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

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。 这是一项针对难治性实体肿瘤的开放式、非随机化的I期剂量递增试验。患者将被纳入两种药物中的一种，长春花碱/厄洛替尼或长春花碱/培美曲塞，以确定每种组合的最大耐受剂量(MTD)。我们还将调查 长春花碱是否是细胞色素P3A4底物，以及使用咪达唑仑细胞色素P3A4探针，细胞色素P3A4活性是否可以预测长春花碱的清除。

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.