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

这个子项目是许多研究子项目中的一个 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。 目的是评估CCI-779（替西罗莫司）在不同程度肝功能障碍患者中的耐受性、安全性并确定MTD，以便在该人群中提供适当的给药建议。 将通过不同程度的肝功能表征药代动力学特征，并通过药物对各种标志物的影响进行药效学特征测定。 将评价毒性和肿瘤缓解。

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.