Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement) Within 3 weeks prior to study registration: \r\nAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) within 3 weeks prior to study registration Alkaline phosphatase < 2.5 x the ULN or < 5 x the ULN if secondary to liver metastasis Alkaline phosphatase =< 2.5 x ULN (or =< 5 x ULN for subjects with liver metastasis) Alkaline (Alk.) phosphatase =< 3 x ULN unless evidence of the direct liver involvement by lymphoma - then =< 5 x ULN obtained =< 14 days prior to registration Alkaline phosphatase limit =< 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 with liver involvement of their cancer) Alkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) Alkaline phosphatase =< 2.5 times the ULN (=< 5 x ULN for patients with liver involvement) Alkaline phosphatase limit =< 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 with liver or bone involvement of their cancer) FULL STUDY INCLUSION CRITERIA: Alkaline phosphatase (ALP) limit =< 2.5 x ULN (=< 5 x ULN for patients with liver involvement of their cancer) Alkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) Alkaline phosphatase =< 3 x ULN (=< 5 x ULN with liver involvement of their cancer) Alkaline phosphatase =< 3 X ULN unless due to direct lymphoma involvement, and then =< 5 X ULN Alkaline phosphastase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement) Alkaline phosphatase limit =< 2.5 x ULN (=< 5.0 x ULN for subjects with intrahepatic involvement of their cancer) Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement) Alkaline phosphatase levels ? 2.5 × ULN (? 5 × ULN in subjects with liver metastasis) Alkaline (Alk.) phosphatase =< 3 x ULN unless evidence of the direct liver involvement by lymphoma – then =< 5 x ULN alanine transaminase, aspartate aminotransferase and alkaline phosphatase ?3 × ULN or <5 × ULN in cases of liver involvement Alkaline phosphatase limit =< 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 with liver involvement of their cancer) Alkaline phosphatase =< 3 x ULN (=< 5 x ULN if liver or bone involvement) Alkaline phosphatase limit =< 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 patients with liver involvement of their cancer) (obtained =< 7 days prior to randomization) Alkaline phosphatase limit =< 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 with liver involvement of their cancer) Alkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) Alkaline phosphatase =< 2.5 x ULN; unless elevated secondary to lymphoma involvement of the liver Alkaline phosphatase =< 3 x ULN (=< 5 x ULN with liver involvement of their cancer) Alkaline phosphatase limit <2.5 x ULN (<5 x ULN for subjects with liver involvement of their cancer) Alkaline phosphatase levels ? 2.5 × ULN (? 5 × ULN in subjects with liver metastasis) Alkaline phosphatase limit =< 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 with liver or bone involvement of their cancer) Alkaline Phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement) Alkaline phosphatase limit ? 2.5 x ULN (? 5 x ULN for subjects whose cancer involves their liver). Alkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) Alkaline phosphatase =< 3 x ULN, unless evidence of direct liver involvement by lymphoma, then =< 5 x ULN Alkaline phosphatase =< 3 x ULN unless due to direct lymphoma involvement, and then =< 5 x ULN Alkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) Alkaline phosphatase =< 1.5 x the institutional ULN Alkaline phosphatase (ALK Phos) =< 2.5 x institutional ULN Alkaline phosphatase =< 1.5 x IULN within 28 days prior to registration Within 6 weeks prior to randomization: Alkaline phosphatase must be =< 2.5 x ULN for the lab Alkaline phosphatase =< 2.5 x ULN (CTCAE v 3.0 grade 0-1) Alkaline phosphatase =< 3 x ULN Alkaline phosphatase =< 1.5 x institutional ULN, within 21 days prior to registration Alkaline phosphatase =< 2 x IULN Patients must have alkaline phosphatase =< 2.5 x IULN within 14 days prior to registration Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1) Alkaline phosphatase =< 3X the institutional ULN Alkaline phosphatase ? 2.5 x ULN, unless the elevated alkaline phosphatase is due to bone metastasis. Alkaline phosphatase ? 2.5 × ULN; Alkaline phosphatase =< 2 × ULN (=< 5 × ULN if considered due to tumor) Alkaline phosphatase < 5 times ULN AST and/or ALT > 1.5 x ULN with concomitant alkaline phosphatase > 2.5 x ULN Serum alkaline phosphatase =< 5 x institutional ULN Alkaline phosphatase =< 3 × ULN Alkaline phosphatase > 3 ULN Alkaline phosphatase should be less than or equal to 2.5 x ULN (CTCAE v4.0, grade 1) Have an alanine aminotransferase (ALT) ?3.0 × ULN. (Note: There are no specific requirements for AST or alkaline phosphatase.) alkaline phosphatase must be ? 