PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: AST (SGOT) / ALT (SGPT): =< 3 x ULNXx_NEWLINE_xXMust have alanine transaminase (ALT) ? 3 × institutional upper limit of normal (ULN) [? 5 × ULN in presence of liver metastases] within 14 days prior to randomization.Xx_NEWLINE_xXEither alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to sub-study registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)Xx_NEWLINE_xXRe-registration: AST/ALT =< 3 x ULNXx_NEWLINE_xXSerum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x upper limit of normal (ULN) for age (except for patients with liver metastasis who may enroll if ALT < 5 times ULN for age)Xx_NEWLINE_xXRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST and ALT < 2.5 x upper limits of normal (ULN)Xx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x upper limit of normal (ULN) or =< 5 x ULN with metastatic liver disease within 14 days prior to registration.Xx_NEWLINE_xXAspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) ? 1.5 × institutional ULN.Xx_NEWLINE_xXObtained within 14 days prior to treatment start: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN); if the patient has liver metastases, ALT and AST must still be =< 2.5 x ULN; patients with liver metastases and AST/ALT above this limit will not be enrolledXx_NEWLINE_xXAdequate 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 ALPXx_NEWLINE_xXAST/ALT ?2.5 × ULNXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN (=< 5 x ULN if documented liver metastases are present)Xx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN.Xx_NEWLINE_xXAlanine aminotransferase (ALT) ? 2.5 × ULN without liver metastases; must be ? 5 × ULN with liver metastasesXx_NEWLINE_xXAlanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) each < 3×ULN; however, ALT, AST, and TBILI each ? 5×ULN is acceptable if the elevation is considered due to PTLD involvement of the liver.Xx_NEWLINE_xXSerum AST and ALT ? 3 X ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases, or > 5 times ULN in presence of liver metastasesXx_NEWLINE_xXAspartate aminotransferase (AST) > 2.5 times ULN if no demonstrable liver metastases, or > 5 times ULN in presence of liver metastasesXx_NEWLINE_xXAST < 2.5 x ULN (5.0 x ULN in the presence of liver metastasis)Xx_NEWLINE_xXALT < 2.5 x ULN (5.0 x ULN in the presence of liver metastasis).Xx_NEWLINE_xXObtained =< 14 days prior to registration: Aspartate transaminase (AST) =< 3 x ULN (=< 5 x ULN for patients with liver involvement)Xx_NEWLINE_xXAST/SGOT and ALT/SGPT ? 2.5 X ULNXx_NEWLINE_xXLiver function tests above the following limits at Screening: total bilirubin >1.5 x upper limit of normal (ULN) unless related to Gilbert's syndrome or hemolysis; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x ULN; for subjects with liver involvement, AST and/or ALT >5 x ULN;Xx_NEWLINE_xXAST and ALT must be less than or equal to 2.5 x ULN for the lab with the following exception: for patients with documented liver metastases, AST and ALT must be less than or equal to 5 x ULN.Xx_NEWLINE_xXAdequate liver function as demonstrated by: Total bilirubin of < upper limit of normal (ULN), Aspartate transaminase (AST) and alanine aminotransferase (ALT) ?1.5 × ULN, Alkaline phosphatase (ALP) ?2.5x ULN or <5x ULN if bone metastases are present, Normal serum albuminXx_NEWLINE_xXALP, ALT, and AST > 3 x ULN (>5 x ULN if subject has liver metastases)Xx_NEWLINE_xXCOHORT 2: AST (SGOT) and ALT (SGPT) =< 3 X ULN within 14 days of treatment initiationXx_NEWLINE_xXAST(SGOT)/ALT(SGPT) ? 2.5 X institutional ULNXx_NEWLINE_xXAST (SGOT) and ALT (SGPT) ? 