0514 GCC: A PHASE 1 STUDY OF SAHA IN COMBINATION WITH BORTEZOMIB IN RELAPSED

0514 GCC：SAHA 联合硼替佐米治疗复发的第一阶段研究

• 批准号: 7608162
• 负责人: Ashraf Z Badros
• 金额: $ 6.1万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608162
• 关键词: Adverse effects; Bortezomib; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Combinations; Drug Kinetics; Funding; Grant; Hour; Institution; Oral cavity; Outpatients; Patients; Phase I Clinical Trials; Relapse; Research; Research Personnel; Resources; Source; United States National Institutes of Health; Vorinostat; Week; base; day

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase I trial of SAHA administered by mouth in increasing dose in combination with bortezomib given intravenously twice weekly (days 1 and 4,8 and 11). The cycles are repeated every 3 weeks. The study will establish the safe dose that can be given for this combination. At the beginning of the study 3 patients will be treated with a low dose of SAHA and Bortezomib. If this dose does not cause severe side effects it will gradually be increased as new patients take part in the study. Patients will take this combination of drugs for up to 8 cycles (24 weeks) on an outpatient basis. An 8 hour pharmacokinetic assessment will be done on day 4 of cycle 1 only.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项I期试验，SAHA口服递增剂量联合博替佐米每周两次静脉注射(第1、4、8和11天)。这些周期每3周重复一次。这项研究将确定这种组合可以给予的安全剂量。在研究开始时，3名患者将接受低剂量的Saha和Bortezomib治疗。如果这种剂量不会引起严重的副作用，它将随着新患者参与研究而逐渐增加。患者将在门诊基础上服用这种药物组合，最长可达8个周期(24周)。仅在第1周期的第4天进行8小时药代动力学评估。