Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM

Summary

PURPOSE AND OBJECTIVES: Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS. Secondary Objectives To evaluate the safety and toxicity of combination therapy using Sorafenib plus temozolomide; To determine the pharmacokinetics of Sorafenib when combined with temozolomide in patients on and not on concurrent EIAC medications.

Timeline

Start

2007-09

Primary completion

2009-02

Completion

2010-12

Publications

• Results Reardon DA, Vredenburgh JJ, Desjardins A, Peters K, Gururangan S, Sampson JH, Marcello J, Herndon JE 2nd, McLendon RE, Janney D, Friedman AH, Bigner DD, Friedman HS. Effect of CYP3A-inducing anti-epileptics on sorafenib exposure: results of a phase II study of sorafenib plus daily temozolomide in adults with recurrent glioblastoma. J Neurooncol. 2011 Jan;101(1):57-66. doi: 10.1007/s11060-010-0217-6. Epub 2010 May 5.

Drugs

Indications