A PHASE I/II STUDY OF E7389 HALICHONDRIN B ANALOG IN METASTATIC UROTHELIAL TR

University Of Southern California, Los Angeles CA

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Abstract

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. This is a Phase II multi-centered, consortium study of E7389 Halichondrin analog for patients with advances urothelial tract carcinomas with a safety lead-in phase I study in patients with moderate and severe renal dysfunction. The phase I objectives are to see if D7389 can be safely given to patients with moderate and severe renal dysfunction and to characterize the PK profile in this group. The objectives of the phase II portion are to detemine response of patients with advanced urothelial cancers in the first line setting. Toxicities associated with administration of E7389 to patients with advanced urothelial cancer and varying degrees of renal dysfunction will be documented.