 of Cycles 1-4
Plasma concentrations of potential pharmacodynamic markers; Soluble Stem Cell Factor Receptor (sKIT)
Day 1, 14, 28 of Cycles 1-4
Trough Plasma Concentration (Ctrough) of SU-011248
Periodo de tiempo: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) of SU-012262
Periodo de tiempo: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662
Periodo de tiempo: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires
Periodo de tiempo: Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4

Patient-reported outcome: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaires (version 4A).

The questionnaire consists of a 13-item subscale which covers specific fatigue questions. The subject rates the intensity of fatigue and its related symptoms on a five-point scale(0 to 4). High score is indicating low fatigue. The total score of the 13 items was evaluated.

Change from Baseline: Score at each observation minus score at baseline
Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires
Periodo de tiempo: Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4

The EQ-5D questionnaires evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale(1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index. High score is indicating high health.

Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline
Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4
Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group
Periodo de tiempo: Day 28 of Cycles 1-4
Number of subjects with Disease Controlled is defined as sum of the subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 10 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).
Day 28 of Cycles 1-4
Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group
Periodo de tiempo: Day 28 of Cycles 1-4
Number of subjects with Objective Response is defined as sum of the subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Day 28 of Cycles 1-4
Time To Tumor Progression (TTP)
Periodo de tiempo: From the first dose to Progressive Disease
Time To tumor Progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD).
From the first dose to Progressive Disease
Progression-Free Survival (PFS)
Periodo de tiempo: From the first dose to Progressive Disease or Death
Progression-Free Survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD) or death.
From the first dose to Progressive Disease or Death
Time To Failure (TTF)
Periodo de tiempo: From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.
Time To Failure (TTF) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer.
From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.
Overall Survival Time
Periodo de tiempo: From the first dose to death

Overall Survival Time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, Overall Survival Time was censored on the last date when the patient was known to be alive.

Survival was surveyed once a year from the registration day of the first subject, for all the subjects who received the study drug at least once.
From the first dose to death

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

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.

Enlaces Útiles

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 enero de 2005

Finalización primaria (Actual)

1 de agosto de 2008

Finalización del estudio (Actual)

1 de agosto de 2008

Fechas de registro del estudio

Enviado por primera vez

4 de abril de 2007

Primero enviado que cumplió con los criterios de control de calidad

4 de abril de 2007

Publicado por primera vez (Estimar)

6 de abril de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

13 de noviembre de 2009

Última actualización enviada que cumplió con los criterios de control de calidad

2 de octubre de 2009

Última verificación

1 de octubre de 2009

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A6181045
  • JapicCTI-070386

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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