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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
BMS-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上级的疗效。 这是该药物的首次临床试验。 这是一项开放标签、单组、I期剂量递增研究，目的是确定标准治疗失败或无标准治疗的非血液学恶性肿瘤患者每三周输注1小时时试验药物的剂量限制性毒性、最大耐受剂量、II期剂量和安全性。 本研究还将检查BMS-184476及其潜在代谢产物的药代动力学，并描述抗肿瘤活性的任何初步证据。
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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