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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目的是获得耐受性和安全性，并建立CCI-779(替西罗莫司)在不同程度肝功能障碍患者中的MTD，以便在该人群中提供适当的剂量推荐。药代动力学曲线将以不同程度的肝功能为特征，药效学曲线将通过药物对各种标记物的影响来衡量。毒性和肿瘤反应将进行评估。

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.