Asian Colorectal Cancer Patients Clinical Trial
Official title:
Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients
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)
n/a
Primary Purpose: Treatment