2.5 x ULN.Xx_NEWLINE_xXPatients must exhibit adequate bone marrow, liver, and renal function, within 14\r\ndays prior to registration, defined as: \r\n* Absolute neutrophil count (ANC) >= 1,000/mm^3 (growth factor support is permitted)\r\n* Platelets >= 100,000/mm^3 (may be reached by transfusion)\r\n* Hemoglobin >= 10 gm/dl (may be reached by transfusion)\r\n* Glutamate pyruvate transaminase (GPT)/glutamate oxaloacetate transaminase (GOT) < 3 x upper limit of normal (ULN) (or < 5 x ULN in case of liver metastasis)\r\n* Bilirubin < 3 x ULN (or < 5 x ULN in case of liver metastasis)\r\n* Creatinine < 1.5 x ULNXx_NEWLINE_xXRANDOMIZED PHASE II CLINICAL TRIAL: Within 10 days of registration: AST (SGOT) and ALT (SGPT) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastasesXx_NEWLINE_xXWithin 3 weeks prior to study registration: \r\nAlanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) within 3 weeks prior to study registrationXx_NEWLINE_xXAST or ALT > 2.5 × ULN. For patients with liver metastasis AST or ALT > 5 × ULN.Xx_NEWLINE_xXSerum ALT and AST levels ?2.5 x ULNXx_NEWLINE_xXPTT =< 1.3 x ULNXx_NEWLINE_xXPTT > 1.3 x ULNXx_NEWLINE_xXAST and ALT are each ?5 × the ULN;Xx_NEWLINE_xXAspartate transaminase (AST), alanine transaminase (ALT) =< 3 × ULNXx_NEWLINE_xXChronic hepatitis B as defined below or elevated AST, ALT > 3 ULNXx_NEWLINE_xXSerum AST/ALT < 3X the upper limit of normal (ULN) for the reference lab (< 5X the ULN for patients with known hepatic metastases)Xx_NEWLINE_xXHas adequate hepatic function, defined as: AST/ALT levels =< 3 x ULN (if liver metastases are present, =< 5 x ULN) Bilirubin =< 1.5 x ULN.Xx_NEWLINE_xXAST/ALT =< 2.5 x the IULN or =< 5 x IULN for patients with liver metastasesXx_NEWLINE_xXAST (SGOT) >2x ULNXx_NEWLINE_xXHepatic: aspartate transaminase (AST)/alanine transaminase (ALT) ?2.5 x upper limit of normal (ULN); total or conjugated bilirubin ?1.5 x ULNXx_NEWLINE_xXAST/ALT (SGOT/SGPT) < 2 ULNXx_NEWLINE_xXAST and ALT ? 5 x ULNXx_NEWLINE_xXSerum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ? 3.0 x upper limit of normal (ULN). In the case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ? 5.0 x ULN.Xx_NEWLINE_xXAST and ALT must be ? 1.5 x ULN for the lab.Xx_NEWLINE_xXAspartate transaminase (AST; SGOT), alanine transaminase (ALT; SGPT) ? 2.5 × ULN, (or ? 5 × ULN if tumor involvement (liver) is present).Xx_NEWLINE_xXAlkaline 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.Xx_NEWLINE_xXENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: AST (SGOT)/ALT (SGPT) =< 5.0 X ULN if hepatic metastases are presentXx_NEWLINE_xXEXPANDED ACCESS COHORT: AST(SGOT)/ALT(SGPT) =< 2.5 x institutional ULN -OR- AST(SGOT)/ALT(SGPT)\t=< 5 x institutional ULN if liver metastases are presentXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 5 x ULNXx_NEWLINE_xXAST (SGOT)/ ALT (SGPT): ? 3.0 x institutional ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2 x ULN OR if hepatic involvement by lymphoma: ALT =< 5 x ULNXx_NEWLINE_xXAST(SGOT)/ALT(SGPT) for patients with documented liver metastases, =< 5 x institutional ULNXx_NEWLINE_xXAspartate transaminase (AST) or alanine transaminase (ALT) ? 3 x ULN, unless due to organ leukemic involvementXx_NEWLINE_xXAlanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3.0 x ULN; for patients with hepatic metastases, ALT and AST =< 5.0 x ULN are acceptable\r\n* Note: if a patient experiences elevated ALT > 5 x ULN and elevated total bilirubin > 2 x ULN, clinical and laboratory monitoring should be initiated by the investigator; for patients entering the study with ALT > 3 x ULN, monitoring should be triggered at ALT > 2 x baselineXx_NEWLINE_xXalanine aminotransferase (ALT) ? 2.5 × ULN or ? 5 × ULN for subjects with known hepatic metastasesXx_NEWLINE_xXClinically-significant inadequate hematological, hepatic and renal function, defined as: Neutrophil count < 1.5 x 10 9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine aminotransferase (ALT) > 2.5 x ULN or > 5 x ULN if patient has documented liver metastases; and serum creatinine > 1.5 x ULNXx_NEWLINE_xXAlanine transaminase (ALT)/aspartate transaminase (AST) ?2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXAST (SGOT) and ALT (SGPT) ? 2.5 × institutional upper limit of normal (ULN) [? 