PHI-56: NCI #6813: A PHASE I PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF TEMS

PHI-56：国家癌症研究所

• 批准号: 7982074
• 负责人: Stephen I Shibata
• 金额: $ 10.78万
• 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: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7982074
• 关键词: CCI-779; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Functional disorder; Funding; Grant; Hepatic; Institution; Patients; Pharmacodynamics; Phase; Population; Recommendation; Research; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; cohort

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. The primary objective of this study is to evaluate the safety, tolerability and to establish the maximum tolerated recommended dose (RD) of CCI-779 (temsirolimus) in cohorts of patients with varying degrees of hepatic dysfunction (mild, moderate and severe) in order to provide appropriate dosing recommendations for CCI-779 in this population.

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的主要目的是评价CCI-779（替西罗莫司）在不同程度肝功能障碍（轻度、中度和重度）患者队列中的安全性、耐受性并确定最大耐受推荐剂量（RD），以便为CCI-779在该人群中提供适当的给药建议。