A STUDY OF SORAFENIB (BAY 43-9006) AND BLOOD PRESSURE

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。 索拉非尼是FDA于2005年12月批准的一种新型抗癌药物。 在最初的临床试验中，10%的受试者出现高血压。 对非标准化数据的进一步回顾性分析表明，血压可能是接受该药物治疗的患者的常见事件，并且这些升高可能预测肿瘤对治疗的反应性。 本研究的目的是更准确地描述血压和血液中药物浓度之间的关系，并解释与这种效应的个体间变异性相关的主要因素。 多项外部研究报告称，由于索拉非尼的机制作用，观察到了显著效果。 本研究收集的其他数据将有助于表征生物标志物与药物之间的任何可能关系;包括血浆蛋白水平对血液药物水平的反应变化，利用报告的涉及显著效应的患者毒性（包括低磷血症）和特定CAT扫描研究对腺体器官血管的消退效应。

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. Sorafenib is a new anti-cancer drug recently approved by the FDA in December 2005. During its initial clinical trials, hypertension was noted among 10% of subjects. Further retrospective analysis of non-standardized data suggested that blood pressure may be a frequent occurrence of patients on treatment with this drug, and that these elevations may predict tumor responsiveness to therapy. The purpose of this study is to more accurately characterize the relationship between blood pressure and drug concentration in the blood, and to account for the major factors associated with the interindividiual variability seen of this effect. Various outside studies reported observing marked effects due to the mechanistic effects of sorafenib. Other data collected from this study will help characterize any possible relationships between biomarkers and the drug; including plasma protein level changes in response to blood drug levels, utilizing patient toxicities reported to implicate significant effects, including hypophosphatemia, and specific CAT scans to study the regression effect on blood vessels in glandular organs.