ES2521672T3 - Formulaciones farmacéuticas para el tratamiento del cáncer - Google Patents

Formulaciones farmacéuticas para el tratamiento del cáncer Download PDF

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Publication number
ES2521672T3
ES2521672T3 ES09008756.0T ES09008756T ES2521672T3 ES 2521672 T3 ES2521672 T3 ES 2521672T3 ES 09008756 T ES09008756 T ES 09008756T ES 2521672 T3 ES2521672 T3 ES 2521672T3
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Prior art keywords
patients
pharmaceutical formulations
cancer treatment
multiple myeloma
formula
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ES09008756.0T
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English (en)
Inventor
Jerome B. Zeldis
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Celgene Corp
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Celgene Corp
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    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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Abstract

Un compuesto de fórmula :**Fórmula** o su sal farmacéuticamente aceptable, solvato, hidrato o estereoisómero, para su uso en un método para tratar o gestionar diversos tipos o estadios del mieloma múltiple, en el que dicho método comprende además la administración de un segundo agente activo, en el que el segundo agente activo es dexametasona.

Description

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E09008756
28-10-2014
Tabla 1
Parámetros farmacocinéticos de Actimid™ en pacientes con mieloma múltiple en recaída
Parámetro
1 mg (N = 6) 2 mg (N = 2) 5 mg (N = 3)
Día 1
Cmax
ng/ml 15,03 (4,04) 24,4* (12,1) 48,56 (14,03)
tmax
h 3,3 (2,6) 2,7* (0,3) 2,3 (0,3)
AUC(0-)
ng.h/ml 152,90 (36,62) 279,18 (51,10) 593,10 (335,23)
AUC(0-t)
134,21 (27,14) 249,57 (29,26) 520,94 (267,32)
t½
h 7,3 (3,4) 6,3 (1,4) 6,5 (2,2)
CL/F
ml/min 114,75 (29,20) 121,43 (22,22) 182,31 (117,06)
Vz/f
l 69,55 (44,97) 65,31 (2,80) 87,24 (22,61)
t = 24 horas, N/A = no disponible
Tabla 2
Parámetros farmacocinéticos de Actimid™ tras recibir múltiples dosis orales (1, 2 y 5 mg/día) en pacientes con mieloma múltiple en recaída
Parámetro
1 mg (N = 6) 2 mg (N = 2) 5 mg (N = 3)
Semana 4
Cmax
ng/ml 23,20 (7,48) 30,05* (15,64) 59,07 (38,08)
tmax
h 3,6 (1,5) 2,8* (0,3) 5,0 (2,6)
AUC(0-)
ng.h/ml N/A N/A N/A
AUC(0-t)
239,31 (122,59) 269,36 (186,34) 597,24 (354,23)
t½
h 6,2* (0,6) 7,7 (2,8) 7,8 (4,0)
CL/F
ml/min 87,85 (48,48) 162,68 (112,54) 207,50 (175,41)
Vz/f
l 41,35* (8,84) 95,04 (35,39) 103,95 (27,25)
t = 24 horas, N/A = no disponible, *N = 3 pacientes
5 6.5.2 Tratamiento del mieloma múltiple en recaída (referencia)
Se realizaron dos estudios clínicos de fase 1 de la 3-(4-amino-1-oxo-1,3-dihidroisoindol-2-il)piperidin-2,6-diona (Revimid™) para identificar la dosis máxima tolerada (MTD) en pacientes con mieloma múltiple refractario o en recaída. Estos estudios también han caracterizado el perfil de seguridad de la 3-(4-amino-1-oxo-1,3-dihidroisoindol2-il)piperidin-2,6-diona cuando se administran dosis crecientes de 3-(4-amino-1-oxo-1,3-dihidroisoindol-2-il)piperidin10 2,6-diona por vía oral durante hasta 4 semanas. Los pacientes comenzaron con el tratamiento de 3-(4-amino-1-oxo1,3-dihidroisoindol-2-il)piperidin-2,6-diona a 5 mg/día con un posterior aumento hasta 10, 25 y 50 mg/dia. Los pacientes se incluyeron durante 28 días a su dosis asignada, con la opción de un tratamiento prolongado para aquellos que no mostraban avance de la enfermedad o toxicidad limitante de la dosis (DLT). Los pacientes se evaluaron para la presencia de acontecimientos adversos en cada visita y se clasificó la gravedad de estos
15 acontecimientos según los criterios de toxicidad habituales de the National Cancer Institute (NCI). Los pacientes abandonaban el estudio si mostraban DLT (toxicidad no hematológica de grado 3 o mayor, o toxicidad hematológica de grado 4).
En este estudio se incluyeron 27 pacientes. Todos los pacientes presentaban mieloma múltiple en recaída, y 18 (72%) eran refractarios a la terapia de rescate. Entre estos pacientes, 15 habían sufrido un transplante previo de
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Claims (1)

  1. imagen1
ES09008756.0T 2002-05-17 2003-05-16 Formulaciones farmacéuticas para el tratamiento del cáncer Expired - Lifetime ES2521672T3 (es)

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ES03728969T Expired - Lifetime ES2340027T3 (es) 2002-05-17 2003-05-16 Combinaciones para tratar el mieloma multiple.

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JP2015187156A (ja) 2015-10-29
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IL219732A0 (en) 2012-06-28
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IL165254A (en) 2013-03-24
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