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: 6116028
• 负责人: BARBARA A BURTNESS
• 金额: $ 2.99万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6116028
• 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

Objectives are: 1) determine the maximum tolerated dose level (MTD) and corresponding rest period; 2) characterize the dose-limiting toxicities (DLT); 3) characterize plasma and urine pharmacokinetics/ pharmacodynamics; 4) document evidence of antitumor activity when feasible; and 5) using NMR, test for the presence of MDL 101,731 and its flourinated metabolites in plasma and urine and in tissues when feasible. An estimated maximum of 40 adult patients will be enrolled. Patients will have advanced solid malignancies for which no standard curative therapy exists. They will be either naive or refractory to treatment (medication and radiation).

目的是：1）确定最大耐受剂量水平（MTD）， 相应的休息期; 2）描述剂量限制性毒性 (DLT); 3）表征血浆和尿液药代动力学/ 药效学; 4）记录抗肿瘤活性的证据， 可行;和5）使用NMR，检测MDL 101，731及其 血浆、尿液和组织中的氟化代谢物， 可行 估计最多将入组40例成人患者。 患者将患有晚期实体恶性肿瘤， 存在治愈性疗法。他们要么天真，要么顽固， 治疗（药物和放射治疗）。