9 AMINOCAMPTOTHECIN IN SOLID TUMORS

这是一项开放标签、非随机、剂量探索、多次给药的I/II期试验， 氨基喜树碱（9-AC）在实体瘤患者中的应用。I期部分的主要目的是使用每日X5时间表确认MTD，以及研究II期部分的β-AC推荐剂量。 I期研究的次要目标是确定安全性特征并研究药效学参数。 II期部分的主要目的是评价9-AC晚期实体瘤（NSCLC、结直肠癌、胰腺癌、胃癌、膀胱癌、前列腺癌、头颈癌和肾细胞癌）住院患者的安全性和临床活性。剂量限制性毒性为中性粒细胞减少，MTD为1.8 mg/m2。尽管PK参数充分，但观察到最小临床活性。

This is an open-label, non-randomized, dose finding, multiple dose Phase I/II trial of 9 aminacamptothecin (9-AC) in patients with solid tumors. The primary objective of the phase I portion is to confirm the MTD using a daily X5 schedule, and recommended dose of (-AC for the phase II portion of the study. Secondary objective of the phase I study is to determine safety profile, and to investigate pharmacodynamics parameters. The primary objective of the phase II portion is to evaluate the safety and clinical activity of 9-AC inpatients with advanced solid tumors (NSCLC, colorectal, pancreatic, gastric, bladder, prostate, head-neck and renal cell). Dose limiting toxicity was neutropenia, and the MTD was 1.8 mg/m2. Minimal clinical activity was observed, despite adequate PK parameters.