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: 6586851
• 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
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2002-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6586851
• 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

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.

本方案研究了NSC655649的最大耐受性、单次静脉注射剂量和药代动力学，并评估了每21天给药时的定性和定量毒性。NSC655649是一种具有抗肿瘤特性的抗生素，最初是从放线菌菌株中分离出来的；母体化合物瑞贝卡霉素（Rebeccamycin）从未在人体中进行过测试，而NSC655649是同类药物中第一个进入临床试验的。为了收集更多的研究对象，这项研究已经延长。