Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients

Summary

1. Primary Endpoints * Biomarker data suggestive of regorafenib-mediated inhibition of the RAS-RAF- MEK-ERK signal transduction pathway,of various tyrosine kinase receptors and/or of angiogenesis. * Evaluation of potential relationships between biomarker data and clinical activity. * Evaluation of a novel biomarker technology (Prometheus COPIA platform) 2. Secondary Endpoints * Biomarker data suggestive of regorafenib-mediated effects on circulating rare cells. * Comparison of tumor genetic profiles obtained using DNA isolated from plasma, tumor biopsies and circulating tumor cells. * Patient safety data * Pharmacokinetics of regorafenib * Changes in tumor metabolic activity as measured by PET CT scan (optional)

Timeline

Start

2011-01

Primary completion

2013-08

Completion

—

Publications

• Background Goh BC, Fleming GF, Janisch L, Vogelzang NJ, Stadler WM, Ratain MJ. Development of a schedule-dependent population pharmacodynamic model for rhizoxin without quantitation of plasma concentrations. Cancer Chemother Pharmacol. 2000;45(6):489-94. doi: 10.1007/s002800051024.
• Background Vokes EE, Goh BC, Bertucci D, Vogelzang NJ, Mani S, Ratain MJ. A Phase I study of raltitrexed and paclitaxel given every 3 weeks to patients with solid tumors. Cancer. 1999 Aug 1;86(3):528-32.

Drugs

Indications