2.5 x ULN for the lab; and Alkaline phosphatase =< 2.5 x ULN; (=< 5 x ULN in case of bone metastasis) Alkaline phosphatase =< 2.5 x ULN, within 14 days prior to registration Alkaline phosphatase =< 2.5 x ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) with alkaline phosphatase =< 2.5 x ULN OR AST and ALT =< 1.5 x ULN, with alkaline phosphatase > 2.5 x ULN ARM 2 - A: AST/ALT/alkaline phosphatase: =< 5 x ULN Alkaline phosphatase =< 3 x ULN =< 28 days prior to registration Alkaline phosphatase up to 2.5 x ULN. COHORT B ONLY: Obtained =< 14 days prior to registration: alkaline phosphatase =< 750 U/L Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase less than 1.5 times ULN (grade 1) Alkaline phosphatase =< 2.5 x ULN ALT or aspartate AST > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN AST and ALT =< 1.5 x ULN, with alkaline phosphatase > 2.5 x ULN Alkaline phosphatase < 2.5 × ULN Serum alkaline phosphatase =< 5 X ULN Obtained =< 14 days prior to registration: Alkaline phosphatase =< 3 x ULN Alkaline phosphatase =< 2.5 x ULN for the institution within 14 days of study registration Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4.03 grade 1) Alkaline phosphatase =< 5 x ULN must be met during screening (within 21 days) and also prior to study drug administration on cycle 1 day 1 Within 14 days prior to registration: Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase < 4 x ULN. Alkaline phosphatase (alk phos) < 2.5 X ULN Alkaline phosphatase =< 2.5 X ULN Alkaline (Alk) phosphatase < 2.5 x ULN Hepatic impairment, defined as alkaline phosphatase =< 2 x institutional ULN, within 21 days of initiation of protocol therapy Hepatic impairment, defined as alkaline phosphatase > 2 x institutional ULN, within 21 days of initiation of protocol therapy Alkaline phosphatase =< 3 x ULN Determined within 3 weeks of treatment initiation: Alkaline phosphatase < 5 x ULN Alkaline phosphatase =< 2.5 x ULN prior to biopsy Obtained =< 7 days prior to registration: Alkaline phosphatase < 5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase < 3 x ULN Alkaline phosphatase > 2.5 x ULN Alkaline phosphatase =< to 2.5 x ULN Alkaline phosphatase < 5 x ULN obtained =< 7 days prior to registration Alkaline phosphatase =< 2.5 x institutional ULN obtained within 14 days of first treatment Alkaline phosphatase =< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase (Alk phos) =< 5 X ULN Alkaline Phosphatase less than 2.5 x ULN (CTCAE Grade 1) Alkaline phosphatase (liver fraction) =< 2.5 X ULN; if AST or ALT is > 2.5 X ULN, then liver fraction of alkaline phosphatase should be =< 2.5 X ULN Alkaline phosphatase > 2.5 x ULN Alkaline phosphatase (AP) ? 2.5 x ULN, unless considered due to organ leukemic involvement; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) with alkaline phosphatase =< 2.5 x ULN OR AST and ALT =< 1.5 x ULN, with alkaline phosphatase > 2.5 x ULN Alkaline phosphatase (alk phos) < 2.6 x ULN Alkaline phosphatase =< 1.5 x ULN, obtained =< 14 days prior to registration Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase < 5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 ULN Alkaline phosphatase > 2.5 x ULN Alkaline phosphatase < 5 x ULN Alkaline phosphatase < 2.5 x ULN Serum alkaline phosphatase =< 5 x ULN Alkaline phosphatase < 5 x ULN Alkaline phosphatase =< 2 x ULN or considered not clinically significant Obtained =< 14 days prior to registration: Alkaline phosphatase =< 750 U/L Alkaline phosphatase ?2.0×ULN. Alkaline phosphatase ?5 x ULN ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Alkaline phosphatase < 2 x ULN Alkaline phosphatase < 2.5 X ULN Alkaline phosphatase < 252 u/L Alkaline phosphatase < 2.0 x ULN Alkaline phosphatase must be =< 3 x ULN for the lab within 28 days before randomization Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase (ALK Phos) < 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN; if liver involvement, alkaline phosphatase =< 5.0 x ULN Alkaline phosphatase =< 2.5 x ULN for the institution Alkaline phosphatase must be =< 2.5 x ULN for the lab Alkaline phosphatase and AST may not both be > the ULN; for example, if the alkaline phosphatase is > the ULN but =< 2.5 x ULN, the AST must be =< the ULN; if the AST is > the ULN but =< 1.5 x ULN, the alkaline phosphatase must be =< ULN; Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 1.5 x ULN; if both were performed, the AST must be =< 1.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN (CTEP CTCAE version 4.0, grade 1) Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase >= 2 x institutional ULN, within 21 days of initiation of protocol therapy Alkaline phosphatase =< 2.5 x upper limit of normal (ULN); patients with hepatic and/or bone metastases: alkaline phosphatase =< 5 x ULN Alkaline phosphatase >= 2 x ULN Alkaline phosphatase =< 2 x IULN be obtained within 42 days prior to registration Alkaline phosphatase =< 1.5 x ULN (institutional) Alkaline phosphatase ? 5 x ULN Alkaline phosphatase =< 2.5 x ULN for the institution Alkaline phosphatase less than or equal to 2.5 x ULN Alkaline phosphatase greater than 2.5 x ULN (CTCAE v4.0 grade 1) (if known hepatic metastases alkaline phosphatase may be =< 5 x ULN) Alkaline phosphatase* less than or equal to 2.5 x ULN Alkaline phosphatase =< 1.5 UNL alkaline phosphatase must be less than or equal to 2 x ULN; and Alkaline phosphatase < 5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase ?2.0×ULN Alkaline phosphatase limit ? 