Neoplasms

Inclusion Criteria

- Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors who are not candidates for standard therapy or in whom regorafenib or cetuximab is considered a standard treatment. Patients with metastatic colorectal cancer (mCRC) must have a record of K-ras gene mutational analysis available and no K-ras mutation is present.
 - Male or female patients ≥ 18 years of age
 - Women of childbearing potential must have a blood or urine pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment
 - Life expectancy of at least 3 months
 - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment:
 -- Platelet count ≥ 100,000/cubic millimeters (mm3), hemoglobin (Hb) ≥ 8.5 g/dl, leukocyte count > 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,000/mm3
 -- Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Mildly elevated total bilirubin (< 6 mg/dL) is allowed if Gilbert’s syndrome is documented.
 -- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
 -- Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects whose cancer involves their liver). 
 -- Amylase and lipase ≤ 1.5 x ULN
 -- Serum creatinine ≤ 1.5 times ULN and creatinine clearance (CLcr) ≥ 30 mL/min according to the Cockroft-Gault formula
 - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria

- Prior treatment with Regorafenib
 - Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab
 - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
 - Non-healing wound, ulcer, or bone fracture
 - Systemic anticancer therapy within 28 days
 - Patients unable to swallow and retain oral medications