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

索拉非尼 (BAY 43-9006) 和血压的研究

• 批准号: 7604765
• 负责人: Michael L. Maitland
• 金额: $ 6.46万
• 依托单位: UNIVERSITY OF CHICAGO
• 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 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604765
• 关键词: Accounting; Antineoplastic Agents; BAY 54-9085; Biological Markers; Blood; Blood Pressure; Blood Vessels; Blood drug level result; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Disease regression; Elevation; Funding; Grant; Hypertension; Hypophosphatemia; Institution; Organ; Patients; Pharmaceutical Preparations; Plasma Proteins; Purpose; Reporting; Research; Research Personnel; Resources; Source; Toxic effect; United States Food and Drug Administration; United States National Institutes of Health; X-Ray Computed Tomography; response; tumor

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.

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。 索拉非尼是FDA最近于2005年12月批准的一种抗癌新药。在最初的临床试验中，在10%的受试者中发现了高血压。对非标准化数据的进一步回顾分析表明，血压可能是接受该药物治疗的患者的常见症状，这些升高可能预示着肿瘤对治疗的反应性。这项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，并解释与这种影响的个体间变异性相关的主要因素。 各种外部研究报告称，由于索拉非尼的机械作用，观察到了显著的效果。从这项研究中收集的其他数据将有助于描述生物标记物和药物之间任何可能的关系；包括血浆蛋白水平对血液药物水平的反应，利用据报道可能产生重大影响的患者毒性，包括低磷血症，以及特定的CAT扫描，以研究腺器官血管的退化效应。