2.5 x ULN Alkaline phosphatase less than or equal to 3 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN Alkaline phosphatase < or equal to 4 x ULN if not related to leukemic disease Alkaline phosphatase ? 2.5 x ULN Alkaline phosphatase within 5 times ULN Alkaline phosphatase ? 5X ULN Alkaline phosphatase =< 2.5 x ULN Alkaline (Alk.) phosphatase =< 3 x ULN Alkaline phosphatase: ? 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN obtained =< 14 days prior to registration Alkaline phosphatase > 3 x institutional ULN, within 21 days of initiation of protocol therapy Alkaline phosphatase =< 3 x ULN Alkaline phosphatase (AP) =< 2.0 x ULN Alkaline phosphatase < 2 X institutional ULN Alkaline phosphatase < 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 5 x ULN Alkaline phosphatase =< 5.0 x ULN Alkaline phosphatase =< 1.5 x IULN Alkaline phosphatase < 5 x ULN Alkaline phosphatase >= 2.5 times ULN Alkaline phosphatase > 3 x ULN Alkaline phosphatase > 2 x institutional ULN Alkaline phosphatase =< 2.5 x ULN Serum alkaline phosphatase should be =< 1.5 x institutional ULN Alkaline phosphatase (Alk Phos) =< 2.5 x ULN Alkaline (Alk) phosphatase < 2.5 x ULN Obtained =< 7 days prior to registration: Alkaline phosphatase =< 3 x ULN Alkaline phosphatase >= 3 x ULN Alkaline phosphatase ? 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 X ULN Alkaline phosphatase =< 2.5 x ULN for the institution Alkaline phosphatase =< 2.5 x ULN, CTCAE grade 1 Alkaline phosphatase < 2.5 x ULN Alkaline phosphatase no greater than 1.5 times ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN Alkaline phosphatase values within the institutional ULN Alkaline phosphatase =< 2.5 X ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase < 2.5 x ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and alkaline phosphatase must be within the eligible; in determining eligibility, the more abnormal of the two values (AST or ALT) should be used; patients with alkaline phosphatase elevation secondary to the bony metastases rather than liver dysfunction may proceed with treatment on protocol after discussion with the principal investigator Alkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT =< ULN eligible Alkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT =< ULN eligible Alkaline phosphatase > 5 x ULN and AST or ALT =< ULN ineligible Alkaline phosphatase =< ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN eligible Alkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN eligible Alkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN ineligible Alkaline phosphatase > 5 x ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN ineligible Alkaline phosphatase =< ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN eligible Alkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN ineligible Alkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN ineligible Alkaline phosphatase > 5 x ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN ineligible Alkaline phosphatase =< ULN and AST or ALT > 5 x ULN ineligible Alkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT > 5 x ULN ineligible Alkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT > 5 x ULN ineligible Alkaline phosphatase > 5 x ULN and AST or ALT > 5 x ULN ineligible Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4.0 grade 1) Alkaline phosphatase < 3 x ULN Alkaline phosphatase =< 2 X ULN Alkaline phosphatase =< 2.5 times ULN Alkaline phosphatase ? 2.5 times the ULN Alkaline phosphatase =< 2.5 x ULN for the institution Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x IUNL Alkaline phosphatase (AP) must be within the range allowing for eligibility, as follows:\r\n* =< ULN\r\n* =< 2.5 x ULN\r\n* =< 5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 3.0 x ULN; if liver involvement, alkaline phosphatase =< 5.0 x ULN Alkaline phosphatase must be =< 2.5 x ULN for the lab Alkaline phosphatase and AST/ALT may not both be > the ULN; for example, if the alkaline phosphatase is > the ULN but =< 2.5 x ULN, then the AST/ALT must be =< the ULN; if the AST/ALT is > the ULN but =< 1.5 x ULN, then the alkaline phosphatase must be =< ULN Patients with AST/ALT or alkaline phosphatase > ULN must have liver imaging that does not demonstrate metastatic disease Alkaline phosphatase above 2.5X the ULN Alkaline phosphatase =< 5 x UNL Alkaline phosphatase of =< 2 ULN The subject has aspartate aminotransferase and/or alanine aminotransferase > 1.5 × ULN, with concomitant alkaline phosphatase > 2.5 × ULN. Alkaline phosphatase limit =< 2.5 x ULN Alkaline phosphatase (Alk phos) =< 3.0 x ULN Alkaline phosphatase =< to 2.5 x ULN Alkaline phosphatase =< 5 x institutional ULN obtained =< 7 days prior to registration Part 2 only: plasma total bilirubin <= ULN; ALT and/or AST <= 1.5 X ULN concomitant with alkaline phosphatase <= 2.5 X ULN. Part 2 only: Patients with plasma total bilirubin > ULN; ALT and/or AST > 1.5 X ULN concomitant with alkaline phosphatase > 2.5 X ULN. Alkaline phosphatase =< 2.5 × ULN (patients with hepatic and/or bone metastases: alkaline phosphatase =< 5 × ULN) Liver: hepatomegaly on physical exam with elevated alkaline phosphatase > 1.5 x ULN Alkaline phosphatase ? 