Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy

Exclusion Criteria

• •1. Prior treatment with regorafenib.
• •2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
• •3. Congestive heart failure \>New York Heart Association class 2
• •4. Unstable angina), new-onset angina.Myocardial infarction less than 6 months before start of study drug
• •5. Myocardial infarction less than 6 months before start of study drug.
• •6. Cardiac arrhythmias requiring anti-arrhythmic therapy
• •7. Uncontrolled hypertension.
• •8. Pleural effusion or ascites that causes respiratory compromise
• •9. Ongoing infection \> Grade 2
• •10. Known history of human immunodeficiency virus infection.
• •11. Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
• •12. Subjects with seizure disorder requiring medication.
• •13. History of organ allograft. Subjects with evidence or history of any bleeding diathesis, irrespective of severity.
• •14. Any hemorrhage or bleeding event \> Common Toxicity Criteria for Adverse Effects Grade 3
• •15. Arterial or venous thrombotic or embolic events within the 6 months before start of study medication
• •16. Known history or symptomatic metastatic brain or meningeal tumors
• •17. Suggestive or consistent with central nervous system disease
• •18. Renal failure requiring hemo-or peritoneal dialysis.
• •19. Dehydration Common Toxicity Criteria for Adverse Effects v. 4.0 Grade \>1.
• •20. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
• •21. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
• •22. Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his/her compliance in the study.
• •23. Interstitial lung disease with ongoing signs and symptoms
• •24. Persistent proteinuria of CTCAE Grade 3
• •25. Any malabsorption condition.
• •26. Concomitant participation or participation within the last 30 days in another clinical trial
• •27. Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks before starting to receive study medication.