- Prior treatment with regorafenib
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting regorafenib
- Pregnant or breast-feeding patients. 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 regorafenib.
- 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 regorafenib
- 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’s 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
- Patients with seizure disorder requiring medication
- History of organ allograft
- Patients 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 regorafenib
- 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 patient’s participation in the program
- Known hypersensitivity to regorafenib, the drug class, or excipients in the formulation
- Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his / her compliance in the program
- Interstitial lung disease with ongoing signs and symptoms
- Persistent proteinuria of NCI-CTCAE v.4.0 Grade 3 (> 3.5 g/24 hours)
- Patients 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 within the last 30 days in a clinical trial
- Non-permissible concomitant medications and procedures (systemic anti-cancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy and hormonal therapy or any experimental therapies; Tyrosine Kinase Inhibitors (TKIs); bone marrow transplant or stem cell rescue; use of biologic response modifiers, such as granulocyte colony stimulating factor (G CSF), within 3 weeks prior to entering the program; St John’s Wort; grapefruit and grapefruit juice; all traditional medicines with an anti-cancer indication)