5 x ULN Alkaline phosphatase < 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN; except for patients with hepatic and/or bone metastases: alkaline phosphatase =< 5 x ULN Alkaline phosphatase < 2 x ULN (< 5 x ULN in subjects whom the PI and sponsor agree that clinical data suggest extrahepatic source of elevation) Alkaline phosphatase (AP) =/< 2.5 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1) Alkaline phosphatase =< 1.5 x ULN Alkaline phosphate =< 2.5 x ULN (within four weeks prior to the study) Alkaline phosphatase < 2 times ULN, unless arising from bone Alkaline phosphatase =< 5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase limit =< 2.5 x ULN Alkaline phosphatase < 2 times ULN, unless arising from bone Alkaline phosphatase less than or equal to 2.5 x ULN Alkaline phosphatase limit =< 2.5 x ULN Serum alkaline phosphatase < 2 x ULN, or considered not clinically significant by the study doctor or designee Alkaline phosphate > 1.5 x ULN Patients with plasma alkaline phosphatase greater than 190 IU/dL Alkaline phosphatase =< 2.5 x ULN Serum alkaline phosphatase level >= 300 IU/L. Alkaline phosphatase ? 2.5 x ULN Alkaline phosphatase < 5 x ULN Alkaline phosphatase < 4 x ULN Alkaline phosphatase =< 1.5 x ULN Alkaline phosphatase < 2 x ULN Alkaline phosphatase < 2 x ULN Alkaline phosphatase =< 1.5 x institutional ULN Alkaline phosphatase > 2.5 x ULN Alkaline phosphatase < 2.5 x ULN Alkaline phosphatase =< 2.5 time ULN Alkaline phosphatase =< 2 X ULN Alkaline phosphatase =< 2.5 x IULN Alkaline phosphatase (ALK phos) within 2 x ULN Alkaline phosphatase =< 2.5 x IULN Alkaline phosphatase (AP) =< 3 X ULN, obtained within 14 days prior to PET scan Alkaline phosphatase < 3 x ULN Alkaline phosphatase =< 5 x ULN Alkaline phosphatase < 2.5 x ULN Alkaline phosphatase =< 190 IU/dL Patients with plasma alkaline phosphatase greater than 190 IU/dL Alkaline phosphatase ? 2.5 x ULN Gamma-glutamyl transferase (GGT) alkaline phosphatase ? 2.5 × ULN. Gamma-glutamyl transpeptidase (GGT): 0-45 U/L Gamma-glutamyltransferase =< 2.5 x ULN Gamma-glutamyl transpeptidase (GGT) must be =< 2.5 x institutional upper limit of normal (grade 1 or less per CTCAE 4) For LY3300054 + abemaciclib only: No participants with liver metastases. Participants must have normal aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, gamma-glutamyl transferase (GGT) and alkaline phosphatase (AP). Alkaline phosphatase (ALP) =< 3 x ULN; if ALP is > 3 x ULN, gamma glutamyl transpeptidase (GGT) must be checked and be =< 3 x ULN (must be within 7 days of MLA) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), creatine phosphokinase (CPK), lactate dehydrogenase (LDH), alkaline phosphatase (Alk phos) =< 2.5 X the ULN Gamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), and alkaline phosphatase =< 2.5 x institutional ULN Gamma-glutamyl transpeptidase (GGT) > 2.5 x ULN if alkaline phosphatase > 2.5 x ULN obtained < 2 weeks prior to study enrollment Gamma-glutamyl transferase (GGT) > 2.5 x ULN IF alkaline phosphatase > 2.5 x ULN Gamma glutamyl transpeptidase (GGT) > 2.5 x ULN IF alkaline phosphatase > 2.5 x ULN Gamma-glutamyl transpeptidase (GGT) less than 4.0 times below or above the upper or lower limit range Gamma-Glutamyl Transpeptidase (GGT) > 2.5 x ULN IF alkaline phosphatase > 2.5 x ULN Gamma-glutamyltransferase (GGT) > 2.5 x ULN Gamma glutamyl transferase (GGT) > 2.5 x ULN IF alkaline phosphatase > 2.5 x ULN Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN) AST (SGOT), ALT (SGPT) and Alkaline phosphatase 2.5 times upper limit of normal (if liver metastases are present, then 5 x ULN is allowed) Within 30 days prior to enrollment: Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN) Alkaline phosphatase =< 4 times the upper limit of normal (unless clinically considered to be related to liver involvement with leukemia) Alkaline phosphatase =< 2.5 times the upper limit of normal Alkaline phosphatase (Alk Phos) greater than 2.5 times the upper limit of normal Alkaline phosphatase =< 2 times upper limit normal Serum alkaline phosphatase less than 2.5 times the upper limits of normal Alkaline phosphatase =< 3 times the upper limit of normal Alkaline phosphatase < 2.5 times the upper limit of normal Alkaline phosphatase < 5 times the upper limit of normal Alkaline phosphatase < 2.5 times normal Serum alkaline phosphatase less than 2.5 times the upper limits of normal within 7 days prior to starting treatment in the absence of liver metastasis; in the presence of liver metastasis serum alkaline phosphatase less than or equal to 5.0 times the upper limits of normal within 7 days prior to starting treatment Alkaline phosphatase < 4 times the upper limit of institutional normal Alkaline phosphatase must be no more than 2.5 times upper limit of normal unless due to disease involvement of the liver Alkaline phosphatase < 5 times upper limit of normal Performed within 14 days prior to study: