PHI-39: PHASE I TRIAL OF #7389 (HALICHONDRIN B ANALOG) (NSC #707389)

PHI-39：第一阶段试验

• 批准号: 7368162
• 负责人: ROBERT O. MORGAN
• 金额: $ 1.09万
• 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/7368162
• 关键词: PHI; 39; PHASE; TRIAL; #7389

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. The Objectives are: To determine the maximum tolerated dose (MTD) of E7389 administered as an IV bolus over 1-2 minutes weekly for 3 weeks; to describe the toxicities of E7389; to evaluate the pharmacokinetics of E7389; whenever feasible, to determine the in vivo anti-mitotic activity of E7389 by cell cycle analysis and immunohistochemistry in pre- and post-treatment tumor biopsies. Once the MTD of E7389 has been determined, an additional 10 patients with biopsy-accessible tumors will be enrolled to make a preliminary assessment of target validation feasibility.

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。目标是：确定E7389每周1-2分钟IV推注给药持续3周的最大耐受剂量（MTD）;描述E7389的毒性;评价E7389的药代动力学;在可行的情况下，通过治疗前和治疗后肿瘤活检组织中的细胞周期分析和免疫组织化学确定E7389的体内抗有丝分裂活性。一旦确定了E7389的MTD，将招募另外10例活检可及肿瘤患者，对靶点验证可行性进行初步评估。