Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma

Exclusion Criteria

• •Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI-CTCAE v4.0\] on repeated measurement) despite optimal medical management.
• •Active or clinically significant cardiac disease including:
• •Congestive heart failure - New York Heart Association (NYHA) \> Class II.
• •Active coronary artery disease.
• •Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
• •Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
• •Evidence or history of bleeding diathesis or coagulopathy.
• •Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
• •Subjects with any previously untreated or concurrent cancer that is distinct in primary site or
• •Recent history of prior cancer except cervical cancer in situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before enrollment are allowed.
• •Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
• •Ongoing infection \> Grade 2 NCI-CTCAE v4.0.
• •Symptomatic metastatic brain or meningeal tumors.
• •Presence of a non-healing wound, non-healing ulcer, or bone fracture.
• •Patients with seizure disorder requiring medication.
• •Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
• •Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.0 Grade 2 dyspnea).
• •History of organ allograft (including corneal transplant).
• •Any malabsorption condition.
• •Women who are pregnant or breast-feeding.
• •Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.