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Asian Colorectal Cancer Patients clinical trials

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NCT ID: NCT01189903 Active, not recruiting - Clinical trials for Asian Colorectal Cancer Patients

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

Start date: January 2011
Phase: Phase 2/Phase 3
Study type: Interventional

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)