9 AMINOCAMPTOTHECIN IN SOLID TUMORS

这是一项多中心、开放标签、多剂量、非安慰剂对照的I/II期研究。研究分为三个部分，即第一阶段、第二阶段IA和第二阶段B。第一阶段部分的目的是确定第二阶段部分要使用的剂量。患有非小细胞肺癌、结直肠癌、胰腺癌、胃腺癌、膀胱癌、前列腺癌、头颈癌或肾细胞癌的患者有资格进入第一阶段。估计有9名患者(3组各3名患者或9-AC剂量递增)将根据连续的登记顺序(不是癌症类型)进行累积，以确认最大耐受剂量和剂量限制毒性，如果它们发生在研究的水平上。将根据I期的安全性结果选择用于IIA期部分的9-AC剂量。IIA期的目的是确定用于IIB期的肿瘤类别。在IIA阶段，至少14名可评估的患者将为上面列出的8种特定肿瘤类型中的每一种进行登记，总计112名患者。第一阶段中处于选定剂量水平或更高水平的患者将被纳入针对其特定肿瘤类型的14名患者。

This is a multicenter, open label, multiple dose, non-placebo controlled Phase I/II study. There are three parts of the study, Phase I, Phase IIA, and Phase IIB. The purpose of the Phase I part is to determine a dose to be used in the Phase II part. Patients with nonsmall cell lung, colorectal, pancreatic, gastric, bladder, prostate, head and neck cancers or renal cell are eligible for entry in Phase I. An estimated 9 patients, three patients in each of 3 groups or dose escalations of 9-AC, will be accrued based on consecutive order of enrollment (not cancer type) to confirm the maximum tolerated dose and dose limiting toxicities, should they occur at the levels studied. A dose of 9-AC to be used inthe Phase IIA part will be chosen based on the safety results from Phase I. The purpose of Phase IIA is to determine a tumor category to be used in Phase IIB. In Phase IIA, at least 14 evaluable patients will be enrolled for each of the 8 specific tumor types listed above for a total of 112 patients. Patients in the Phase I part who were at the chosen dose level or higher will be included in the group of 14 patients for their particular tumor type.