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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究的主要目的是确定晚期或转移性结直肠癌患者接受SB-715992治疗的缓解率，每周一次，持续3周，每28天一次，以及SB-715992每21天一次。次要目的将表征SB-715992的群体PK参数：检查血液单核细胞和肿瘤中的细胞骨架形态学变化;评价存档肿瘤组织中的mRNA;确定SB-715992靶向基因中基因组多态性的频率，并评估其是否与毒性和临床结局相关。

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.