PHASE I & CLINICAL PHARMACOKINETICS--ANTICANCER AGENTS

第一阶段

• 批准号: 3607822
• 负责人: MARK J RATAIN
• 金额: $ 10.52万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-05-01 至 1995-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3607822
• 关键词: antineoplastics; chemical information system; clinical trials; drug adverse effect; drug metabolism; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer pharmacology

The specific objectives of this contract are: 1) to define the acute toxicities of new anticancer agents in patients with advanced cancer; 2) to redefine the acute toxicities and pharmacokinetics of anticancer administered in combination with agents to modulate toxicity or antitumor effect; 3) to provide information on the pharmacokinetic characteristics (absorption, distribution, metabolism and elimination) and pharmacodynamics of selected antitumor agents; and 4) to determine a treatment regimen suitable for evaluation of antitumor activity in Phase II trials.

该合同的具体目标是：1）定义急性 晚期癌症患者的新抗癌药的毒性； 2） 重新定义抗癌的急性毒性和药代动力学 与药物结合使用以调节毒性或 抗肿瘤效应； 3）提供有关药代动力学的信息 特征（吸收，分布，代谢和消除） 和选定抗肿瘤剂的药效学； 4）确定 一种适合评估抗肿瘤活性的治疗方案 II期试验。