Alkaline phosphatase < 3 times the upper limits of the institutional normal Alkaline phosphatase < 3 times upper limit of institutional normal Serum alkaline phosphatase < 3 times the upper limit of normal (ULN), unless due to liver or bone involvement by HL; under these circumstances, serum alkaline phosphatase must be < 5 x ULN Alkaline phosphatase within 3 times the upper limits of normal Alkaline phosphatase =< 3 times the institutional upper limit of normal Alkaline phosphatase < 2.5 times institutional upper normal limit (unless due to disease involvement of the liver or bone marrow) Alkaline phosphatase < 3 times normal Patient has poor liver function (> 2.5 times normal of alkaline phosphatase [Alk phos]) suggestive of cirrhosis or steatohepatitis Alkaline phosphatase =< 2.5 times upper limit of normal (unless due to disease involvement of the liver or bone marrow) Alkaline phosphatase > 2.5 times upper normal limit (unless due to chronic GVHD) Alkaline phosphatase =< 2.5 times upper limit of normal Alkaline phosphatase less than 10 times the upper limit of normal (unless due to active myositis) Alkaline phosphatase < 3 times the upper limit of laboratory normal Alkaline phosphatase =< 3 times upper limit of laboratory normal Alkaline phosphatase =< 5.0 times the upper limit of normal unless hepatic dysfunction is related to liver involvement with disease Alkaline phosphatase < 2.5 times the upper limit of normal; in patients with liver metastasis, liver function tests should be < 5 times the upper limit of normal Alkaline phosphatase (hepatic) > 3 times the upper normal limit Serum alkaline phosphatase less than 2.5 times the upper limits of normal Alkaline phosphatase (hepatic) > 3 times the upper normal limit Alk phosphatase =< 3 times institutional upper limit of normal Alkaline phosphatase < 3 times the upper limit of normal (alkaline phosphatase and aspartate aminotransferase [AST] cannot both exceed the upper limit of normal) AST < 3 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal) Alkaline phosphatase (ALP) must be < 2 times the upper limit of normal Alkaline phosphatase (ALK phos) less than 4.0 times below or above the upper or lower limit range Alkaline phosphatase (ALK phos) less than 4.0 times below or above the upper or lower limit range Alkaline phosphatase =< 2 times the upper limit of normal Alkaline phosphatase (ALP) =< 2.5 x ULN measured within 28 days prior to randomization Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the ULN and alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 X ULN (in the case of liver metastases less than or equal to 5 X ULN). In case ALP is greater than 3 X ULN (in the absence of liver metastases) or greater than 5 X ULN (in the presence of liver metastases) AND the participant also is known to have bone metastases, the liver specific ALP must be separated from the total and used to assess the liver function instead of the total ALP Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ?3× the ULN (in the case of liver metastases ?5× the ULN). Participants with bone metastases with ALP values greater than 3 times can be included. Alkaline phosphatase (ALP) =< 3.0 x ULN Alkaline phosphatase (ALP) =< 5.0 x ULN, at the screening visit Alkaline phosphatase (ALP) ? 2.5 × ULN (? 5 × ULN if disease-related/in the case of liver metastases). Patients with isolated elevations in alkaline phosphatase (ALP) < 5 x ULN in the presence of bony disease are not excluded from participating in the study Serum alkaline phosphatase (ALP) > 2 x ULN Alkaline phosphatase (ALP) =< 2.5 x ULN or =< 5.0 x ULN for patients with bone metastases Serum alkaline phosphatase (ALP) =< UNL or =< 2.5 x upper limit of normal (ULN) in case of liver and bone metastases Alkaline phosphatase (ALP) > or = 5 x upper limit of normal (ULN). Alkaline phosphatase (ALP) =< 5.0 x ULN Within 14 days prior to the first study treatment (cycle 1, day 1): Alkaline phosphatase (ALP) =< 2.0 x ULN with the following exception:\r\n* Patients with documented liver involvement or bone metastases: ALP =< 5 x ULN Total bilirubin and alkaline phosphatase (ALP) =< 2 x ULN or =< 3 x ULN for Gilbert's disease Alkaline phosphatase (ALP) < 2.5 x ULN Alkaline phosphatase (ALP) =< 2.5 x ULN for the laboratory\r\n* Note: If ALP is > 1.5 x ULN, imaging to rule out bone and liver metastasis is required Alkaline phosphatase =< 2.5 x ULN with the following exception; alkaline phosphatase (ALP) =< 5 x ULN in patients with bone metastases Alkaline phosphatase (ALP) =< 2.5 x ULN Alkaline phosphatase (ALP) < 2.5 x ULN (3 x ULN for subjects on chronic anticonvulsive therapies). Alkaline phosphatase (ALP) =< 5.0 x ULN Alkaline phosphatase (Alp) =< 2.5 x upper limit of normal (ULN) Alkaline phosphatase (ALP) =< 2 x ULN CAPMATINIB INCLUSION CRITERIA: Alkaline phosphatase (ALP) =< 5 x ULN CERITINIB INCLUSION CRITERIA: Alkaline phosphatase (ALP) =< 5 x ULN PHASE I: Alkaline phosphatase (ALP) < 2.5 x ULN Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) or alkaline phosphatase (ALP) > 2.5 ULN without hepatic metastases or ALT, AST or ALP > 5 ULN with hepatic metastases Alkaline phosphatase (ALP) =< 5.0 x ULN Alkaline phosphatase (ALP) =< 3 x ULN; if ALP is > 3 x ULN, gamma glutamyltransferase (GGT) must be checked and be =< 3 x ULN (must be within 7 days of MLA) Alkaline phosphatase (ALP) =< 5.0 x ULN Alkaline phosphatase (ALP) < 5 x upper limit of normal Alkaline phosphatase (ALP) < 5 x normal Alkaline phosphatase (ALP) levels > 2.5 × ULN. