ES2543383T3 - Tratamiento de tumores de mama con un derivado de rapamicina en combinación con exemestano - Google Patents

Tratamiento de tumores de mama con un derivado de rapamicina en combinación con exemestano Download PDF

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Publication number
ES2543383T3
ES2543383T3 ES10174983.6T ES10174983T ES2543383T3 ES 2543383 T3 ES2543383 T3 ES 2543383T3 ES 10174983 T ES10174983 T ES 10174983T ES 2543383 T3 ES2543383 T3 ES 2543383T3
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Prior art keywords
combination
administration
treatment
exemestane
rapamycin
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ES10174983.6T
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English (en)
Inventor
Heidi Lane
Terence O'reilly
Jeanette Marjorie Wood
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Novartis AG
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Novartis AG
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Priority claimed from GB0104072A external-priority patent/GB0104072D0/en
Priority claimed from GB0124957A external-priority patent/GB0124957D0/en
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    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
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    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D491/00—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof

Abstract

40-O-(2-hidroxietil)-rapamicina en combinación con exemestano para su uso en el tratamiento de tumores positivos a receptores hormonales, en donde el tumor positivo a receptores hormonales es un tumor mamario.

Description

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E10174983
22-07-2015
Con las expresiones "coadministración" o "administración combinada" o similares, como se utilizan en el presente documento se pretende abarcar la administración de los agentes terapéuticos seleccionados a un solo paciente y se pretende incluir regímenes de tratamiento en los que los agentes no necesariamente se administran por la misma vía de administración o al mismo tiempo.
Es un objetivo de esta invención proporcionar una composición farmacéutica que comprenda una cantidad, que sea conjuntamente terapéuticamente eficaz contra una enfermedad proliferativa maligna, que comprenda una combinación de la invención. En esta composición, el primer agente a) y el coagente (b) se pueden administrar juntos, uno o después del otro, o por separado en una forma de dosificación unitaria combinada o en dos formas de dosificación unitaria separadas. La forma de dosificación unitaria también puede ser una combinación fija.
Las composiciones farmacéuticas para la administración separada del primer agente a) y el coagente b) y para la administración en una combinación fija, es decir, una sola composición galénica que comprende al menos dos componentes de combinación a) y b), de acuerdo con la invención, se pueden preparar de una manera conocida por sí misma, y son aquellas adecuadas para administración enteral, tal como oral o rectal, y parenteral a mamíferos (animales de sangre caliente), incluyendo seres humanos, comprendiendo una cantidad terapéuticamente eficaz de al menos un componente de combinación farmacológicamente activo solo, por ejemplo como se ha indicado anteriormente, o en combinación con uno o más vehículos o diluyentes farmacéuticamente aceptables, especialmente adecuados para la aplicación enteral o parenteral.
Las composiciones farmacéuticas adecuadas contienen, por ejemplo, de aproximadamente 0,1 % a aproximadamente 99,9 %, preferentemente de aproximadamente 1 % a aproximadamente 60 % de los ingredientes activos. Las preparaciones farmacéuticas para la terapia de combinación para administración enteral o parenteral son, por ejemplo, aquellas que están en formas de dosificación unitaria, tales como comprimidos recubiertos con azúcar, comprimidos, cápsulas o supositorios, o ampollas. Salvo que se indique lo contrario, estas se preparan de una manera conocida por sí misma, por ejemplo, por medio de procesos convencionales de mezcla, granulación, recubrimiento con azúcar, disolución o Iiofilización. Se apreciará que el contenido unitario de un componente de combinación contenido en una dosis individual de cada forma de dosificación no necesita en sí mismo constituir una cantidad eficaz, debido a que se puede alcanzar la cantidad eficaz necesaria mediante la administración de una pluralidad de unidades de dosificación.
En particular, se puede administrar una cantidad terapéuticamente eficaz de cada uno de los componentes de combinación de la combinación de la invención de una manera simultánea o secuencial y en cualquier orden, y los componentes se pueden administrar por separado o como una combinación fija. Por ejemplo, el método de ralentización de la progresión o tratamiento de una enfermedad proliferativa maligna de acuerdo con la invención, puede comprender: (i) la administración del primer agente a) en una forma libre o de sal farmacéuticamente aceptable, y (ii) la administración de un coagente b) en una forma libre o de sal farmacéuticamente aceptable, de una manera simultánea o secuencial en cualquier orden, en cantidades conjuntamente eficaces terapéuticamente, preferentemente en cantidades sinérgicamente eficaces, por ejemplo en dosificaciones diarias o intermitentes correspondientes a las cantidades descritas en el presente documento. Los componentes de combinación individuales de la combinación de la invención se pueden administrar por separado en diferentes tiempos durante el curso de la terapia, o de una manera concurrente en formas de combinación divididas o individuales. Además, el término "administrar" también abarca el uso de un profármaco de un componente de combinación que se convierta ín vivo en el componente de combinación como tal. Por consiguiente, se debe entender que la presente invención abarca todos estos regímenes de tratamiento simultáneo o alternado y que el término "administrar" debe interpretarse de conformidad con lo mismo.
La dosificación efectiva de cada uno de los componentes de combinación empleados en la combinación de la invención puede variar dependiendo del compuesto o composición farmacéutica particular empleada, del modo de administración, de la afección que se esté tratando, de la gravedad de la afección que se esté tratando. Por consiguiente, el régimen de dosificación de la combinación de la invención se selecciona de acuerdo con diversos factores, incluyendo la vía de administración, y la función renal y hepática del paciente. Un médico, clínico, o veterinario de experiencia ordinaria puede determinar y prescribir fácilmente la cantidad eficaz de los ingredientes activos individuales requerida para prevenir, contrarrestar o detener la progresión de la afección. La precisión óptima para alcanzar la concentración de los ingredientes activos dentro del intervalo que produzca eficacia sin toxicidad requiere de un régimen basado en la cinética de la disponibilidad de los ingredientes activos en los sitios objetivo.
Las dosificaciones diarias para el primer agente a) por supuesto, variarán dependiendo de diversos factores, por ejemplo del compuesto seleccionado, de la afección particular que se vaya a tratar y del efecto deseado. Sin embargo, en general se logran resultados satisfactorios con la administración del Compuesto A a índices de dosificación diaria del orden de aproximadamente 0,1 a 25 miligramos como una sola dosis o en dosis divididas. El Compuesto A se puede administrar mediante por cualquier vía convencional, en particular por vía enteral, por ejemplo por vía oral, por ejemplo en forma de comprimidos, cápsulas, soluciones para beber, o por vía parenteral, por ejemplo en forma de soluciones o suspensiones inyectables. Las formas de dosificación unitaria adecuadas para administración oral comprenden de aproximadamente 0,05 a 10 miligramos de ingrediente activo, el Compuesto A, junto con uno o más diluyentes o vehículos farmacéuticamente aceptables para el mismo.
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Claims (1)

