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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。目的：确定E7389的最大耐受剂量（MTD），每周静脉注射1-2分钟，持续3周；描述E7389的毒性；评价E7389的药代动力学；在可行的情况下，通过治疗前后肿瘤活检的细胞周期分析和免疫组织化学检测E7389的体内抗有丝分裂活性。一旦确定了E7389的MTD，将再入组10例活检可及的肿瘤患者，初步评估靶点验证的可行性。

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.