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

PHII-51：每周进行的 SB-715992 随机 2 期非比较研究

• 批准号: 7368223
• 负责人: SYMA IQBAL
• 金额: $ 16.77万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7368223
• 关键词: PHII; 51; RANDOMIZED; PHASE; NON

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。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。次要目标将表征 SB-715992 的群体 PK 参数：检查血液单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 mRNA；确定 SB-715992 靶向基因的基因组多态性频率，并评估它们是否与毒性和临床结果相关。