Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases) Obtained within 28 days prior randomization: alkaline phosphatase must be =< 2.5 x ULN for the lab with the following exception: patients with documented liver metastases or bone involvement - alkaline phosphatase must be =< 5 x ULN; and Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases) Serum alkaline phosphatase =< 3 x upper limit of normal (ULN) in absence of liver or bone metastases and =< 5 x ULN in patients with documented bone or liver metastases Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 X ULN (less than or equal to 5 X ULN if participant has liver metastases). If alkaline phosphatase is greater than 3 X ULN (in absence of liver metastases) or greater than 5 X ULN (in presence of liver metastases) AND the participant also is known to have bone metastases, the liver-specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of total alkaline phosphatase Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases) Alkaline phosphatase =< 2.5 x upper limit of normal (ULN) or =< 5 X ULN if bone metastases (mets) are present Alkaline phosphatase ? 3 x ULN or ? 5 x ULN if bone metastasis is present Alkaline phosphatase =< 2.5 x ULN or =< 5 x ULN if judged by the investigator to be related to liver metastases Alkaline phosphatase =< 2.5 x ULN with the following exception: patients with documented liver involvement or bone metastases: alkaline phosphatase =< 5 x ULN. STUDY TREATMENT: Alkaline phosphatase =< 2.5 × ULN within 14 days prior to the first study treatment with the following exception:\r\n* Patients with documented liver involvement or bone metastases: alkaline phosphatase =< 5 ×ULN. Alkaline phosphatase =< 2.5 x ULN; =< 5 x ULN for patients with documented liver involvement or bone metastases. Alkaline phosphatase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ?3 × ULN (in the case of liver metastases ?5 × ULN), unless there are bone metastases, in which case liver-specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase. Alkaline phosphatase =< 2.5 x ULN with the exception that patients with documented liver involvement or bone metastases: alkaline phosphatase =< 5 x ULN Obtained within 14 days prior to the first study treatment (cycle 1, day 1): alkaline phosphatase =< 2.5 x ULN with the following exception: 1) =< 5 x ULN in patients with documented liver metastases =< 7 x ULN in patients with documented bone metastases Alkaline phosphatase must be =< 2.5 x ULN (unless elevated alkaline phosphatase clearly due to skeletal—rather than hepatic—process; eg, normal gamma-glutamyltransferase (GGT), presence of multiple bone metastases, absence of bulky and/or central liver metastases). Patients with Gilbert’s syndrome are allowed if total bilirubin =< 2 x ULN and direct bilirubin is =< ULN Alkaline phosphatase =< 2.5 x ULN with the following exception:\r\n* Patients with documented liver involvement or bone metastases: alkaline phosphatase =< 5 x ULN Alkaline phosphatase =< 2.5 x ULN (obtained within 28 days prior to first study treatment)\r\n* Subjects with documented liver or bone metastases should have alkaline phosphatase =< 5 x ULN Alkaline phosphatase ? 2.5 x ULN within 14 days prior to the first study treatment (cycle 1, day 1) with the following exception:\r\n? Patients with documented liver involvement or bone metastases: alkaline phosphatase ? 5 x ULN Alkaline phosphatase =< 2.5 x ULN unless bone metastases present Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present) Alkaline phosphatase ? 2.5 x ULN (? 5.0 x ULN if bone or liver metastases present) For subjects without extensive bone metastases: alkaline phosphatase levels < 2.5 x ULN REGORAFENIB INCLUSION CRITERIA: Alkaline phosphatase (ALP) =< 2.5 x ULN if no liver metastases are present; =< 5 x ULN if bone or liver metastases are present Alkaline phosphatase < 2.5 upper limit of normal (ULN) (< 10 x ULN in presence of bone metastases) within 14 days of study entry Alkaline phosphatase =< 2.5 x ULN for the laboratory (=< 5 x ULN for patients with cancer involving the liver and/or bone) Alkaline phosphatase =< 3 x ULN (in the case of liver metastases, =< 5 x ULN) Alkaline phosphatase ? 2.5 × ULN (? 