A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer

Tumor tissue collected at baseline and 2 weeks after starting regorafenib will be analyzed
for phosphoproteins and RNA. Peripheral blood samples will be collected and banked for
protein, miRNA, and mutated DNA analysis.

Inclusion Criteria:

- Metastatic colorectal cancer suitable for regorafenib treatment

- Life expectancy of at least 12 weeks

- Able to understand and willing to sign written informed consent form

- Adequate bone marrow, liver, and renal function

- Glomerular filtration rate >/= 60 according to the Modified Diet in Renal Disease
abbreviated formula

- Women of childbearing potential must have a negative serum pregnancy test

- Subject able to swallow and retain oral medication

Exclusion Criteria:

- Previous assignment to treatment in this study

- Uncontrolled hypertension

- Active or clinically significant cardiac disease

- Evidence or history of Bleeding diathesis or coagulopathy

- Any hemorrhage or bleeding even Grade 3 or higher within 4 weeks prior to start of
study medication

- Subjects with thrombotic, embolic, venous or arterial events

- Subjects with any previously untreated or concurrent cancer

- Pheochromocytoma

- Known history of human immunodeficiency virus infection or current chronic or active
hepatitis B or C infection requiring treatment with antiviral therapy

- Ongoing infection Grade 2 or higher

- Symptomatic metastatic brain or meningeal tumors

- Presence of a non-healing wound, non-healing ulcer, or bone fracture

- Renal failure requiring dialysis

- Dehydration Grade 1 or higher

- Seizure disorder requiring medication

- Persistent proteinuria Grade 3 or higher

- Interstitial lung disease with ongoing signs and symptoms at the time of informed
consent

- Pleural effusion or ascites that causes respiratory compromise

- History of organ allograft including corneal transplant

- Known or suspected allergy or hypersensitivity to the study drug

- Any malabsorption condition

- Women who are pregnancy or breast-feeding

- Substance abuse, medical, psychological or social conditions that may interfere with
the subject's participation in the study or evaluation of the study results

- Concurrent anticancer therapy

- Concurrent use of another investigational drug or device therapy during or within 4
weeks of trial entry

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
before start of study medication

- Therapeutic anticoagulation with Vitamin-K antagonists or with heparins and
heparinoids

- Use of any herbal remedy