ES2566973T3 - Uso de SNS-595 para tratar leucemia - Google Patents
Uso de SNS-595 para tratar leucemia Download PDFInfo
- 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
- Authority
- ES
- Spain
- Prior art keywords
- sns
- compound
- treat leukemia
- obs
- patient
- 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.)
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- XZAFZXJXZHRNAQ-STQMWFEESA-N vosaroxin Chemical compound C1[C@H](OC)[C@@H](NC)CN1C1=CC=C2C(=O)C(C(O)=O)=CN(C=3SC=CN=3)C2=N1 XZAFZXJXZHRNAQ-STQMWFEESA-N 0.000 title abstract description 9
- 208000032839 leukemia Diseases 0.000 title 1
- 206010028980 Neoplasm Diseases 0.000 abstract description 2
- 150000001875 compounds Chemical class 0.000 abstract 3
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 description 4
- 239000000203 mixture Substances 0.000 description 3
- 229940098779 methanesulfonic acid Drugs 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 230000036470 plasma concentration Effects 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 239000008223 sterile water Substances 0.000 description 1
Classifications
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- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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- Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
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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
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)
-
imagen1
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US55357804P | 2004-03-15 | 2004-03-15 | |
US553578P | 2004-03-15 |
Publications (2)
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ES2566973T3 true ES2566973T3 (es) | 2016-04-18 |
ES2566973T9 ES2566973T9 (es) | 2017-01-03 |
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Application Number | Title | Priority Date | Filing Date |
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ES05731600T Active ES2358267T3 (es) | 2004-03-15 | 2005-03-14 | Composición farmacéutica que comprende sns-595 y sus usos. |
ES05732554T Active ES2334802T3 (es) | 2004-03-15 | 2005-03-14 | Sns-595 y metodos de uso del mismo. |
ES10177951.0T Active ES2566973T3 (es) | 2004-03-15 | 2005-03-14 | Uso de SNS-595 para tratar leucemia |
Family Applications Before (2)
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ES05731600T Active ES2358267T3 (es) | 2004-03-15 | 2005-03-14 | Composición farmacéutica que comprende sns-595 y sus usos. |
ES05732554T Active ES2334802T3 (es) | 2004-03-15 | 2005-03-14 | Sns-595 y metodos de uso del mismo. |
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US (12) | US7968565B2 (es) |
EP (4) | EP1729770B1 (es) |
JP (9) | JP5096913B2 (es) |
KR (1) | KR101169825B1 (es) |
CN (5) | CN103251589B (es) |
AT (2) | ATE493982T1 (es) |
AU (3) | AU2005222622B2 (es) |
BR (1) | BRPI0508700A (es) |
CA (3) | CA2559650C (es) |
CY (2) | CY1109741T1 (es) |
DE (2) | DE602005025738D1 (es) |
DK (3) | DK1725233T3 (es) |
ES (3) | ES2358267T3 (es) |
HK (1) | HK1097196A1 (es) |
HU (1) | HUE027266T2 (es) |
IL (2) | IL177946A (es) |
MX (2) | MX349188B (es) |
NO (3) | NO338058B1 (es) |
NZ (2) | NZ549557A (es) |
PL (3) | PL1729770T3 (es) |
PT (2) | PT1729770E (es) |
SI (2) | SI1725233T1 (es) |
WO (2) | WO2005089756A1 (es) |
ZA (1) | ZA200607248B (es) |
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2007
- 2007-05-07 HK HK07104836.3A patent/HK1097196A1/xx not_active IP Right Cessation
-
2010
- 2010-01-21 CY CY20101100063T patent/CY1109741T1/el unknown
-
2011
- 2011-02-03 CY CY20111100114T patent/CY1111263T1/el unknown
- 2011-03-22 AU AU2011201277A patent/AU2011201277B2/en not_active Ceased
- 2011-04-27 US US13/095,111 patent/US20110263524A1/en not_active Abandoned
- 2011-06-13 US US13/159,258 patent/US8669270B2/en not_active Expired - Fee Related
- 2011-06-17 JP JP2011135675A patent/JP2011225590A/ja active Pending
-
2012
- 2012-02-23 JP JP2012036919A patent/JP2012140442A/ja active Pending
-
2013
- 2013-03-11 US US13/794,583 patent/US8822493B2/en not_active Expired - Fee Related
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2014
- 2014-02-03 US US14/171,673 patent/US20140378505A1/en not_active Abandoned
- 2014-04-25 JP JP2014091125A patent/JP5856644B2/ja not_active Expired - Fee Related
- 2014-08-18 US US14/462,439 patent/US9980949B2/en not_active Expired - Fee Related
- 2014-09-05 JP JP2014180862A patent/JP6261477B2/ja not_active Expired - Fee Related
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2015
- 2015-04-17 NO NO20150466A patent/NO339613B1/no not_active IP Right Cessation
- 2015-07-14 JP JP2015140309A patent/JP6352863B2/ja not_active Expired - Fee Related
-
2016
- 2016-01-14 US US14/996,025 patent/US9757363B2/en not_active Expired - Fee Related
- 2016-09-26 IL IL248049A patent/IL248049A0/en unknown
- 2016-11-24 NO NO20161867A patent/NO20161867A1/no not_active Application Discontinuation
- 2016-12-21 JP JP2016248041A patent/JP2017095471A/ja active Pending
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2018
- 2018-03-05 JP JP2018038834A patent/JP2018119977A/ja active Pending
- 2018-04-27 US US15/965,741 patent/US20180316309A1/en not_active Abandoned
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