胶束载体系统的基本原理及临床试验

Y. Matsumura
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引用次数: 2

摘要

NK911是第一个成功的聚合物胶束系统,通过5PR影响在实体肿瘤中显著积累。该胶束由聚乙二醇(PEG)和聚天冬氨酸部分偶联的阿霉素嵌段共聚物组成。这项I期研究的主要目的是确定最大耐受剂量(MTD)、剂量限制性毒性(dlt)和II期推荐剂量(RD),每3周给实体肿瘤患者静脉输注10mg DXR当量/分钟。剂量递增是基于加速滴定法,然后是改进的斐波那契方法。起始剂量为6.0 mg/m2(大鼠LD10的1/10)。不允许在病人体内增加剂量。
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Basic Aspects and Clinical Trials of Micelle Carrier System
NK911 is the first successful polymeric micelle system directed to remarkable accumulation in solid tumor through 5PR affect. The micelle consists of block copolymer of polyethylene glycol (PEG) and poly (aspartic acid) partially conjugated doxorubicin. The main objectives of this phase I study were to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and the recommended dose (RD) for phase II given every 3 weeks as a 10 mg DXR equivalent/min iv infusion to patients with solid tumors. Dose escalation is based on the accelerated titration method followed by a modified Fibonacci method. The starting dose was 6.0 mg/m2 (1/10 of rat LD10). No intrapatient dose escalation was allowed.
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