CLINICAL TRIAL: NCI 6858: A PHASE 1 STUDY OF SUBEROYLANILIDE HYDROXAMIC ACID (S

临床试验：NCI 6858：辛二酰苯胺异羟肟酸 (S

• 批准号: 7950875
• 负责人: John David Roberts
• 金额: $ 2.43万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950875
• 关键词: Acute leukemia; Clinical; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Funding; Gene Expression; Grant; Induction of Apoptosis; Institution; Maximum Tolerated Dose; Pattern; Pharmacodynamics; Phase; Phase I Clinical Trials; Research; Research Personnel; Resources; Safety; Source; Therapeutic Effect; Toxic effect; United States National Institutes of Health; Vorinostat; cancer cell; flavopiridol; leukemia; response

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. Administration of flavopiridol with SAHA will result in extensive induction of apoptosis of cancer cells with enhanced therapeutic effects (1) Identify recommended phase II doses for the combination of flavopiridol and vorinostat in the treatment of acute leukemia; (2) Determine the safety, toxicities, tolerability, and maximum tolerated dose of the combination; (3) Observe clinical anti-leukemic effects of the combination; (4) Observe pharmacodynamic effects of the combination; (5) Observe the pharmacokinetics of each agent when administered in combination; (5) Observe leukemia gene expression patterns and correlate with response to treatment.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 Flavopiridol与SAHA联用可广泛诱导癌细胞凋亡，增强治疗效果 (1)确定Flavopiridol和vorinostat联合治疗急性白血病的II期推荐剂量;（2）确定联合用药的安全性、毒性、耐受性和最大耐受剂量;（3）观察联合用药的临床抗白血病作用;（4）观察联合用药的药效学作用;（5）观察联合用药时各药物的药代动力学;（5）观察白血病基因表达谱及其与治疗反应的关系。