Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases)Xx_NEWLINE_xXAlkaline phosphatase must be within the range allowing for eligibility, must be obtained < 2 weeks prior to randomizationXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x the institutional ULNXx_NEWLINE_xXAlkaline phosphatase (ALK Phos) =< 2.5 x institutional ULNXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x IULN within 28 days prior to registrationXx_NEWLINE_xXWithin 6 weeks prior to randomization: Alkaline phosphatase must be =< 2.5 x ULN for the labXx_NEWLINE_xXAlkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement)Xx_NEWLINE_xXAlkaline phosphatase (ALP) =< 2.5 x ULN measured within 28 days prior to randomizationXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x IULN, obtained within 28 days prior to step 2 registrationXx_NEWLINE_xXAlkaline phosphate =< 3 x normalXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)Xx_NEWLINE_xXObtained 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; andXx_NEWLINE_xXAlkaline phosphatase =< 3 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x institutional ULN, within 21 days prior to registrationXx_NEWLINE_xXAlkaline phosphatase within upper limits of institutional normal within 14 days prior to study entryXx_NEWLINE_xXAlkaline phosphatase =< 2 x IULNXx_NEWLINE_xXPatients must have alkaline phosphatase =< 2.5 x IULN within 14 days prior to registrationXx_NEWLINE_xXAlkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases)Xx_NEWLINE_xXAlkaline phosphatase =< 3X the institutional ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x institutional upper limit of normalXx_NEWLINE_xXAlkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN)Xx_NEWLINE_xXAST (SGOT), ALT (SGPT) and Alkaline phosphatase 2.5 times upper limit of normal (if liver metastases are present, then 5 x ULN is allowed)Xx_NEWLINE_xXAlkaline phosphatase ? 2.5 x ULN, unless the elevated alkaline phosphatase is due to bone metastasis.Xx_NEWLINE_xXSerum 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 metastasesXx_NEWLINE_xXWithin 30 days prior to enrollment: Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase ? 2.5 × ULN;Xx_NEWLINE_xXAlkaline phosphatase =< 2 × ULN (=< 5 × ULN if considered due to tumor)Xx_NEWLINE_xXaspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ? 5 times the upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline 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 phosphataseXx_NEWLINE_xXAlkaline phosphatase < 5 times ULNXx_NEWLINE_xXAST and/or ALT > 1.5 x ULN with concomitant alkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2.5 x the ULN or < 5 x the ULN if secondary to liver metastasisXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x IULN, unless bone metastasis is present in the absence of liver metastasisXx_NEWLINE_xXSerum alkaline phosphatase =< 5 x institutional ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 × ULNXx_NEWLINE_xXAlkaline phosphatase > 3 ULNXx_NEWLINE_xXAlkaline phosphatase =< 4 times the upper limit of normal (unless clinically considered to be related to liver involvement with leukemia)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN (or =< 5 x ULN for subjects with liver metastasis)Xx_NEWLINE_xXAlkaline phosphatase =< 5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase should be less than or equal to 2.5 x ULN (CTCAE v4.0, grade 1)Xx_NEWLINE_xXAlkaline (Alk.) phosphatase =< 3 x ULN unless evidence of the direct liver involvement by lymphoma - then =< 5 x ULN obtained =< 14 days prior to registrationXx_NEWLINE_xXHave an alanine aminotransferase (ALT) ?3.0 × ULN. (Note: There are no specific requirements for AST or alkaline phosphatase.)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases)Xx_NEWLINE_xXalkaline phosphatase must be ? 2.5 x ULN for the lab; andXx_NEWLINE_xXGamma-glutamyl transferase (GGT) alkaline phosphatase ? 2.5 × ULN.Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN; (=< 5 x ULN in case of bone metastasis)Xx_NEWLINE_xXAlkaline phosphatase (ALP) =< 3.0 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 times the upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN, within 14 days prior to registrationXx_NEWLINE_xXAlkaline phosphatase =< 2.5 X institutional upper limit of normal, determined within 14 days of registrationXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 5 x upper limit normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit of normal (ULN) or =< 5 X ULN if bone metastases (mets) are presentXx_NEWLINE_xXAlkaline phosphatase (ALP) =< 5.0 x ULN, at the screening visitXx_NEWLINE_xXAlkaline phosphatase (ALP) ? 2.5 × ULN (? 5 × ULN if disease-related/in the case of liver metastases).Xx_NEWLINE_xXAspartate 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 ULNXx_NEWLINE_xXARM 2 - A: AST/ALT/alkaline phosphatase: =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase =< 3 x ULN =< 28 days prior to registrationXx_NEWLINE_xXAlkaline phosphatase ? 3 x ULN or ? 