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PHASE I STUDY OF NSC 655649 GIVEN BY BOLUS INFUSION EVERY 21 DAYS

PHASE I STUDY OF NSC 655649 GIVEN BY BOLUS INFUSION EVERY 21 DAYS
每 21 天推注一次的 NSC 655649 I 期研究
批准号：
6450088
负责人：
S. Gail Eckhardt
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：
2000
资助国家：
美国
项目状态：
已结题
起止时间：
2000-12-01 至 2001-11-30
来源：
https://reporter.nih.gov/project-details/6450088
关键词：
antineoplastic antibiotics clinical research clinical trial phase I drug administration rate /duration drug screening /evaluation human subject human therapy evaluation injection /infusion intravenous administration neoplasm /cancer chemotherapy pharmacokinetics

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中文摘要
翻译
本方案研究了NSC 655649的最大耐受、单次静脉给药剂量和药代动力学，并评价了每21天推注给药时药物的定性和定量毒性。 NSC 655649是一种具有抗肿瘤特性的抗生素，最初从放线菌菌株中分离出来;母体化合物曲卡霉素从未在人体中进行过测试，NSC 655649是第一个进入临床试验的抗生素。 这项研究已经延长，以增加更多的受试者。
英文摘要
This protocol investigates the maximum tolerated, single intravenous dosage and pharmacokinetics of NSC655649 and evaluates the qualitative and quantitative toxicities of the drug when administered as a bolus infusion every 21 days. NSC655649 is an antibiotic with antitumor properties originally isolated from an actinomycete strain ; the parent compound, Rebeccamycin, has never been tested in humans and NSC655649 is the first of the class to go into clinical trials. The study has been extended in order to accrue additional subjects.
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Southwest Early Clinical Trials Consortium
Southwest Early Clinical Trials Consortium
Southwest Early Clinical Trials Consortium
Southwest Early Clinical Trials Consortium
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