ES2566973T9 - Uso de SNS-595 para tratar leucemia - Google Patents

Uso de SNS-595 para tratar leucemia Download PDF

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Publication number
ES2566973T9
ES2566973T9 ES10177951.0T ES10177951T ES2566973T9 ES 2566973 T9 ES2566973 T9 ES 2566973T9 ES 10177951 T ES10177951 T ES 10177951T ES 2566973 T9 ES2566973 T9 ES 2566973T9
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Spain
Prior art keywords
sns
compound
treat leukemia
obs
patient
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ES10177951.0T
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ES2566973T3 (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 of ES2566973T9 publication Critical patent/ES2566973T9/es
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    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
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Description

imagen1
imagen2
imagen3
imagen4
imagen5
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.
5 Ejemplo 2
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 consecu
10 tivos. Las dosis de SNS-595 fueron lineales con AUC∞ y sus propiedades farmacocinéticas fueron notablemente 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

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