5 x ULN if bone metastasis is presentXx_NEWLINE_xXAlkaline phosphatase up to 2.5 x ULN.Xx_NEWLINE_xXPatients with isolated elevations in alkaline phosphatase (ALP) < 5 x ULN in the presence of bony disease are not excluded from participating in the studyXx_NEWLINE_xXCOHORT B ONLY: Obtained =< 14 days prior to registration: alkaline phosphatase =< 750 U/LXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXPART I: Alkaline phosphatase (Alk PO4) =< 3 x the upper limits of normal (except for patients with documented metastatic disease to bone and/or liver)Xx_NEWLINE_xXSerum alkaline phosphatase (ALP) > 2 x ULNXx_NEWLINE_xXBilirubin <= 1.5 mg/dL; ALT, AST, and alkaline phosphatase <= 3.0x the upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 2 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN or =< 5 x ULN if judged by the investigator to be related to liver metastasesXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN with the following exception: patients with documented liver involvement or bone metastases: alkaline phosphatase =< 5 x ULN.Xx_NEWLINE_xXAlkaline phosphatase < 3 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase less than 1.5 times ULN (grade 1)Xx_NEWLINE_xXPatients with any elevated alkaline phosphatase due to bone metastasis can be enrolledXx_NEWLINE_xXAlkaline phosphatase >= 3 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase =< 3 x upper limit of normalXx_NEWLINE_xXSTUDY 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.Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x institutional upper limit of normalXx_NEWLINE_xXALT or aspartate AST > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase (ALP) =< 2.5 x ULN or =< 5.0 x ULN for patients with bone metastasesXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN; =< 5 x ULN for patients with documented liver involvement or bone metastases.Xx_NEWLINE_xXAlkaline phosphatase =< 3 X the upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 times the ULN (=< 5 x ULN for patients with liver involvement)Xx_NEWLINE_xXAST and ALT =< 1.5 x ULN, with alkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2.5 × ULNXx_NEWLINE_xXSerum alkaline phosphatase =< 5 X ULNXx_NEWLINE_xXObtained =< 14 days prior to registration: Alkaline phosphatase =< 3 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN for the institution within 14 days of study registrationXx_NEWLINE_xXAlkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4.03 grade 1)Xx_NEWLINE_xXAlkaline phosphatase =< 5 x ULN must be met during screening (within 21 days) and also prior to study drug administration on cycle 1 day 1Xx_NEWLINE_xXWithin 14 days prior to registration: Alkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline 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.Xx_NEWLINE_xXLiver function tests meeting one of the following criteria:\r\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) with alkaline phosphatase < 2.5 x ULN OR\r\n* AST and ALT < 1.5 x ULN, with alkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 4 x ULN.Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN with the exception that patients with documented liver involvement or bone metastases: alkaline phosphatase =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 x institutional upper limit of normal within 30 days of registrationXx_NEWLINE_xXObtained 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 metastasesXx_NEWLINE_xXAlkaline phosphatase (alk phos) < 2.5 X ULNXx_NEWLINE_xXSerum alkaline phosphatase (ALP) =< UNL or =< 2.5 x upper limit of normal (ULN) in case of liver and bone metastasesXx_NEWLINE_xXAlkaline phosphatase < 5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase (ALP) > or = 5 x upper limit of normal (ULN).Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 X ULNXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline 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 =< ULNXx_NEWLINE_xXAlkaline (Alk) phosphatase < 2.5 x ULNXx_NEWLINE_xXHepatic impairment, defined as alkaline phosphatase =< 2 x institutional ULN, within 21 days of initiation of protocol therapyXx_NEWLINE_xXHepatic impairment, defined as alkaline phosphatase > 2 x institutional ULN, within 21 days of initiation of protocol therapyXx_NEWLINE_xXAlkaline phosphatase (ALP) =< 5.0 x ULNXx_NEWLINE_xXAlkaline phosphatase (Alk Phos) greater than 2.5 times the upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 3 x ULNXx_NEWLINE_xXDetermined within 3 weeks of treatment initiation: Alkaline phosphatase < 5 x ULNXx_NEWLINE_xXBilirubin >2.0; alkaline phosphatase >5x upper limit of normal (ULN); ALT/AST >2x ULN.Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 institutional upper limit of normal of =< 5 x ULN if liver metastases are presentXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN prior to biopsyXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver or bone involvement of their cancer)Xx_NEWLINE_xXWithin 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 ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN with the following exception:\r\n* Patients with documented liver involvement or bone metastases: alkaline phosphatase =< 5 x ULNXx_NEWLINE_xXFULL STUDY INCLUSION CRITERIA: Alkaline phosphatase (ALP) limit =< 2.5 x ULN (=< 5 x ULN for patients with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline 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 ULNXx_NEWLINE_xXTotal bilirubin and alkaline phosphatase (ALP) =< 2 x ULN or =< 3 x ULN for Gilbert's diseaseXx_NEWLINE_xXAlkaline phosphatase (ALP) < 2.5 x ULNXx_NEWLINE_xXAlkaline 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 ULNXx_NEWLINE_xXObtained =< 7 days prior to registration: Alkaline phosphatase < 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x normal prior to biopsyXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline 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 requiredXx_NEWLINE_xXAlkaline phosphatase =< 2 times upper limit normalXx_NEWLINE_xXAlkaline phosphatase < 3 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN with the following exception; alkaline phosphatase (ALP) =< 5 x ULN in patients with bone metastasesXx_NEWLINE_xXAlkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase > 5 X upper limits of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase levels =< 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase (ALP) =< 2.5 x ULNXx_NEWLINE_xXSerum alkaline phosphatase less than 2.5 times the upper limits of normalXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN unless bone metastases presentXx_NEWLINE_xXAlkaline phosphatase (ALP) < 2.5 x ULN (3 x ULN for subjects on chronic anticonvulsive therapies).Xx_NEWLINE_xXAlkaline phosphatase =< to 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 X ULN, unless bone metastasis is present (< 5 X ULN) in the absence of liver metastasisXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present)Xx_NEWLINE_xXAlkaline phosphatase (ALP) =< 5.0 x ULNXx_NEWLINE_xXAlkaline phosphatase ? 2.5 x ULN (? 5.0 x ULN if bone or liver metastases present)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit (UL)Xx_NEWLINE_xXAlkaline phosphatase < 5 x ULN obtained =< 7 days prior to registrationXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x institutional ULN obtained within 14 days of first treatmentXx_NEWLINE_xXFor subjects without extensive bone metastases: alkaline phosphatase levels < 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase (Alp) =< 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase (ALP) =< 2 x ULNXx_NEWLINE_xXCAPMATINIB INCLUSION CRITERIA: Alkaline phosphatase (ALP) =< 5 x ULNXx_NEWLINE_xXCERITINIB INCLUSION CRITERIA: Alkaline phosphatase (ALP) =< 5 x ULNXx_NEWLINE_xXREGORAFENIB INCLUSION CRITERIA: Alkaline phosphatase (ALP) =< 2.5 x ULN if no liver metastases are present; =< 5 x ULN if bone or liver metastases are presentXx_NEWLINE_xXPHASE I: Alkaline phosphatase (ALP) < 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancyXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase (ALP) =< 5.0 x ULNXx_NEWLINE_xXAlkaline phosphatase (Alk phos) =< 5 X ULNXx_NEWLINE_xXAlkaline Phosphatase less than 2.5 x ULN (CTCAE Grade 1)Xx_NEWLINE_xXAlkaline 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 ULNXx_NEWLINE_xXAlkaline phosphatase < 5 x upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase =< 2 x upper limit of normal, unless proven to be due to disease involvementXx_NEWLINE_xXAlkaline phosphatase < 2.5 upper limit of normal (ULN) (< 10 x ULN in presence of bone metastases) within 14 days of study entryXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN for the laboratory (=< 5 x ULN for patients with cancer involving the liver and/or bone)Xx_NEWLINE_xXAlkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXADDITIONAL CRITERIA FOR STUDY CONTINUATION: Alkaline phosphatase (alk phos) =< 5 X upper level of normalXx_NEWLINE_xXSerum glutamic-oxaloacetic transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4 grade 1)Xx_NEWLINE_xXAlkaline phosphatase (AP) ? 2.5 x ULN, unless considered due to organ leukemic involvement;Xx_NEWLINE_xXAspartate 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 ULNXx_NEWLINE_xXAlkaline phosphatase < 2.5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase > 2.5 x the ULN, there is no upper limit if bone metastasis is present in the absence of liver metastasisXx_NEWLINE_xXAlkaline 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)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN, unless bone metastasis is present in the absence of liver metastasisXx_NEWLINE_xXAlkaline phosphatase (alk phos) < 2.6 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasisXx_NEWLINE_xXAlkaline phosphatase (ALP) =< 5.0 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 times the upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x ULN, obtained =< 14 days prior to registrationXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 3 x upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase < 2.5 times the upper limit of normalXx_NEWLINE_xXAlkaline phosphatase < 5 times the upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 2.5 ULNXx_NEWLINE_xXAlkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2.5 x ULNXx_NEWLINE_xXSerum alkaline phosphatase =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2 upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase less than 1.5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 3 x ULN (in the case of liver metastases, =< 5 x ULN)Xx_NEWLINE_xXAlkaline phosphatase < 2.5 times normalXx_NEWLINE_xXAlkaline phosphatase =< 3 x ULN (=< 5 x ULN with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline (Alk) phosphatase (Phos) =< 5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase must be =< 4 