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

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， 因此可以在其他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。 这是一项E7389软海绵素类似物治疗晚期尿路上皮癌患者的II期、多中心、联合研究，以及一项在中度和重度肾功能不全患者中进行的安全性导入I期研究。 I期研究的目的是观察D 7389是否可以安全地用于中度和重度肾功能不全患者，并描述该组的PK特征。 II期部分的目的是确定一线治疗中晚期尿路上皮癌患者的缓解情况。 将记录与晚期尿路上皮癌和不同程度肾功能不全患者给予E7389相关的毒性。

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.