A PHASE I PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF TEMSIROLIMUS (CCI779)

替西罗莫司 (CCI779) 的 I 期药代动力学和药效学研究

• 批准号: 7716723
• 负责人: HEINZ JOSEF LENZ
• 金额: $ 5.05万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-20 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716723
• 关键词: CCI-779; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Functional disorder; Funding; Grant; Hepatic; Institution; Measures; Patients; Pharmaceutical Preparations; Pharmacodynamics; Phase; Population; Recommendation; Research; Research Personnel; Resources; Safety; Source; Toxic effect; United States National Institutes of Health; response; tumor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Objectives are to access tolerability, safety, and to establish the MTD of CCI-779 (temsirolimus) in patients with varying degrees of hepatic dysfunction in order to provide appropriate dosing recommendation in this population. The pharmacokinetic profile will be characterized with varying degrees of hepatic function and the pharmacodynamic profile as measured by drug effects on various markers will be done. Toxicities and tumor response will be evaluated.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 目的是获取耐受性，安全性，并在不同程度的肝功能障碍的患者中建立CCI-779（Temsirolimus）的MTD，以便在该人群中提供适当的给药建议。 药代动力学特征将以不同程度的肝功能来表征，通过药物对各种标记的药物效应来衡量的药效学谱。 将评估毒性和肿瘤反应。