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and Alkaline Phosphatase (ALP) must be within the range allowing for eligibility: ALP normal AND AST or ALT =< 5 x ULN; ALP =< 3.5 x ULN AND AST or ALT =< 1.5 x ULN; OR ALP =< 5 x ULN AND ALT or AST =< ULN Within 14 days prior to first dose of study drug treatment: Alkaline phosphatase (ALP) =< 3 x ULN with the following exceptions:\r\n* Patients with documented liver or bone metastases: ALP =< 5 x ULN Alkaline phosphatase (ALP) < 3 x ULN DOSE ESCALATION COHORT: Alkaline phosphatase (ALP) ? 2.5 X ULN Alkaline phosphatase (ALP) > 250 U/L AST(SGOT), ALT(SGPT), or alkaline phosphatase (ALP) ? 2.5 x ULN. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ? 3 x ULN (? 5 x ULN if participant has liver metastases). If ALP is > 3 x ULN (in the absence of liver metastases) or > 5 x ULN (in the presence of liver metastases) AND participants are also known to have bone metastases, the liver-specific ALP must be separated from the total and used to assess the liver function instead of the total ALP. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULRR or alkaline phosphatase (ALP) > 2.5 x ULRR Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 2.5 x upper limit of normal (ULN), obtained within 14 days prior to initiation of study treatment, with the following exceptions: patients with documented liver metastases: AST and ALT =< 5 x ULN; patients with documented liver or bone metastases: alkaline phosphatase (ALP) =< 5 x ULN Alkaline phosphatase (ALP) ? 3.0 × ULN (< 5 × ULN if isolated ALP increase, i.e., without ALT/AST or bilirubin increase). Alkaline phosphatase (ALP), 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 ALP is greater than 3 X ULN (in the absence of liver metastases) or greater than 5 X ULN (in the presence of liver metastases) AND the participant also is known to have bone metastases, the liver-specific ALP must be separated from the total and used to assess the liver function instead of total ALP. Alkaline phosphatase (ALP) >5 xULN Alkaline phosphatase (ALP) =< 2.5 x ULN unless considered tumor-related Alkaline phosphatase (ALP) =< 2.5 x ULN unless considered tumor related Alkaline phosphatase (ALP) =< 2.5 x ULN unless considered tumor related Alkaline phosphatase (ALP) =< 2.5 x ULN (within 7 days prior to registration) Alkaline phosphatase (ALP) limit < 2.5 x ULN or =< 5.0 x ULN if liver metastases are present Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ?2.5 × ULN. For subjects with bone metastases and/or suspected disease-related liver or biliary involvement, ALP must be ?5 × ULN. If bone metastases are present and liver function is otherwise considered adequate by the Investigator then elevated alkaline phosphatase (ALP) will not exclude the patient. Alkaline phosphatase (Alp) =< 2.5 x ULN Alkaline phosphatase (ALP) =< 2.5 x ULN unless considered tumor related Alkaline phosphatase (Alp) =< 2.5 x ULN Alkaline phosphatase (ALP) ?5 × ULN (except for subjects with hepatomegaly and isozymes specific to liver, rather than bone) Alkaline phosphatase (ALP) < 3 x UNL Alkaline phosphatase (ALP) < 5 x upper limit of normal Alkaline phosphatase (ALP) =< 2.5 x ULN, with the following exceptions: patients with documented liver or bone metastases: ALP =< 5 x ULN Alkaline phosphatase (ALP) < 5 x ULN ALP ? 3 x ULN or ? 5 x ULN if bone metastasis is present Alkaline phosphatase =< 3 ULN; if total ALP is > 3 x ULN (in the absence of liver metastasis) or > 5 x ULN in subjects with liver metastasis AND the subject is known to have bone metastases, then liver ALP iso-enzyme should be used to assess liver function rather than total ALP Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times ULN. For total ALP greater than 3 times ULN, the ALP liver isoenzyme must be less than or equal to 3 times ULN. Patients enrolled without hepatic dysfunction must have laboratory test results for total bilirubin of less than the ULN, alkaline phosphatase (ALP) <=1.5x the ULN, and AST and ALT of <=the ULN. