PHASE I AND PHARMACOKINETIC STUDIES OF ANTICANCER AGENTS

抗癌药物的 I 期研究和药代动力学研究

• 批准号: 3607860
• 负责人: DAVID A VAN ECHO
• 金额: $ 5.46万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 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/3607860
• 关键词: antineoplastics; clinical trials; combination cancer therapy; dosage; drug adverse effect; drug interactions; drug metabolism; drug screening /evaluation; human subject; human therapy evaluation; neoplasm /cancer invasiveness; neoplasm /cancer therapy

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 toxity 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.

本合同的具体目标是：1)定义急性 新的抗癌药对晚期癌症患者的毒性；2) 重新定义抗癌药物的急性毒性和药代动力学 与药物联合使用以调节毒性或抗肿瘤 效果；3)提供有关药代动力学特征的信息 (吸收、分布、代谢和消除)和药效学 选定的抗肿瘤药物；以及4)确定治疗方案 适用于II期临床试验中的抗肿瘤活性评价。