A PHASE I PHARMACOKINETIC STUDY OF EPOTHILONE B ANALOGUE BMS-247550 (NSC-170428D

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。在这项I期研究中，BMS-247550将用于不同程度肝功能障碍的患者。根据肝功能将患者分为4组。BMS-247550静脉滴注3小时。目的是确定需要调整BMS-247550剂量的肝功能损害水平；观察肝功能障碍对BMS-247550血浆药代动力学的影响；并确定不同肝功能障碍水平下BMS-247550剂量相关的毒性。这是SWOG的合作小组试验。

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. In this Phase I study BMS-247550 will be given to patients with varying levels of liver dysfunction. Patients will be stratified into 4 groups depending on liver function. BMS-247550 will be given IV as a 3-hr infusion. The objectives will be to define levels of hepatic impairment at which dose modification of BMS-247550 is required; to characterize the effects of hepatic dysfunction on the plasma pharmacokinetics of BMS-247550; and to define toxicities associated with dosing of BMS-247550 at varying levels of hepatic dysfunction. This is a cooperative group trial from SWOG.