PHII-51: A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF SB-715992 GIVEN WEEKLY

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。本研究的主要目的是确定SB-715992治疗晚期或转移性结直肠癌患者的有效率，每周一次，共3周，每28天一次，SB-715992每21天一次。次要目标将表征SB-715992的群体PK参数：检查血液单个核细胞和肿瘤的细胞骨架形态变化；评估档案肿瘤组织中的信使核糖核酸；确定SB-715992靶向基因的基因组多态频率，并评估它们是否与毒性和临床结果相关。

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 study's primary objective is to determine the response rate in patients with advanced or metastatic colorectal cancer treated with SB-715992 once a week for 3 wks, every 28 days and SB-715992 once every 21 days. Secondary objectives will characterize population PK parameters of SB-715992: examine cytoskeletal morphology changes in blood mononuclear cells and tumors; evaluate mRNA in archival tumor tissue; and determine frequency of genomic polymorphisms in genes targeted by SB-715992 and to assess whether they are associated with toxicity and clinical outcome.