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

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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.