Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy

An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy

This is an open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this study is to provide additional information about the safety profile of Regorafenib.

Inclusion Criteria:

• Male or female subjects >/= 18 years of age
• Life expectancy of at least 3 months
• Histological or cytological documentation of adenocarcinoma of the colon or rectum
• Subjects with metastatic colorectal cancer (Stage IV)
• Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab if KRAS WT (WT: wild-type i.e. no KRAS mutation)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements
• Women of childbearing potential and men must agree to use adequate contraception since signing of the inform consent (IC) form until at least 3 months after the last study drug administration

Exclusion Criteria:

• Prior treatment with regorafenib
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
• Pregnant or breast-feeding subjects
• Congestive heart failure >/= New York Heart Association (NYHA) class 2
• Myocardial infarction less than 6 months before start of study drug
• Ongoing infection > Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
• Renal failure requiring hemo-or peritoneal dialysis