- Prior treatment with regorafenib
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting study drug
- Pregnant or breast-feeding subjects. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of study drug.
- Congestive heart failure >= New York Heart Association (NYHA) class 2
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
- Myocardial infarction less than 6 months before start of study drug
- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Uncontrolled hypertension (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
- Pleural effusion or ascites that causes respiratory compromise (National Cancer Institute Common terminology criteria for adverse events [NCI-CTCAE] v. 4.0 Grade >= 2 dyspnea)
- Ongoing infection NCI-CTCAE v. 4.0 Grade > 2
- Known history of human immunodeficiency virus (HIV) infection
- Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy
- Subjects with seizure disorder requiring medication
- History of organ allograft
- Subjects with evidence or history of any bleeding diathesis, irrespective of severity
- Any hemorrhage or bleeding event NCI-CTCAE v. 4.0 Grade >= 3 within 4 weeks prior to the start of study medication
- Non-healing wound, ulcer, or bone fracture
- Renal failure requiring hemo- or peritoneal dialysis
- Dehydration NCI-CTCAE v. 4.0 Grade >= 1
- Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results
- Known hypersensitivity to the study drug, study drug class, or excipients in the formulation
- Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his / her compliance in the study
- Interstitial lung disease with ongoing signs and symptoms
- Persistent proteinuria of NCI-CTCAE v. 4.0 Grade 3 (> 3.5 g/24 hours)
- Subjects unable to swallow oral medications
- Any malabsorption condition
- Unresolved toxicity higher than NCI-CTCAE v. 4.0 Grade 1 (excluding alopecia, anaemia,and hypothyroidism) attributed to any prior therapy / procedure
- Concomitant participation or participation in another therapeutic trial with investigational new drugs within 30 days or 5 drug half-lives (if drug half life in subjects is known), whichever is shorter
- If any other approved tyrosine kinase inhibitor was given within 1 week or a minimum of 5 drug half-lives whichever is longer (i.e. within 7 days for imatinib, or within 10 days for sunitinib)