SAFETY, TOLERANCE & PK STUDY OF RISING DOSE MSI 1256F (SQUALAMINE LACTATE)

安全、宽容

• 批准号: 6265609
• 负责人: S. Gail Eckhardt
• 金额: $ 1.64万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265609
• 关键词: antineoplastics; cholestane compound; clinical research; clinical trial phase I; dosage; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplastic process; pharmacokinetics

The study drug, squalamine lactate, inhibits growth of solid tumors by inhibiting the development of a blood supply to the tumor without direct cytotoxicity to tumor cells. It has not been previously tested in human subjects. The purposes of this study are to determine the maximum tolerated dosage, determine the qualitative and quantitative toxicity charcteristics, determine the recommended dose as a continuous five day infusion, and characterize the pharmacokinetic and pharmacodynamic charcteristcs of the drug.

研究药物，角鲨胺乳酸，通过抑制肿瘤血液供应的发展来抑制实体肿瘤的生长，而不对肿瘤细胞产生直接的细胞毒性。此前还没有在人类身上进行过测试。本研究的目的是确定最大耐受剂量，确定定性和定量毒性特征，确定连续5天输注的推荐剂量，并表征药物的药代动力学和药效学特征。