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase < 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 5 x the upper limit of normal; serum bilirubin > 2.0 is acceptable in the setting of known Gilbert’s syndromeXx_NEWLINE_xXAlkaline phosphatase =< 2 x ULN or considered not clinically significantXx_NEWLINE_xXSerum 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 treatmentXx_NEWLINE_xXBilirubin, aspartate aminotransferase (AST), alkaline phosphatase (ALK) =< 2 x normalXx_NEWLINE_xXAspartate aminotransferase (AST) and alkaline phosphatase < 5 x upper limit of normalXx_NEWLINE_xXAST and alkaline phosphatase < 5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase (ALP) < 5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase (ALP) < 5 x normalXx_NEWLINE_xXAlkaline phosphatase (ALP) levels > 2.5 × ULN.Xx_NEWLINE_xXObtained =< 14 days prior to registration: Alkaline phosphatase =< 750 U/LXx_NEWLINE_xXAlkaline phosphatase < 4 times the upper limit of institutional normalXx_NEWLINE_xXAlkaline phosphatase ?2.0×ULN.Xx_NEWLINE_xXAST (SGOT), ALT (SGPT) and Alkaline phosphatase > 2.5 times ULNXx_NEWLINE_xXAlkaline phosphatase must be no more than 2.5 times upper limit of normal unless due to disease involvement of the liverXx_NEWLINE_xXAlkaline phosphatase ? 2.5 × ULN (? 5 ± ULN for patients with documented liver involvement or bone metastases)Xx_NEWLINE_xXAlkaline phosphatase ?5 x ULNXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Alkaline phosphatase < 2 x ULNXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Alkaline phosphatase < 2 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2.5 X ULNXx_NEWLINE_xXWithin 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.Xx_NEWLINE_xXAlkaline phosphatase level =< upper limit of normal (ULN)Xx_NEWLINE_xXWithin 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 ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 X ULN unless due to direct lymphoma involvement, and then =< 5 X ULNXx_NEWLINE_xXAlkaline phosphatase < 5 times upper limit of normalXx_NEWLINE_xXAlkaline phosphastase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase < 252 u/LXx_NEWLINE_xXAlkaline 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 ULNXx_NEWLINE_xXAlkaline phosphatase < 2.0 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2.0 x ULN (if liver or bone disease are present, < 3.0 x ULN)Xx_NEWLINE_xXAlkaline phosphatase must be =< 3 x ULN for the lab within 28 days before randomizationXx_NEWLINE_xXAlkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement)Xx_NEWLINE_xXPerformed within 14 days prior to study: Alkaline phosphatase < 3 times the upper limits of the institutional normalXx_NEWLINE_xXAlkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases)Xx_NEWLINE_xXAlkaline phosphatase (ALP) < 3 x ULNXx_NEWLINE_xXAlkaline phosphatase (ALK Phos) =< 2.5 X institutional upper limit of normalXx_NEWLINE_xXDOSE ESCALATION COHORT: Alkaline phosphatase (ALP) ? 2.5 X ULNXx_NEWLINE_xXAlkaline phosphatase =< 4 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXAlkaline phosphatase < 3 times upper limit of institutional normalXx_NEWLINE_xXAlkaline phosphatase (ALP) > 250 U/LXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline (Alk) phosphatase =< 5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase > 3 x normalXx_NEWLINE_xXAlkaline phosphatase (ALK Phos) < 2.5 x ULNXx_NEWLINE_xXWithin 14 days of registration: Alkaline phosphatase =< 5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x institutional upper limit of normalXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5.0 x ULN for subjects with intrahepatic involvement of their cancer)Xx_NEWLINE_xXAlkaline 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 ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 X institutional upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN; if liver involvement, alkaline phosphatase =< 5.0 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN for the institutionXx_NEWLINE_xXAlkaline phosphatase must be =< 2.5 x ULN for the labXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 X institutional upper limit of normalXx_NEWLINE_xXSerum 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 ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastasesXx_NEWLINE_xXAlkaline phosphatase less than or equal to 2.5 x ULN (CTEP CTCAE version 4.0, grade 1)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasisXx_NEWLINE_xXNo history of severe prior or ongoing chronic liver disease; alkaline phosphatase < 5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase >= 2 x institutional ULN, within 21 days of initiation of protocol therapyXx_NEWLINE_xXAlkaline 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 metastasisXx_NEWLINE_xXAlkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is present in the absence of liver metastasisXx_NEWLINE_xXAlkaline phosphatase =< 3.0 x ULN; up to 5 x ULN is acceptable if due to bone metastases in the absence of liver metastasesXx_NEWLINE_xXAlkaline phosphatase ?2.0 x ULN or ?5 x ULN in case of bone metastasis and/or hepatic metastasisXx_NEWLINE_xXInadequate organ function per protocol-specified total bilirubin, AST and ALT, creatinine clearance and alkaline phosphatase.Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit of normal (ULN); patients with hepatic and/or bone metastases: alkaline phosphatase =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase >= 2 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2 x IULN be obtained within 42 days prior to registrationXx_NEWLINE_xXAlkaline phosphatase <3.0 x ULN or ?5.0 x ULN if liver or bone metastases presentXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x ULN (institutional)Xx_NEWLINE_xXAlkaline phosphatase ? 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN for the institutionXx_NEWLINE_xXAlkaline phosphatase less than or equal to 2.5 x ULNXx_NEWLINE_xXAST(SGOT), ALT(SGPT), or alkaline phosphatase (ALP) ? 2.5 x ULN.Xx_NEWLINE_xXAlkaline phosphatase levels ? 2.5 × ULN (? 5 × ULN in subjects with liver metastasis)Xx_NEWLINE_xXAlkaline phosphatase greater than 2.5 x ULN (CTCAE v4.0 grade 1) (if known hepatic metastases alkaline phosphatase may be =< 5 x ULN)Xx_NEWLINE_xXAlkaline phosphatase* less than or equal to 2.5 x ULNXx_NEWLINE_xX* Patients with a history of Gilbert’s syndrome may be eligible provided total bilirubin is less than or equal to 1.5 x ULN and the AST, ALT, and alkaline phosphatase meet the criteria detailedXx_NEWLINE_xXAlkaline (Alk.) phosphatase =< 3 x ULN unless evidence of the direct liver involvement by lymphoma – then =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 1.5 UNLXx_NEWLINE_xXalkaline phosphatase must be less than or equal to 2 x ULN; andXx_NEWLINE_xXalanine transaminase, aspartate aminotransferase and alkaline phosphatase ?3 × ULN or <5 × ULN in cases of liver involvementXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase < 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 x institutional normalXx_NEWLINE_xXAspartate 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 ULNXx_NEWLINE_xXAlkaline phosphatase (ALP) ? 3.0 × ULN (< 5 × ULN if isolated ALP increase, i.e., without ALT/AST or bilirubin increase).Xx_NEWLINE_xXAlkaline phosphatase ?2.0×ULNXx_NEWLINE_xXAlkaline phosphatase <3.0 x ULN or ?5.0 x ULN if liver or bone metastases presentXx_NEWLINE_xXAlkaline phosphatase limit ? 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase less than or equal to 3 x ULNXx_NEWLINE_xXAlkaline phosphatase (ALP) >5 xULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 times the upper limit of normal, unless bone metastasis is present in the absence of liver metastasisXx_NEWLINE_xXAlkaline phosphatase =< 5 X upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase < 2 x upper limit of normal, or considered not clinically significant by the study doctor or designeeXx_NEWLINE_xXAlkaline phosphatase less than or equal to 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < or equal to 4 x ULN if not related to leukemic diseaseXx_NEWLINE_xXAlkaline phosphatase (ALP) =< 2.5 x ULN unless considered tumor-relatedXx_NEWLINE_xXAlkaline phosphatase (ALP) =< 2.5 x ULN unless considered tumor relatedXx_NEWLINE_xXAlkaline phosphatase (ALP) =< 2.5 x ULN unless considered tumor relatedXx_NEWLINE_xXAlkaline phosphatase ? 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2.0 x ULN (if liver or bone metastases are present, < 3.0 x ULN)Xx_NEWLINE_xXWithin 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 ULNXx_NEWLINE_xXAlkaline phosphatase within 3 times the upper limits of normalXx_NEWLINE_xXAlkaline phosphatase within 5 times ULNXx_NEWLINE_xXAlkaline phosphatase ? 5X ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase =< 3 x ULN (=< 5 x ULN if liver or bone involvement)Xx_NEWLINE_xXObtained =< 7 days prior to registration:\r\nAlkaline phosphatase =< 3 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2 x ULN (if known liver or bone disease)Xx_NEWLINE_xXAlkaline phosphatase (ALP) =< 2.5 x ULN (within 7 days prior to registration)Xx_NEWLINE_xXAlkaline (Alk.) phosphatase =< 3 x ULNXx_NEWLINE_xXAlkaline phosphatase: ? 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN obtained =< 14 days prior to registrationXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase > 3 x institutional ULN, within 21 days of initiation of protocol therapyXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for patients with liver involvement of their cancer) (obtained =< 7 days prior to randomization)Xx_NEWLINE_xXAlkaline phosphatase =< 3 x ULNXx_NEWLINE_xXAlkaline phosphatase (AP) =< 2.0 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2 X institutional ULNXx_NEWLINE_xXAlkaline phosphatase < 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 5 x upper limit normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 times the institutional upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 5.0 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x IULNXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase (ALP) limit < 2.5 x ULN or =< 5.0 x ULN if liver metastases are presentXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN; if bone metastasis is present in the absence of liver metastasis then =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2.5 times institutional upper normal limit (unless due to disease involvement of the liver or bone marrow)Xx_NEWLINE_xXAlkaline phosphatase < 5 x ULNXx_NEWLINE_xXWithin 14 days of registration: Alkaline phosphatase =< 2.5 × institutional upper limit of normalXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase =< 3 X the upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase ? 