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Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

20 de julio de 2011 actualizado por: Pfizer

A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer

The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

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

  • Bélgica
      • Ottignies, Bélgica, 1340
        • Pfizer Investigational Site
      • Wilrijk, Bélgica, 2610
        • Pfizer Investigational Site
  • Canadá
    • Ontario
      • Toronto, Ontario, Canadá, M4N 3M5
        • Pfizer Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canadá, J4V 2H1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canadá, H3G 1A4
        • Pfizer Investigational Site
  • España
      • Barcelona, España, 08003
        • Pfizer Investigational Site
      • Madrid, España, 28040
        • Pfizer Investigational Site
      • Valencia, España, 46010
        • Pfizer Investigational Site
  • Estados Unidos
    • Alabama
      • Montgomery, Alabama, Estados Unidos, 36106
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, Estados Unidos, 19713
        • Pfizer Investigational Site
      • Newark, Delaware, Estados Unidos, 19718-6001
        • Pfizer Investigational Site
      • Wilmington, Delaware, Estados Unidos, 19899
        • Pfizer Investigational Site
    • Florida
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • Pfizer Investigational Site
    • Illinois
      • Harvey, Illinois, Estados Unidos, 60426
        • Pfizer Investigational Site
      • Tinley Park, Illinois, Estados Unidos, 60477
        • Pfizer Investigational Site
    • Indiana
      • Munster, Indiana, Estados Unidos, 46321
        • Pfizer Investigational Site
    • Louisiana
      • Lafayette, Louisiana, Estados Unidos, 70503
        • Pfizer Investigational Site
      • New Iberia, Louisiana, Estados Unidos, 70563
        • Pfizer Investigational Site
    • Mississippi
      • Corinth, Mississippi, Estados Unidos, 38834
        • Pfizer Investigational Site
      • Southaven, Mississippi, Estados Unidos, 38671
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89135
        • Pfizer Investigational Site
    • New York
      • New York, New York, Estados Unidos, 10021
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38104
        • Pfizer Investigational Site
      • Memphis, Tennessee, Estados Unidos, 38120
        • Pfizer Investigational Site
  • Francia
      • Besancon, Francia, 25030
        • Pfizer Investigational Site
      • Lyon, Francia, 69373
        • Pfizer Investigational Site
      • Saint Cloud, Francia, 92210
        • 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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
  • HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
  • Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.

Exclusion Criteria:

  • Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
  • Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
  • Prior treatment on a SU11248 clinical trial.
  • Uncontrolled brain metastases.

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: A
Droga: SU011248/Trastuzumab
SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Overall Confirmed Objective Disease Response
Periodo de tiempo: From start of treatment through 18 months
Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-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 associated to a non-progressive disease response for the non target lesions.
From start of treatment through 18 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Duration of Response (DR)
Periodo de tiempo: From start of treatment through 18 months
Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. 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) divided by 7.
From start of treatment through 18 months
Percentage of Participants With Clinical Benefit
Periodo de tiempo: From start of treatment through 18 months
Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.
From start of treatment through 18 months
Progression Free Survival (PFS)
Periodo de tiempo: From start of treatment through 18 months
Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7.
From start of treatment through 18 months
Time to Progression (TTP)
Periodo de tiempo: From start of treatment through 18 months
Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7.
From start of treatment through 18 months
Overall Survival (OS)
Periodo de tiempo: From start of study treatment until death or 2 years from first study treatment
Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33.
From start of study treatment until death or 2 years from first study treatment
Probability of Survival at One Year
Periodo de tiempo: From start of study treatment until death or 2 years from first study treatment
One- year survival probability was estimated using the Kaplan-Meier method.
From start of study treatment until death or 2 years from first study treatment
EORTC QLQ-C30
Periodo de tiempo: From start of treatment through 18 months
EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.
From start of treatment through 18 months
EORTC QLQ (BR23)
Periodo de tiempo: From start of treatment through 18 months
BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
From start of treatment through 18 months
Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib
Periodo de tiempo: Predose on Day 1 of Cycle 3 and 5
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Predose on Day 1 of Cycle 3 and 5
Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
Periodo de tiempo: Predose on Day 1 of Cycle 3 and 5
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Predose on Day 1 of Cycle 3 and 5
Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Periodo de tiempo: Predose on Day 1 of Cycle 3 and 5
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Predose on Day 1 of Cycle 3 and 5

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.

Publicaciones Generales

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 febrero de 2006

Finalización primaria (Actual)

1 de abril de 2009

Finalización del estudio (Actual)

1 de julio de 2010

Fechas de registro del estudio

Enviado por primera vez

20 de octubre de 2005

Primero enviado que cumplió con los criterios de control de calidad

20 de octubre de 2005

Publicado por primera vez (Estimar)

24 de octubre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

22 de julio de 2011

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

20 de julio de 2011

Última verificación

1 de julio de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A6181067

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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