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

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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.