2.5 times ULN (? 5 times ULN for patients with liver metastases);Xx_NEWLINE_xXAlkaline phosphatase >= 2.5 times ULNXx_NEWLINE_xXIf bone metastases are present and liver function is otherwise considered adequate by the Investigator then elevated alkaline phosphatase (ALP) will not exclude the patient.Xx_NEWLINE_xXAlkaline phosphatase > 3 x ULNXx_NEWLINE_xXAlkaline phosphatase > 2 x institutional ULNXx_NEWLINE_xXObtained 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 ULNXx_NEWLINE_xXAlkaline phosphatase (Alp) =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlanine 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.Xx_NEWLINE_xXAlkaline phosphatase < 3 times normalXx_NEWLINE_xXSerum alkaline phosphatase should be =< 1.5 x institutional ULNXx_NEWLINE_xXAlkaline 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)Xx_NEWLINE_xXAlkaline phosphatase (Alk Phos) =< 2.5 x ULNXx_NEWLINE_xXAlkaline (Alk) phosphatase < 2.5 x ULNXx_NEWLINE_xXObtained =< 7 days prior to registration: Alkaline phosphatase =< 3 x ULNXx_NEWLINE_xXAlkaline phosphatase (AP) =< 3 x the ULN or =< 5 × the ULN in the presence of known liver metastasesXx_NEWLINE_xXAlkaline phosphatase >= 3 x ULNXx_NEWLINE_xXPatient has poor liver function (> 2.5 times normal of alkaline phosphatase [Alk phos]) suggestive of cirrhosis or steatohepatitisXx_NEWLINE_xXAlkaline phosphatase =< 2.5 times upper limit of normal (unless due to disease involvement of the liver or bone marrow)Xx_NEWLINE_xXAlkaline phosphatase (AP) =< 3 x institutional upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase ? 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase > 2.5 times upper normal limit (unless due to chronic GVHD)Xx_NEWLINE_xXAlkaline phosphatase (ALP) =< 2.5 x ULN unless considered tumor relatedXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 X ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN for the institutionXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN, CTCAE grade 1Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x institutional upper limit normalXx_NEWLINE_xXAlkaline phosphatase < 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x normal prior to biopsyXx_NEWLINE_xXAlkaline phosphatase no greater than 1.5 times ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN; unless elevated secondary to lymphoma involvement of the liverXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 times upper limit of normalXx_NEWLINE_xXAdequate liver functions: AST and ALT =< 3xULN, alkaline phosphatase =< 3.0x ULN, except if attributed to tumor, and bilirubin =< 2xULN.Xx_NEWLINE_xXFor subjects without extensive bone metastases: alkaline phosphatase levels =< 2.5 x ULNXx_NEWLINE_xXFor subjects with extensive bone metastases: alkaline phosphatase levels =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 x ULN (=< 5 x ULN with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase less than or equal to 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase values within the institutional ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases)Xx_NEWLINE_xXAlkaline 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 ULNXx_NEWLINE_xXAlkaline phosphatase limit <2.5 x ULN (<5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase ? 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXGamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), and alkaline phosphatase =< 2.5 x institutional ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 X ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase (Alp) =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x normal limitsXx_NEWLINE_xXAlkaline phosphatase less than 10 times the upper limit of normal (unless due to active myositis)Xx_NEWLINE_xXAlkaline phosphatase < 3 times the upper limit of laboratory normalXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 times upper limit of laboratory normalXx_NEWLINE_xXAlkaline phosphatase < 2.5 x ULNXx_NEWLINE_xXAspartate 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 investigatorXx_NEWLINE_xXAlkaline phosphatase =< upper limit of normal (ULN) and AST or ALT =< ULN eligibleXx_NEWLINE_xXAlkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT =< ULN eligibleXx_NEWLINE_xXAlkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT =< ULN eligibleXx_NEWLINE_xXAlkaline phosphatase > 5 x ULN and AST or ALT =< ULN ineligibleXx_NEWLINE_xXAlkaline phosphatase =< ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN eligibleXx_NEWLINE_xXAlkaline phosphatase > 5 x ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN ineligibleXx_NEWLINE_xXAlkaline phosphatase =< ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN eligibleXx_NEWLINE_xXAlkaline phosphatase > 5 x ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN ineligibleXx_NEWLINE_xXAlkaline phosphatase =< ULN and AST or ALT > 5 x ULN ineligibleXx_NEWLINE_xXAlkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT > 5 x ULN ineligibleXx_NEWLINE_xXAlkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT > 5 x ULN ineligibleXx_NEWLINE_xXAlkaline phosphatase > 5 x ULN and AST or ALT > 5 x ULN ineligibleXx_NEWLINE_xXAlkaline phosphatase (ALP) ?5 × ULN (except for subjects with hepatomegaly and isozymes specific to liver, rather than bone)Xx_NEWLINE_xXAlkaline phosphatase levels ? 