CLINICAL TRIAL: LCCC 0509: A TWO-ARM PHASE I DOSE ESCALATION TRIAL OF VINFLUNINE

临床试验：LCCC 0509：Vinflunine 的双臂 I 期剂量递增试验

• 批准号: 7716861
• 负责人: ELIZABETH CLAIRE DEES
• 金额: $ 1.55万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716861
• 关键词: CYP3A4 gene; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Enrollment; Erlotinib; Funding; Grant; Institution; Label; Maximum Tolerated Dose; Midazolam; Patients; Pemetrexed; Phase; Randomized; Refractory; Research; Research Personnel; Resources; Solid Neoplasm; Source; United States National Institutes of Health; Upper arm; vinflunine

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 an open label, non-randomized phase I dose escalation trial in refractory solid tumors. Patients will be enrolled to one of two arms, vinflunine/erlotinib or vinflunine/pemetrexed, to define the maximum tolerated doses (MTD) of each combination. We will also investigate whether vinflunine is a CYP3A4 substrate, and if CYP3A4 activity predicts vinflunine clearance with the use of a midazolam CYP3A4 probe.

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。 这是一项在难治性实体瘤中进行的开放标签、非随机I期剂量递增试验。 患者将被招募到两个组之一，长春氟宁/厄洛替尼或长春氟宁/培美曲塞，以定义每个组合的最大耐受剂量（MTD）。我们亦会研究 长春氟宁是否为CYP 3A 4底物，以及CYP 3A 4活性是否预测使用咪达唑仑CYP 3A 4探针的长春氟宁清除率。