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

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。其目的是：确定E7389每周静脉注射1-2分钟的最大耐受量(MTD)；描述E7389的毒性；评价E7389的药代动力学；尽可能通过细胞周期分析和免疫组织化学方法在治疗前后的肿瘤活检中确定E7389的体内抗有丝分裂活性。一旦确定了E7389的MTD，将再招募10名有活检可及肿瘤的患者，对靶点验证的可行性进行初步评估。

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.