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