PHASE I MULTIPLE DOSE, DOSE ESCLATION TRIAL OF MDL 101,731

MDL 101,731 的 I 期多次剂量、剂量升级试验

• 批准号: 6247146
• 负责人: BARBARA A BURTNESS
• 金额: $ 2.68万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-04-01 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6247146
• 关键词: clinical research; clinical trial phase I; deoxycytidine; dosage; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; outcomes research

Five patients have been enrolled on the first dose level. Dose limiting toxicity was seen in 2, according to conservative DLT criteria used because of concerns regarding cumlative toxicity. The protocol has been amended to more standard DLT criteria, as no cumlative toxicity was observed, and 3 patients are awaiting accrual.

第一个剂量水平入组了5例患者。剂量限制 根据使用的保守DLT标准，在2例中观察到毒性 因为担心累积毒性。研究方案进行了 修订为更标准的DLT标准，因为没有累积毒性。 已观察到，3名患者正在等待招募。