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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项 SAHA 的 I 期试验，以递增剂量口服给药，并与每周两次静脉注射的硼替佐米（第 1、4、8 和 11 天）联合使用。该循环每 3 周重复一次。该研究将确定该组合的安全剂量。研究开始时，3 名患者将接受低剂量 SAHA 和硼替佐米治疗。如果该剂量不会引起严重的副作用，则随着新患者参与研究，该剂量将逐渐增加。患者将在门诊服用这种药物组合最多 8 个周期（24 周）。仅在第 1 周期的第 4 天进行 8 小时的药代动力学评估。