CONTINUOUS EXPOSURE ORAL PHENYLBUTYRATE 3 TIME DAILY SCHEDULE

每日连续口服苯丁酸 3 次

• 批准号: 6263595
• 负责人: JANE B ALAVI
• 金额: $ 2.51万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 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/6263595
• 关键词: carboxylate; central nervous system neoplasms; clinical research; clinical trial phase I; drug administration rate /duration; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplastic process; oral administration; pharmacokinetics

To determine the maximum tolerated dose of sodium phenyllbutyrate taken orally three times a day in patients with refractory CNS tumors until evidence of tumor progression. To describe the pharmacokinetic parameters of oral phenylbutyrate and to escalate the does of phenylbutyrate in an attempt to achieve plasma levels of 2-6 mmol/L while evaluating patient tolerability on the continuous oral exposure schedule. To seek preliminary evidence of therapeutic activity of phenylbutyrate when administered on this schedule to patients with refractory CNS tumors. To correlate any observed responses and toxicity with results of bioassays and tissue sampling for phenylbutyrate activity.

确定难治性中枢神经系统肿瘤患者每天口服 3 次苯基丁酸钠的最大耐受剂量，直至出现肿瘤进展的证据。描述口服苯丁酸的药代动力学参数，并逐步增加苯丁酸的剂量，以达到 2-6 mmol/L 的血浆水平，同时评估患者对连续口服暴露方案的耐受性。寻求按此方案给予难治性中枢神经系统肿瘤患者苯丁酸治疗活性的初步证据。将任何观察到的反应和毒性与丁酸苯酯活性的生物测定和组织取样结果相关联。