课题基金 / 基金详情

9 AMINOCAMPTOTHECIN IN SOLID TUMORS

9 AMINOCAMPTOTHECIN IN SOLID TUMORS
9 实体瘤中的氨基喜树碱
批准号：
6303055
负责人：
FRANCISCO ROBERT
金额：
$2.95万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
项目状态：
已结题
起止时间：
1999-12-01 至 2000-11-30
来源：
https://reporter.nih.gov/project-details/6303055
关键词：
antineoplastics bladder neoplasm camptothecin clinical research clinical trial phase I colorectal neoplasms dosage drug adverse effect drug screening /evaluation gastrointestinal neoplasms head /neck neoplasm human subject human therapy evaluation kidney neoplasms neoplasm /cancer chemotherapy nonsmall cell lung cancer pancreas neoplasms prostate neoplasms

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中文摘要
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英文摘要
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.
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