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NCT01059643

Un estudio en cáncer de ovario, cáncer de pulmón no microcítico, cáncer de próstata, cáncer colorrectal, cáncer gastroesofágico y carcinoma de células escamosas de cabeza y cuello.

Archived Fase 2

Descripción

El objetivo del estudio es determinar la tasa de respuesta en pacientes con cáncer de ovario, cáncer de pulmón no microcítico, cáncer de próstata, cáncer colorrectal, cáncer gastroesofágico y cáncer de cabeza y cuello a los que se les administra LY2523355.

Criterios de Elegibilidad

Criterios de inclusión:

  • Diagnóstico de cáncer de ovario, cáncer de pulmón no microcítico, cáncer de próstata, cáncer colorrectal, cáncer gastroesofágico (adenocarcinoma del cáncer de esófago, estómago o unión gastroesofágica) o cáncer de células escamosas de cabeza y cuello.
  • Presencia de enfermedad medible definida por los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) 1.1 (excepto en los participantes con cáncer de próstata).
  • Tener un índice de rendimiento del Grupo de Oncología Cooperativa del Este (ECOG) de 0 a 1.
  • Estar dispuesto a seguir los procedimientos del estudio durante toda su duración.
  • Estar dispuesto a utilizar un método anticonceptivo aprobado durante el tratamiento y durante 3 meses después de la interrupción del tratamiento del estudio.

Criterios de exclusión:

  • Presentar una enfermedad médica preexistente grave que impida la participación en el estudio.
  • Estar embarazada o en período de lactancia.
  • Haber recibido tratamiento dentro de los 28 días previos a la primera dosis de LY2523355 con un fármaco que no haya recibido la aprobación regulatoria para ninguna indicación.
  • Presentar metástasis sintomáticas, no tratadas o no controladas en el sistema nervioso central (SNC).
  • Tener un segundo cáncer primario activo o antecedentes de un segundo cáncer que requiera terapia citotóxica.
  • Tener un intervalo QTc mayor de 470 milisegundos (mseg) o un retraso en la conducción intraventricular (RCDI) con un QRS mayor de 120 mseg en el electrocardiograma (ECG) de cribado.
  • Tener una infección fúngica, bacteriana y/o viral activa conocida, incluida la infección activa por el virus de la inmunodeficiencia humana (VIH) o la hepatitis viral (A, B, C).
  • Los participantes con neumonía, evidencia de neumonitis obstructiva, otras infecciones respiratorias o infecciones de otras fuentes deben ser excluidos.

Información del Ensayo

NCT01059643
Archived
Fase 2
103 participantes
Abr 2011

Ubicaciones18

United States (18)
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Jonesboro, Arkansas, 72401
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Jacksonville, Florida, 32256
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Macon, Georgia, 31201
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Marietta, Georgia, 30060
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Valdosta, Georgia, 31602
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Post Falls, Idaho, 83854
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Westwood, Kansas, 66205
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Wichita, Kansas, 67214
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Baton Rouge, Louisiana, 70809
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Bethesda, Maryland, 20817
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Billings, Montana, 59102
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Columbus, Ohio, 43219
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Oklahoma City, Oklahoma, 73120
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Charleston, South Carolina, 29425
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Germantown, Tennessee, 38138
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Memphis, Tennessee, 38120
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Corpus Christi, Texas, 78404
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Morgantown, West Virginia, 26506