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ES10174983.6T 2001-02-19 2002-02-18 Tratamiento de tumores de mama con un derivado de rapamicina en combinación con exemestano Expired - Lifetime ES2543383T3 (es)

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ES16186041T Expired - Lifetime ES2705016T3 (es) 2001-02-19 2002-02-18 Derivado de rapamicina para el tratamiento de cáncer de pulmón
ES18155722T Expired - Lifetime ES2921798T3 (es) 2001-02-19 2002-02-18 Derivado de rapamicina para el tratamiento de tumores sólidos
ES14164565.5T Expired - Lifetime ES2629317T3 (es) 2001-02-19 2002-02-18 Tratamiento de tumores cerebrales sólidos con un derivado de rapamicina
ES14164259.5T Expired - Lifetime ES2640787T3 (es) 2001-02-19 2002-02-18 Combinación de un derivado de rapamicina y letrozol para tratar el cáncer de mama
ES18155644T Expired - Lifetime ES2728739T3 (es) 2001-02-19 2002-02-18 Derivado de rapamicina para el tratamiento de un tumor sólido asociado con angiogénesis desregulada
ES10174985.1T Expired - Lifetime ES2600304T3 (es) 2001-02-19 2002-02-18 Tratamiento de tumores sólidos de riñón con un derivado de rapamicina
ES10174983.6T Expired - Lifetime ES2543383T3 (es) 2001-02-19 2002-02-18 Tratamiento de tumores de mama con un derivado de rapamicina en combinación con exemestano
ES18155724T Expired - Lifetime ES2744377T3 (es) 2001-02-19 2002-02-18 Derivado de rapamicina para tratar cáncer de páncreas

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ES16186041T Expired - Lifetime ES2705016T3 (es) 2001-02-19 2002-02-18 Derivado de rapamicina para el tratamiento de cáncer de pulmón
ES18155722T Expired - Lifetime ES2921798T3 (es) 2001-02-19 2002-02-18 Derivado de rapamicina para el tratamiento de tumores sólidos
ES14164565.5T Expired - Lifetime ES2629317T3 (es) 2001-02-19 2002-02-18 Tratamiento de tumores cerebrales sólidos con un derivado de rapamicina
ES14164259.5T Expired - Lifetime ES2640787T3 (es) 2001-02-19 2002-02-18 Combinación de un derivado de rapamicina y letrozol para tratar el cáncer de mama
ES18155644T Expired - Lifetime ES2728739T3 (es) 2001-02-19 2002-02-18 Derivado de rapamicina para el tratamiento de un tumor sólido asociado con angiogénesis desregulada
ES10174985.1T Expired - Lifetime ES2600304T3 (es) 2001-02-19 2002-02-18 Tratamiento de tumores sólidos de riñón con un derivado de rapamicina

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