9 AMINOCAMPTOTHECIN IN SOLID TUMORS

这是一种多中心、开放标签、多剂量、非安慰剂对照的药物 I/II期研究。研究分为三个部分：第一阶段；第一阶段 IIA期；以及IIB期。 第一阶段的目的是确定第二阶段要使用的剂量。 非小细胞肺癌、结直肠、胰腺、胃、 膀胱癌、前列腺癌、头颈部癌或肾癌均符合条件 对于进入I期的患者，估计有9名患者，每个患者3名 9-AC的三组或剂量递增将根据 连续登记顺序(非癌症类型)以确认最大值 耐受剂量和剂量限制毒性，如果它们发生在 所研究的水平。 将根据安全性选择在IIA期使用的9-AC剂量 第一阶段的结果IIA阶段的目的是确定肿瘤 第二阶段B中使用的类别。在IIA阶段，至少有14个可评估 将为列出的8种特定肿瘤类型的患者进行登记 以上共112例患者。第一阶段的患者，他们在 选定的剂量水平或更高的剂量将包括在14名患者中 针对他们特定的肿瘤类型。

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 Phase I is to determine a dose to be used in Phase II. Patients with nonsmall cell lung, colorectal, pancreatic, gastric, bladder, prostate, head and neck cancers or renal cell cancer are eligible for entry in Phase I. An estimated 9 patients, three patients in each of three 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 ocur at the levels studied. A dose of 9-AC to be used in Phase IIA 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 Phase I who were at the chosen dose level or higher will be included in the group of 14 patients for their particular tumor type.