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利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项针对晚期尿路上皮癌患者的E7389灯盏花素类似物的II期多中心联合研究，在中度和严重肾功能障碍患者中进行安全的I期研究。第一阶段的目标是看看D7389是否可以安全地应用于中、重度肾功能不全患者，并确定这一组患者的PK特征。II期部分的目标是确定一线治疗的晚期尿路上皮癌患者的反应。与使用E7389治疗晚期尿路上皮癌和不同程度肾功能障碍的患者相关的毒性将被记录在案。

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.