This is a Phase IV, single-arm, prospective, open-label, multicenter, interventional study to evaluate safety and efficacy of regorafenib in patients with mCRC who have been previously treated with fluoropyrimidine , oxaliplatin-, and irinotecan based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.

Inclusion Criteria:

• Male or female patients (≥18 years of age) with metastatic (Stage IV) colorectal adenocarcinoma confirmed either histologically or cytologically, with measurable metastatic disease according to RECIST v. 1.1
• Patients must have PD after receiving the approved standard therapies
• Patients must have ECOG PS of 0 or 1 and a life expectancy of at least 3 months
• Adequate bone marrow, liver and renal function
• Women of childbearing potential and men must agree to use adequate contraception

Exclusion Criteria:

• Unresolved toxicity greater than Grade 1 from prior treatment for mCRC
• Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s)
• Subjects unable to swallow oral medications
• Any malabsorption condition
• Any medical or surgical conditions within 28 days before start of regorafenib that will interfere with patient's participation in the study

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.