NCT01189903

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Asian Colorectal Cancer Patients

Interventions

Type	Name	Description
DRUG	Regorafenib

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-08-01
• First posted: 2010-08-27
• Last updated: 2014-01-28

Locations

1 site across 1 country: Singapore