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PHASE I STUDY OF BMS 184476 IN PATIENTS W/ ADVANCED MALIGNANCIES

PHASE I STUDY OF BMS 184476 IN PATIENTS W/ ADVANCED MALIGNANCIES
BMS 184476 在晚期恶性肿瘤患者中的 I 期研究
批准号：
6586830
负责人：
ERIC K ROWINSKY
金额：
$23.48万
依托单位：
UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
项目状态：
已结题
起止时间：
2001-12-01 至 2002-11-30
来源：
https://reporter.nih.gov/project-details/6586830
关键词：
antineoplastics clinical research clinical trial phase I drug screening /evaluation human subject human therapy evaluation neoplasm /cancer chemotherapy neoplastic growth neoplastic process pharmacokinetics

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中文摘要
翻译
184476是一种紫杉烷，在体内和体外实验模型中显示出与紫杉醇相同或更好的疗效。这是该药物的首次临床试验。这是一项开放标签的单臂I期剂量递增研究，其目的是确定研究药物的剂量限制毒性、最大耐受剂量、第二阶段剂量和安全性，当研究药物每三周通过一小时输液给药时，用于标准治疗失败或没有标准治疗的非血液系统恶性肿瘤患者。这项研究还将检查BMS-184476及其潜在代谢物的药代动力学，并描述任何抗肿瘤活性的初步证据。
英文摘要
BMS-184476 is a taxane that displays efficacy equal or superior to Taxol in both in vivo and in vitro experimental models. This is the first clinical trial for the drug. It is an open-label, single arm, Phase I dose escalation study the purpose of which is to determine dose-limiting toxicity, maximum tolerated dose, Phase II dose and safety of the investigational agent when administered every three weeks by a one-hour infusion to patients with non-hematologic malignancies who have failed standard therapy or for whom no standard therapy exists. The study will also examine the pharmacokinetics of BMS-184476 and its potential metabolites and describe any preliminary evidence of antitumor activity.
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