Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients

Summary

This is an open-label, non-randomized Phase I study of sorafenib 400 mg bid (2 x 200 mg tablets) in cancer patients. The primary objective of the study is to evaluate the effect of sorafenib on cardiovascular safety parameters. The secondary objectives are to evaluate the safety, pharmacokinetics, and anti-tumor activity of sorafenib in cancer patients

Timeline

Start

2005-08

Primary completion

2007-02

Completion

2008-03

Publications

• Results Tolcher AW, Appleman LJ, Shapiro GI, Mita AC, Cihon F, Mazzu A, Sundaresan PR. A phase I open-label study evaluating the cardiovascular safety of sorafenib in patients with advanced cancer. Cancer Chemother Pharmacol. 2011 Apr;67(4):751-64. doi: 10.1007/s00280-010-1372-3. Epub 2010 Jun 3.

Drugs

Indications