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP): all three < 2.5 x ULRR, or < 5 x ULRR if judged by the investigator to be related to liver metastases Bilirubin and Alkaline phosphatase (ALP) =< 2 x ULN Alkaline phosphatase (ALP) =< 5.0 x ULN Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ?3 × ULN (?5 × ULN if participant has liver metastases). If ALP is >3 × ULN (in the absence of liver metastases) or >5 × ULN (in the presence of liver metastases) AND participants are also known to have bone metastases, the liver-specific ALP must be separated from the total and used to assess the liver function instead of the total ALP. Alkaline phosphatase (ALP) > 2 x ULRR, or > 4 x ULRR if judged by the investigator to be related to liver metastases Alkaline phosphatase (ALP) > 2.5 x ULRR Individuals with alkaline phosphatase (ALP) > 2.5 x normal upper limit any time during the previous 2 months Alkaline phosphate =< 3 x normal Alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry Alkaline phosphatase =< 2.5 x institutional upper limit of normal Alkaline phosphatase < 2.5 x upper limit of normal if no documented liver disease or < 6 x upper limit of normal if documented liver or bone disease Alkaline phosphatase =< 5 x upper limit of normal Alkaline phosphatase =< 2.5 X institutional upper limit of normal, determined within 14 days of registration Alkaline phosphatase =< 5 x upper limit normal (ULN) PART I: Alkaline phosphatase (Alk PO4) =< 3 x the upper limits of normal (except for patients with documented metastatic disease to bone and/or liver) Bilirubin <= 1.5 mg/dL; ALT, AST, and alkaline phosphatase <= 3.0x the upper limit of normal Alkaline phosphatase =< 2 x upper limit of normal Alkaline phosphatase =< 2.5 x upper limit of reference range (or =< 5 x upper limit of reference range if considered to be related to liver or bone metastases by the principal investigator [PI]) Alkaline phosphatase < 3 x institutional upper limit of normal (ULN) Alkaline phosphatase >= 3 x institutional upper limit of normal (ULN) Alkaline phosphatase =< 3 x upper limit of normal Alkaline phosphatase =< 2.5 x institutional upper limit of normal Alkaline phosphatase =< 3 X the upper limit of normal (ULN) Alkaline phosphatase =< 3 x institutional upper limit of normal within 30 days of registration Alkaline phosphatase < 5 x upper limit of normal Bilirubin >2.0; alkaline phosphatase >5x upper limit of normal (ULN); ALT/AST >2x ULN. Alkaline phosphatase =< 2.5 institutional upper limit of normal of =< 5 x ULN if liver metastases are present Alkaline phosphatase =< 2.5 x normal prior to biopsy Alkaline phosphatase > 5 X upper limits of normal (ULN) Alkaline phosphatase levels =< 2.5 x upper limit of normal (ULN) Alkaline phosphatase =< 2.5 x upper limit (UL) Alkaline phosphatase < 5 x upper limit of normal (ULN) Alkaline phosphatase =< 2 x upper limit of normal, unless proven to be due to disease involvement ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Alkaline phosphatase (alk phos) =< 5 X upper level of normal Alkaline phosphatase < 2.5 x upper limit of normal Alkaline phosphatase < 3 x upper limit of normal (ULN) Alkaline phosphatase < 2 x upper limit of normal Alkaline phosphatase < 2 upper limit of normal (ULN) Alkaline phosphatase less than 1.5 x upper limit of normal Alkaline (Alk) phosphatase (Phos) =< 5 x upper limit of normal Alkaline phosphatase must be =< 4 x the institutional upper limit of normal (ULN) Alkaline phosphatase =< 5 x the upper limit of normal; serum bilirubin > 2.0 is acceptable in the setting of known Gilbert’s syndrome Bilirubin, aspartate aminotransferase (AST), alkaline phosphatase (ALK) =< 2 x normal Aspartate aminotransferase (AST) and alkaline phosphatase < 5 x upper limit of normal AST and alkaline phosphatase < 5 x upper limit of normal Alkaline phosphatase level =< upper limit of normal (ULN) Alkaline phosphatase (ALK Phos) =< 2.5 X institutional upper limit of normal Alkaline phosphatase =< 4 x institutional upper limit of normal (IULN) Alkaline (Alk) phosphatase =< 5 x upper limit of normal Alkaline phosphatase > 3 x normal Within 14 days of registration: Alkaline phosphatase =< 5 x upper limit of normal Alkaline phosphatase =< 2.5 x institutional upper limit of normal Alkaline phosphatase =< 3 X institutional upper limit of normal Alkaline phosphatase =< 3 X institutional upper limit of normal No history of severe prior or ongoing chronic liver disease; alkaline phosphatase < 5 x upper limit of normal Alkaline phosphatase =< 2.5 x upper limit of normal Alkaline phosphatase =< 3 x institutional normal Alkaline phosphatase =< 5 X upper limit of normal (ULN) Alkaline phosphatase < 2 x upper limit of normal, or considered not clinically significant by the study doctor or designee Alkaline phosphatase < 5 x upper limit normal (ULN) Within 14 days of registration: Alkaline phosphatase =< 2.5 × institutional upper limit of normal Alkaline phosphatase =< 3 X the upper limit of normal (ULN) Alkaline phosphates must be =< 2.5 X the upper limit of normal Alkaline phosphatase (AP) =< 3 x institutional upper limit of normal Alkaline phosphatase =< 2.5 x upper limit of normal (ULN) Alkaline phosphatase =< 2.5 x institutional upper limit normal Alkaline phosphatase =< 2.5 x normal prior to biopsy Alkaline phosphatase ? 