2.5 × ULN (? 5 × ULN in subjects with liver metastasis)Xx_NEWLINE_xXAlkaline phosphatase less than or equal to 2.5 x upper limit of normal, CTCAE v 4.0 grade 1Xx_NEWLINE_xXAlkaline phosphatase (ALP) < 3 x UNLXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase =< 5.0 times the upper limit of normal unless hepatic dysfunction is related to liver involvement with diseaseXx_NEWLINE_xXAlkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4.0 grade 1)Xx_NEWLINE_xXHepatic: Bilirubin ? 2.5 mg/dL (except in the case of Gilbert's syndrome or ongoing hemolytic anemia); and ALT, AST and Alkaline Phosphatase ? 5 × ULN.Xx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver or bone involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase < 3 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 X upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 2 X ULNXx_NEWLINE_xXAlkaline phosphatase (hepatic) > 3 times the upper normal limitXx_NEWLINE_xXAlkaline phosphatase =< 2.5 times ULNXx_NEWLINE_xXAlkaline phosphatase ? 2.5 times the ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN for the institutionXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x IUNLXx_NEWLINE_xXAlkaline 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 ULNXx_NEWLINE_xXAlkaline Phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement)Xx_NEWLINE_xXSerum 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)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 3.0 x ULN; if liver involvement, alkaline phosphatase =< 5.0 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis in present in the absence of liver metastasisXx_NEWLINE_xXSerum alkaline phosphatase less than 2.5 times the upper limits of normalXx_NEWLINE_xXAlkaline 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.Xx_NEWLINE_xXAlkaline phosphatase must be =< 2.5 x ULN for the labXx_NEWLINE_xXAlkaline 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 =< ULNXx_NEWLINE_xXPatients with AST/ALT or alkaline phosphatase > ULN must have liver imaging that does not demonstrate metastatic diseaseXx_NEWLINE_xXAlkaline phosphatase (ALP) < 5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase above 2.5X the ULNXx_NEWLINE_xXAlkaline phosphatase =< 5 x UNLXx_NEWLINE_xXAlkaline phosphatase (ALP) =< 2.5 x ULN, with the following exceptions: patients with documented liver or bone metastases: ALP =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase (ALP) < 5 x ULNXx_NEWLINE_xXAlkaline phosphatase of =< 2 ULNXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 X institutional upper limit of normal, unless bone metastasis is present in the absence of liver metastasisXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase (Alk phos) =< 3.0 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.0 x ULN; if bone or liver metastases are present, =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase limit ? 2.5 x ULN (? 5 x ULN for subjects whose cancer involves their liver).Xx_NEWLINE_xXAlkaline phosphatase =< to 2.5 x ULNXx_NEWLINE_xXAlkaline 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)Xx_NEWLINE_xXAlkaline phosphatase =< 5 x institutional ULN obtained =< 7 days prior to registrationXx_NEWLINE_xXPart 2 only: plasma total bilirubin <= ULN; ALT and/or AST <= 1.5 X ULN concomitant with alkaline phosphatase <= 2.5 X ULN.Xx_NEWLINE_xXPart 2 only: Patients with plasma total bilirubin > ULN; ALT and/or AST > 1.5 X ULN concomitant with alkaline phosphatase > 2.5 X ULN.Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 × ULN (patients with hepatic and/or bone metastases: alkaline phosphatase =< 5 × ULN)Xx_NEWLINE_xXLiver: hepatomegaly on physical exam with elevated alkaline phosphatase > 1.5 x ULNXx_NEWLINE_xXAlkaline phosphatase ? 5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ? 5 times the upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN; except for patients with hepatic and/or bone metastases: alkaline phosphatase =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2 x ULN (< 5 x ULN in subjects whom the PI and sponsor agree that clinical data suggest extrahepatic source of elevation)Xx_NEWLINE_xXAlkaline phosphatase (AP) =/< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 x ULN, unless evidence of direct liver involvement by lymphoma, then =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase > 1.5 x ULN (unless due to lymphoma or a non-malignant, non-hepatic cause such as Paget's disease)Xx_NEWLINE_xXAlkaline phosphatase > 2 x upper limits of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)Xx_NEWLINE_xXAlkaline phosphatase =< 2.5 X upper limit of normalXx_NEWLINE_xXAlkaline phosphatase < 2 X upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit of normal (< 5 X ULN for subjects with bone or liver metastasis)Xx_NEWLINE_xXAlkaline phosphate =< 2.5 x ULN (within four weeks prior to the study)Xx_NEWLINE_xXAlkaline phosphatase < 2 times ULN, unless arising from boneXx_NEWLINE_xXBilirubin and Alkaline phosphatase (ALP) =< 2 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase < 2.5 times the upper limit of normal, unless bone metastasis is present in the absence of liver metastasisXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2 times ULN, unless arising from boneXx_NEWLINE_xXAlkaline phosphatase less than or equal to 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase (ALP) =< 5.0 x ULNXx_NEWLINE_xXAlkaline phosphatase < 3 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 3 x ULN unless due to direct lymphoma involvement, and then =< 5 x ULNXx_NEWLINE_xXSerum alkaline phosphatase < 2 x ULN, or considered not clinically significant by the study doctor or designeeXx_NEWLINE_xXAlkaline phosphatase (hepatic) > 3 times the upper normal limitXx_NEWLINE_xXAlkaline phosphatase < 2.5 X institutional upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 5x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase ? 