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ES2566973T3 - Uso de SNS-595 para tratar leucemia - Google Patents

Uso de SNS-595 para tratar leucemia Download PDF

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Publication number
ES2566973T3
ES2566973T3 ES10177951.0T ES10177951T ES2566973T3 ES 2566973 T3 ES2566973 T3 ES 2566973T3 ES 10177951 T ES10177951 T ES 10177951T ES 2566973 T3 ES2566973 T3 ES 2566973T3
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ES
Spain
Prior art keywords
sns
treat leukemia
obs
patient
compound
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
ES10177951.0T
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English (en)
Other versions
ES2566973T9 (es
Inventor
Daniel C. Adelman
Jeffrey A. Silverman
Higaki Masaru
Nakao Satoshi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sumitomo Pharma Co Ltd
Viracta Therapeutics Inc
Original Assignee
Sumitomo Dainippon Pharma Co Ltd
Sunesis Pharmaceuticals Inc
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Publication date
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Publication of ES2566973T3 publication Critical patent/ES2566973T3/es
Publication of ES2566973T9 publication Critical patent/ES2566973T9/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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Abstract

Un compuesto que es ácido (+)-1,4-dihidro-7-[(3S,4S)-3-metoxi-4-(metilamino)-1-pirrolidinil]-4-oxo-1-(2-tiazolil)- 1,8-naftiridina-3-carboxílico para uso en un método de tratamiento de leucemia en un paciente, en donde el método comprende administrar el compuesto al paciente en una dosis semanal de 60 mg/m2 - 150 mg/m2.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
Composiciones ácidas (< pH 4) proporcionaron el equilibrio apropiado de mayor solubilidad del SNS-595 y propiedades farmacéuticas deseables (por ejemplo, mayor comodidad para el paciente causándole menos irritación en el sitio de administración). Un ejemplo ilustrativo de una composición adecuada comprende: 10 mg de SNS-595 por mL de solución acuosa de sorbitol al 4,5% ajustado a pH 2,5 con ácido metanosulfónico. Un protocolo para preparar dicha
5 solución incluye lo siguiente para preparar una presentación de 100 mg/10 mL: 100 mg de SNS-595 y 450 mg de Dsorbitol se añaden a agua destilada; el volumen se lleva hasta un volumen 10 mL; y el pH de la solución resultante se ajusta a 2,5 con ácido metanosulfónico. La composición resultante también es adecuada para liofilización. La forma liofilizada se reconstituye luego con agua estéril hasta la concentración apropiada antes de su uso.
Ejemplo 2
10 Farmacocinética de SNS-595 en pacientes con cáncer
SNS-595 se administró a pacientes incluidos en hasta seis ciclos. Se define un ciclo como un periodo de tres semanas, administrando SNS-595 el primer día de cada ciclo (día 0), seguido por al menos 21 días de observación. SNS595 se administró a cohortes de al menos 3 pacientes y el escalamiento de la dosis se realizó por cohortes consecutivos. Las dosis de SNS-595 fueron lineales con AUC∞ y sus propiedades farmacocinéticas fueron notablemente
15 constantes entre pacientes de la misma cohorte. La Figura 1 representa las concentraciones en el plasma de SNS595 con relación al tiempo entre los diversos cohortes de pacientes y la Tabla 1 muestra los parámetros farmacocinéticos derivados de ellas.
Tabla 1
Dosis, mg/m2
HL horas CO ng/mL Cmax. ng/mL Última AUC h-1ng/mL AUC INF_ obs h-1ng/mL CL_obs mL/min/ kg Vz_obs L/kg Vss_ obs L/kg MRTINF_obs h
3
16,27 152,25 138,80 750,08 1139,55 1,14 1,55 1,44 21,96
S.D
4,871 82,282 80,568 87,622 263 0,318 0,297 0,277 6,836
6
20,69 379,69 347,00 2400,00 2890,29 0,71 1,98 1,24 29,05
S.D
0,327 243,598 214,96 170,556 245,64 0,153 0,295 0,218 1,15
12
17,81 2888,60 2246,67 5395,53 6329,15 0,76 1,17 1,07 23,67
S.D
3,896 1302,71 1065,145 292,281 181,804 0,126 0,258 0,184 5,021
24
16,14 2884,702 2703,33 11133,03 12655,32 0,83 1,15 1,06 21,65
S.D
2,601 189,877 2573,02 488,453 851,458 0,108 0,124 0,165 5,261
48
21,32 1964,52 2868,00 21098,53 27347,36 0,99 1,57 1,46 28,90
S.D
6,32 189,877 2379,899 9405,346 14372,787 0,618 0,567 0,47 8,91
60
17,63 4797,47 4537,59 28112,17 33616,18 0,83 1,20 1,08 23,71
S.D
4,15 1947,89 1947,89 9127,12 13081,44 0,352 0,37 0,218 6,93
7

Claims (1)

  1. imagen1
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