2.5 x upper limit of normal (ULN) Alkaline phosphatase =< 2.5 x normal limits Alkaline phosphatase =< upper limit of normal (ULN) and AST or ALT =< ULN eligible Alkaline phosphatase less than or equal to 2.5 x upper limit of normal, CTCAE v 4.0 grade 1 Alkaline phosphatase =< 2.5 x upper limit of normal (ULN) Alkaline phosphatase =< 2.5 X upper limit of normal Alkaline phosphatase =< 1.5 x upper limit of normal Alkaline phosphatase =< 2.5 x upper limit of normal (ULN) Alkaline phosphatase =< 2 x upper limit of normal Alkaline phosphatase > 2 x upper limits of normal (ULN) Alkaline phosphatase =< 2.5 X upper limit of normal Alkaline phosphatase < 2 X upper limit of normal Alkaline phosphatase =< 2.5 x upper limit of normal (ULN) Alkaline phosphatase < 3 x upper limit of normal Alkaline phosphatase < 2.5 X institutional upper limit of normal Alkaline phosphatase =< 5x upper limit of normal Alkaline phosphatase =< 1.5 x upper limit of normal (ULN). Obtained =< 30 days prior to registration: Alkaline phosphatase =< 3 x the institutional upper limit of normal Alkaline phosphatase =< 2.5 x the upper normal limit Alkaline phosphatase =< 2.5 X upper limit of normal; in patients with bone metastasis and no evidence of liver metastasis and bilirubin =< upper limit of normal an alkaline phosphatase =< 5 ULN will be allowed Alkaline phosphatase =< 2.5 x upper limit of normal Alkaline phosphatase < 5 x upper limit of normal Alkaline phosphatase =< 1.5 x institutional upper limit of normal (ULN) Alkaline phosphatase (ALK) =< 1.5 x upper limit of normal (ULN) Liver alkaline phosphatase =< 3 x upper limit of normal Alkaline phosphatase < 2.5 x the upper limit of normal Alkaline phosphatase =< 1.5 x upper limit of institutional normal Alkaline phosphatase =< 1.5 x institutional upper limit of normal Alkaline phosphatase must be less than 4 x upper limit of normal Alkaline phosphatase =< 2.5 x upper limits of normal if no liver metastases present; alkaline phosphatase =< 5 x upper limits of normal if liver metastases present Alkaline phosphatase within normal limits Alkaline phosphatase (Alk phos) =< 2.5 X institutional upper limit of normal 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. Alkaline phosphatase =< 2.5 x IULN, unless bone metastasis is present in the absence of liver metastasis Aspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 x ULN for the institution, alkaline phosphatase ? 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis Patients with any elevated alkaline phosphatase due to bone metastasis can be enrolled Adequate liver function as demonstrated by: Total bilirubin of ?1.5 mg/dL or ?2.0 mg/dL for subjects with liver metastasis, Alanine aminotransferase (ALT) ?3 x upper limit of normal (ULN) or ?5 x ULN if liver metastasis is present, Alkaline phosphatase ?3 x ULN or ?5 x ULN if bone or liver metastasis is present, Gamma-glutamyl transferase (GGT) <10 x ULN Alkaline phosphatase < 2.5 x upper limit of normal, unless bone metastasis is present (< 5 x upper limit of normal) in the absence of liver metastasis Alkaline phosphatase =< 2.5 X ULN, unless bone metastasis is present (< 5 X ULN) in the absence of liver metastasis Alkaline phosphatase > 2.5 x the ULN, there is no upper limit if bone metastasis is present in the absence of liver metastasis Alkaline phosphatase =< 2.5 x ULN, unless bone metastasis is present in the absence of liver metastasis Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis Obtained within 28 days prior to registration: Alkaline phosphatase =< 2.5 x upper limit of normal, unless bone or liver metastasis is present (=< 5 x upper limit of normal) Alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis Alkaline phosphatase =< 2.5 times the upper limit of normal in the absence of liver metastasis; alkaline phosphatase < 5.0 times ULN in the presence of liver metastasis Alkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is present in the absence of liver metastasis Alkaline phosphatase ?2.0 x ULN or ?5 x ULN in case of bone metastasis and/or hepatic metastasis Alkaline phosphatase =< 2.5 times the upper limit of normal, unless bone metastasis is present in the absence of liver metastasis Alkaline phosphatase =< 2.5 x ULN; if bone metastasis is present in the absence of liver metastasis then =< 5 x ULN Alkaline phosphatase < 2.5 x institutional upper limit of normal (in subjects with no liver metastasis and < 5.0 upper limit of normal [ULN] in subjects with liver metastasis) Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis in present in the absence of liver metastasis Alkaline phosphatase =< 2.5 X upper limit of normal in the absence of liver or bone metastasis, or =< 5.0 x upper limit of normal range if bone or liver metastases Alkaline phosphatase =< 2.5 X institutional upper limit of normal, unless bone metastasis is present in the absence of liver metastasis Alkaline phosphatase =< 2.5 x ULN (unless bone metastasis is present in the absence of liver metastasis, in which case 3.0 x ULN would be acceptable) Alkaline phosphatase =< 2.5 x upper limit of normal (< 5 X ULN for subjects with bone or liver metastasis) Alkaline phosphatase < 2.5 times the upper limit of normal, unless bone metastasis is present in the absence of liver metastasis Adequate liver function as demonstrated by:Total bilirubin of ?1.5 mg/dL or ?2.0 mg/dL for subjects with liver metastasis, Alanine aminotransferase ?3 x upper limit of normal (ULN) or ?5 x ULN if liver metastasis is present, Alkaline phosphatase ?3 x ULN or ?5 x ULN if bone or liver metastasis is present