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2. 发明申请

US20150164933A1 DOSAGE REGIMEN FOR SAPACITABINE AND SELICICLIB 有权
标题翻译：用于SAPACITABINE和SELICICLIB的剂量计
公开(公告)号：US20150164933A1
公开(公告)日：2015-06-18
申请号：US14401357
申请日：2013-05-14
申请人： Cyclacel Limited
发明人： Judy H. Chiao , David Blake , Daniella Zheleva , Susan Davis , Simon Green , Geoffrey Shapiro
IPC分类号： A61K31/7068 , A61K9/00 , A61K31/52
CPC分类号： A61K31/7068 , A61K9/0053 , A61K31/52 , A61P35/00 , A61P35/02 , A61K2300/00
摘要： A first aspect of the invention relates to a method of treating a proliferative disorder in a subject, said method comprising administering to the subject a therapeutically effective amount of (i) sapacitabine, or a metabolite thereof; and (ii) seliciclib; in accordance with a dosing regimen comprising at least one first treatment cycle and at least one second treatment cycle, wherein said i first treatment cycle comprises: (a) administering a therapeutically effective amount of sapacitabine, or a metabolite thereof, for 3 to 5 consecutive days for 2 weeks, starting on day d, where d is the first day of treatment with sapacitabine, or the metabolite thereof, in said first treatment cycle; and (b) optionally administering a therapeutically effective amount of seliciclib for 3 to 5 consecutive days for 2 weeks, starting on day (d−1) relative to the administration of sapacitabine or the metabolite thereof, in said first treatment cycle; followed by a rest period of at least 2 weeks, or until treatment-related toxicities are resolved, whichever is longer; and wherein said second treatment cycle comprises: (a) administering a therapeutically effective amount of sapacitabine, or a metabolite thereof, for 3 to 5 consecutive days for 2 weeks, starting on day d, where d is the first day of treatment with sapacitabine, or the metabolite thereof, in said second treatment cycle; and (b) administering a therapeutically effective amount of seliciclib for 3 to 5 consecutive days for 2 weeks, starting on day (d−1) relative to the administration of sapacitabine or the metabolite thereof, in said second treatment cycle; followed by a rest period of at least 2 weeks, or until treatment-related toxicities are resolved, whichever is longer. Further aspects of the invention relate to a kit of parts, and corresponding uses.
摘要翻译：本发明的第一方面涉及治疗受试者中增殖性疾病的方法，所述方法包括给予受试者治疗有效量的（i）西他滨或其代谢物; 和（ii）seliciclib; 根据包含至少一个第一治疗周期和至少一个第二治疗周期的给药方案，其中所述第一治疗周期包括：（a）将治疗有效量的西他滨或其代谢物施用连续3至5次天为期2周，从第d天开始，其中d是在所述第一治疗周期中用西他滨或其代谢物治疗的第一天; 和（b）在所述第一个治疗周期中相对于施用西来昔布或其代谢物，在第（d-1）天开始，任选地施用治疗有效量的西拉替尼连续3至5天，持续2周; 之后休息至少2周，或直到治疗相关毒性得到解决，以较长者为准; 并且其中所述第二治疗周期包括：（a）从第d天开始，给予治疗有效量的沙美他滨或其代谢物连续3至5个星期，其中d是用西他滨的第一天治疗，或其代谢物，在所述第二处理循环中; 和（b）在所述第二治疗周期中相对于施用西他滨或其代谢物，在第（d-1）天开始，施用治疗有效量的联用西拉霉3至5个连续2周。其次是至少2周的休息期，或直到治疗相关的毒性被解决为止，以较长者为准。本发明的其它方面涉及一组零件和相应的用途。

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