2.5 times ULN (? 5 times ULN for patients with liver metastases);Xx_NEWLINE_xXAlkaline phosphatase =< 1.5 x upper limit of normal (ULN).Xx_NEWLINE_xXAlkaline phosphate > 1.5 x ULNXx_NEWLINE_xXObtained =< 30 days prior to registration: Alkaline phosphatase =< 3 x the institutional upper limit of normalXx_NEWLINE_xXPatients with plasma alkaline phosphatase greater than 190 IU/dLXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x the upper normal limitXx_NEWLINE_xXSerum alkaline phosphatase level >= 300 IU/L.Xx_NEWLINE_xXAlkaline 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 allowedXx_NEWLINE_xXAlkaline phosphatase ? 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlkaline phosphatase < 5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase < 3 times the upper limit of normal (alkaline phosphatase and aspartate aminotransferase [AST] cannot both exceed the upper limit of normal)Xx_NEWLINE_xXAlkaline phosphatase < 4 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x ULNXx_NEWLINE_xXAlkaline phosphatase (ALP) must be < 2 times the upper limit of normalXx_NEWLINE_xXAlkaline phosphatase < 2 x ULNXx_NEWLINE_xXAlkaline phosphatase < 5 x upper limit of normalXx_NEWLINE_xXFor patients with known bone metastases, alkaline phosphatase < 5 x ULN is acceptableXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXAlkaline phosphatase < 2 x ULNXx_NEWLINE_xXAlkaline phosphatase (ALK) =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXLiver alkaline phosphatase =< 3 x upper limit of normalXx_NEWLINE_xXAlkaline phosphatase < 2.5 x the upper limit of normalXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x institutional ULNXx_NEWLINE_xXAlkaline phosphatase within institutional limits of normal or judged to be not clinically significant by the investigatorXx_NEWLINE_xXAlkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x upper limit of institutional normalXx_NEWLINE_xXAlkaline phosphatase =< 2.5 time ULNXx_NEWLINE_xXAlkaline phosphatase =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXObtained 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)Xx_NEWLINE_xXAlkaline phosphatase < 2.5 × ULN unless hepatic metastases are present, then < 5 × ULNXx_NEWLINE_xXAlkaline phosphatase =< 2 X ULNXx_NEWLINE_xXAlkaline phosphatase (ALP) > 2.5 x ULRRXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x IULNXx_NEWLINE_xXAlkaline phosphatase (ALK phos) within 2 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x IULNXx_NEWLINE_xXIndividuals with alkaline phosphatase (ALP) > 2.5 x normal upper limit any time during the previous 2 monthsXx_NEWLINE_xXAlkaline phosphatase (AP) =< 3 X ULN, obtained within 14 days prior to PET scanXx_NEWLINE_xXSerum glutamic-oxaloacetic transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 x ULNXx_NEWLINE_xXGamma-glutamyl transpeptidase (GGT) > 2.5 x ULN if alkaline phosphatase > 2.5 x ULN obtained < 2 weeks prior to study enrollmentXx_NEWLINE_xXGamma-glutamyl transferase (GGT) > 2.5 x ULN IF alkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase must be less than 4 x upper limit of normalXx_NEWLINE_xXGamma glutamyl transpeptidase (GGT) > 2.5 x ULN IF alkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase (ALK phos) less than 4.0 times below or above the upper or lower limit rangeXx_NEWLINE_xXGamma-Glutamyl Transpeptidase (GGT) > 2.5 x ULN IF alkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase (ALK phos) less than 4.0 times below or above the upper or lower limit rangeXx_NEWLINE_xXAlkaline phosphatase =< 2 times the upper limit of normalXx_NEWLINE_xXGamma glutamyl transferase (GGT) > 2.5 x ULN IF alkaline phosphatase > 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x upper limits of normal if no liver metastases present; alkaline phosphatase =< 5 x upper limits of normal if liver metastases presentXx_NEWLINE_xXAlkaline phosphatase =< 2.5 x ULN in the absence of known bone metastases or =< 5.0 x ULN in the case of bone metastasesXx_NEWLINE_xXAlkaline phosphatase < 3 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 5 x ULNXx_NEWLINE_xXAlkaline phosphatase < 2.5 x ULNXx_NEWLINE_xXAlkaline phosphatase =< 190 IU/dLXx_NEWLINE_xXPatients with plasma alkaline phosphatase greater than 190 IU/dLXx_NEWLINE_xXAlkaline phosphatase within normal limitsXx_NEWLINE_xXAlkaline phosphatase (Alk phos) =< 2.5 X institutional upper limit of normalXx_NEWLINE_xXAlkaline phosphatase ? 2.5 x ULNXx_NEWLINE_xXAlkaline 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.Xx_NEWLINE_xX