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。该研究分为三部分：第一阶段、第二阶段和第三阶段。一期试验的目的是确定二期试验中使用的剂量。非小细胞肺癌、结直肠癌、胰腺癌、胃癌、膀胱癌、前列腺癌、头颈癌或肾细胞癌患者符合进入i期试验的条件。根据连续入组顺序（非癌症类型），估计将累积9例患者，每3组3例患者或9- ac剂量增加，以确认最大耐受剂量和剂量限制性毒性，如果它们在研究水平下发生。IIA期使用的9-AC剂量将根据i期的安全性结果来选择。IIA期的目的是确定用于IIB期的肿瘤类别。在IIA期，至少有14名可评估的患者将被纳入上述8种特定肿瘤类型，总计112名患者。在I期试验中，使用所选剂量水平或更高剂量的患者将根据其特定的肿瘤类型被纳入14名患者的组中。

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.