Overview

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

Status:
Unknown status

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

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)

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

National University Hospital, Singapore

Treatments:

Niclosamide