Regorafenib in Metastatic Colorectal Cancer

Inclusion Criteria

• Histologically confirmed colorectal adenocarcinoma
• Measurable metastatic disease.
• Age +/> 70
• Progression on standard therapy, not a candidate for further chemotherapy or patient declines other options
• Life expectancy >/= 12 weeks
• Able to understand and willing to sign written informed consent.
• Laboratory requirements:
• Total bili ≤ 1.5 x upper limit or normal
• Alanine aminotransferase & Asparate aminotransferase ≤ 2.5 x upper limit or normal
• Serum creatinine ≤ 1.5 x upper limit or normal
• International normalized ratio/prothrombin time ≤ 1.5 x upper limit or normal
• Platelet count ≥ 100,000, hemoglobin ≥ 9 g/dL
• Absolute neutrophil count ≥ 1,500. Blood transfusion to meet the inclusion criteria not be allowed.
• Glomerular filtration rate ≥ 60 ml/min
• Subjects of childbearing potential must agree to use adequate contraception beginning at the signing informed consent form until at least 3 months after the last dose of study drug.
• Must be able to swallow and retain oral medications

Exclusion Criteria

• Currently receiving other systemic therapy for metastatic colorectal cancer
• Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
• Uncontrolled hypertension despite optimal medical management
• Active or clinically significant cardiac disease.
• Evidence or history of bleeding diathesis or coagulopathy
• Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks.
• Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, deep vein thrombosis or pulmonary embolus within 6 months of informed consent
• History of other active malignancy within past 2 years.
• Patients with phaeochromocytoma
• Known history of human immunodeficiency virus infection or current chronic/active hepatitis B or C infection.
• Ongoing infection > grade 2
• Symptomatic metastatic brain or meningeal tumors
• Presence of non-healing wound, non-healing ulcer, or bone fracture
• Renal failure requiring hemo- or peritoneal dialysis
• Dehydration ≥ grade 1
• Patients with seizure disorder requiring medication
• Persistent proteinuria ≥ grade 3 Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
• Pleural effusion or ascites that causes respiratory compromise, grade 2 dyspnea
• History of organ allograft including corneal transplant
• Known or suspected allergy or hypersensitivity to the study drug
• Any malabsorption condition
• Any condition which makes the subject unsuitable for trial participation
• Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study.