口服铂类药物沙铂胶囊的Ⅰ期临床研究  

A phase Ⅰ study of satraplatin capsule,an oral platinum compound

作　　者：杨林[1] 王金万[1] 宋岩[1] 董英[1] 李树婷[1] 张和平[1] 

机构地区：[1]中国医学科学院肿瘤医院内科,北京100021

出　　处：《中国新药杂志》2011年第10期895-899,913,共6页Chinese Journal of New Drugs

摘　　要：目的:沙铂是第一个在体外被证实与顺铂有同样抗肿瘤活性的口服铂类药物。本剂量递增(20,40,70,80,100 m.gm-2.d-1)Ⅰ期临床研究目的是评价人体对沙铂胶囊的耐受性,确定其在人体的最大耐受剂量(MTD)。方法:共纳入21例晚期恶性肿瘤患者。所有患者均可进行安全性分析。给予口服沙铂胶囊,qd,连续5 d,每21 d重复。结果:MTD为100 m.gm-2.d-1,剂量限制性毒性为呕吐、腹泻和血小板下降。其他常见不良反应还包括白细胞下降、中性粒细胞下降、疲乏、蛋白尿。结论:推荐Ⅱ期临床给药剂量为80 m.gm-2.d-1,连用5 d,每28～35 d为1周期。Objective： Satraplatin is the first orally given platinum compounds that shows an in vitro activity comparable to cisplatin.The aim of this phase Ⅰ study was to establish the maximum tolerated dose（MTD） of satraplatin at escalating-doses of 20,40,70,80,and 100mg·m-2·d-1.Methods： Twenty one patients with advanced cancer were enrolled and all patients were assessable for toxicity analysis.Satraplatin capsule were administered orally once a day for 5 consecutive days and repeated every 21 days.Results： The MTD was 100mg·m-2·d-1,and dose-limiting toxicities were vomiting,diarrhea and thrombocytopenia.Other common adverse effects included leucopenia,neutropenia,fatigue and proteinuria.Conclusion： The recommended dose of satraplatin for phase Ⅱ studies were 80mg·m-2·d-1 for 5 days every 28～35 days.

关 键 词：铂类化合物 沙铂 最大耐受剂量 

分 类 号：R979.1[医药卫生—药品]