9 AMINOCAMPTOTHECIN IN SOLID TUMORS

这是一项9氨基喜树碱(9-AC)在实体瘤患者中的开放标签、非随机、剂量发现、多剂量I/II期试验。第一阶段部分的主要目标是使用每日X5时间表和研究第二阶段部分的推荐剂量(-AC)来确认MTD。第一阶段研究的次要目标是确定安全性，并研究药效学参数。第二阶段的主要目标是评估9-AC治疗晚期实体肿瘤(非小细胞肺癌、结直肠、胰腺、胃、膀胱、前列腺、头颈和肾细胞)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。尽管有足够的PK参数，但仍观察到最低的临床活动度。

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.