5 ± ULN for patients with documented liver involvement or bone metastases) Within 14 days prior to the first study treatment (cycle 1, day 1): Alkaline phosphatase =< 2.5 x ULN with the following exception: Patients with documented bone metastases: alkaline phosphatase =< 5 x ULN. Alkaline phosphatase =< 2.5 x ULN, obtained within 14 days prior to the first study treatment (cycle 1, day 1) with the following exception:\r\n* Patients with documented liver or bone metastases may enroll with alkaline phosphatase =< 5 x ULN Alkaline phosphatase < 2.0 x ULN (if liver or bone disease are present, < 3.0 x ULN) Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases) Alkaline phosphatase (ALP) =< 1.5 x ULN but =< 2.5 x ULN in case of liver metastases or =< 5 x ULN in the case of bone metastasis; in the presence of liver metastases the liver isoenzyme fraction must be measured and liver\r\nisoenzyme fraction (absolute value) must be =< 2 x UNL Alkaline phosphatase =< 2.5 x ULN with the following exception: \r\n* Patients with documented liver involvement or bone metastases: \r\n** Alkaline phosphatase =< 5 x ULN Alkaline phosphatase =< 3.0 x ULN; up to 5 x ULN is acceptable if due to bone metastases in the absence of liver metastases Alkaline phosphatase <3.0 x ULN or ?5.0 x ULN if liver or bone metastases present Alkaline phosphatase <3.0 x ULN or ?5.0 x ULN if liver or bone metastases present Alkaline phosphatase < 2.0 x ULN (if liver or bone metastases are present, < 3.0 x ULN) Within 14 days of enrollment: Alkaline phosphatase =< 2.5 x ULN for the institution\r\n* For patients in the metastatic cohort with documented liver or bone metastases cohort with documented liver or bone metastases: alkaline phosphatase =< 5 x ULN Alkaline phosphatase < 2 x ULN (if known liver or bone disease) Obtained within 14 days prior to the first study treatment (cycle 1, day 1); alkaline phosphatase ? 2.5 x ULN with the following exception:\r\n* Patients with documented liver involvement or bone metastases: alkaline phosphatase ? 5 x ULN Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) less than or equal 3 x ULN (less than or equal 5 x ULN if subject has liver metastases). If alkaline phosphatase is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND the subject also is known to have bone metastases, the liver-specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of total alkaline phosphatase. Alkaline phosphatase (AP) =< 3 x the ULN or =< 5 × the ULN in the presence of known liver metastases For subjects without extensive bone metastases: alkaline phosphatase levels =< 2.5 x ULN For subjects with extensive bone metastases: alkaline phosphatase levels =< 5 x ULN Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases) Alkaline phosphatase =< 2.5 x ULN (obtained within 14 days prior to the first study treatment [course 1, day 1]) with the following exception:\r\n* Patients with documented liver involvement or bone metastases: alkaline phosphatase =< 5 x ULN Serum alkaline phosphatase ? 3x ULN (upper limit of normal)in the absence of liver or bone metastases or ?5 ULN(in patients with documented bone or liver metastases) Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3*ULN unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase. ALT and AST <= 5*ULN if participant has liver metastases. Alkaline phosphatase =< 2.0 x ULN; if bone or liver metastases are present, =< 5 x ULN For patients with known bone metastases, alkaline phosphatase < 5 x ULN is acceptable Obtained within 28 days prior to registration: Alkaline phosphatase =< 2.5 x ULN (subjects with documented liver or bone metastases should have alkaline phosphatase =< 5 x ULN) Alkaline phosphatase < 2.5 × ULN unless hepatic metastases are present, then < 5 × ULN Alkaline phosphatase =< 2.5 x ULN in the absence of known bone metastases or =< 5.0 x ULN in the case of bone metastases Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ?3 × ULN (?5 × ULN if participant has liver metastases). If alkaline phosphatase is >3 × ULN (in absence of liver metastases) or >5 × ULN (in presence of liver metastases) AND the participant also is known to have bone metastases, the liver-specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of total alkaline phosphatase.