5 × ULN in presence of liver metastases]Xx_NEWLINE_xXINCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): AST and ALT: =< 3 x ULN or =< 5 x ULN for patients with liver metastases within 2 weeks of registrationXx_NEWLINE_xXINCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): AST and ALT: =< 3 x ULN or =< 5 x ULN for patients with liver metastases within 2 weeks of registrationXx_NEWLINE_xXSerum AST and/or ALT < 3 x institutional ULN.Xx_NEWLINE_xXAspartate aminotransferase > 2.5 times the ULN if no demonstrable liver metastases or > 5 times the ULN in the presence of liver metastases.Xx_NEWLINE_xXClinically significant (as determined by the investigator) hematological, hepatic and renal dysfunction, defined as: Neutrophil count < 1.5 x 10^9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x ULN; AST and/or ALT > 2.5 x ULN or > 5 x ULN if patient has documented liver metastases; and serum creatinine > 1.5 x ULNXx_NEWLINE_xXAdequate hepatic function (total bilirubin ? 1.5 × upper limit of normal [ULN] for the institution; aspartate transaminase (AST) and alanine transaminase (ALT) ? 2.5 × ULN.Xx_NEWLINE_xXAST ?2.5 x ULN (if liver or bone mets are present, ?5 x ULN)Xx_NEWLINE_xXALT ?2.5 x ULN (if liver or bone metastases are present, ?5 x ULN)Xx_NEWLINE_xXAST (SGOT)/ALT (SGPT) ?2 X ULN; ? 5 X ULN if there is liver involvement secondary to tumorXx_NEWLINE_xXALT and AST ? 3 × ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer or stent placement)Xx_NEWLINE_xXAST (SGOT) and ALT (SGPT) ? 2.5 x ULN.Xx_NEWLINE_xXAlanine transaminase (ALT) ? 3 times the ULN, unless determined to be directly due to lymphoma.Xx_NEWLINE_xXAspartate transaminase (AST) ? 3 times the ULN, unless determined to be directly due to lymphomaXx_NEWLINE_xXAspartate transaminase (AST) =< 3 x ULN, except for patients with liver metastasis, who are included if AST =< 5 x ULN, at the screening visitXx_NEWLINE_xXAlanine transaminase (ALT) =< 3 x ULN, except for patients with liver metastasis, who are only included if ALT =< 5 x ULN, at the screening visitXx_NEWLINE_xXALT and/or AST >2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastasesXx_NEWLINE_xXALT and AST ? 1.5 ULNXx_NEWLINE_xXAST or ALT > 2.5 × ULN. For patients with liver metastasis AST or ALT > 5 × ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 5 x upper limit of normal (ULN) for patients receiving MAC or ALT and AST =< 10 x ULN for patients receiving RIC, RIC-MMF, or IOC; patients who are above these bilirubin, ALT, or AST thresholds may be eligible for the RIC, RIC-MMF or IOC arms if evaluated by a hepatologist who deems the liver function test abnormalities to be potentially reversible with bone marrow transplantXx_NEWLINE_xXAST and/or ALT ?2.5× ULN, <5× ULN w/liver metastasesXx_NEWLINE_xXAST (SGOT)/ALT (SGPT) ?5 X institutional upper limit of normal if with liver metastases; ?2.5 X ULN if no liver metastasesXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAspartate transaminase/alanine transaminase (AST/ALT) ? 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXPHASE IB: Transaminases (AST and/or ALT) =< 2.5 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXAlanine aminotransferase ? 3 x ULN or ? 5 x ULN if liver metastasis is present.Xx_NEWLINE_xXALT/AST ? 2 times ULNXx_NEWLINE_xXAspartate 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 metastasisXx_NEWLINE_xXTransaminases =< 3.0 x ULN, except in known hepatic disease, wherein may be =< 5 x ULNXx_NEWLINE_xXAST or ALT > 2.5 x ULN; for patients with liver metastasis AST or ALT > 5 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) ? 3 x ULN for age, unless elevation is due to leukemic infiltrationXx_NEWLINE_xXAdequate bone marrow and major organ function to undergo a PBSC transplant determined within 30-60 days prior to enrollment using standard phase 1 criteria for organ function defined as:\r\n* Absolute neutrophil count (ANC) >= 1.5 x 10^9 cells/L\r\n* Platelets >= 75 x 10^9/L\r\n* Hemoglobin >= 8 g/dL\r\n* Aspartate and alanine aminotransferases (AST, ALT) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN, if documented liver metastases are present)\r\n* Total bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)\r\n* Creatinine < 2 mg/dl (or a glomerular filtration rate > 60)\r\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1Xx_NEWLINE_xXAST/SGOT and ALT/SGPT ? 3.0 x ULNXx_NEWLINE_xXALT and AST ?2.5 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) greater than 2.0 times the ULN in the absence of known hepatic metastasesXx_NEWLINE_xXALT or AST greater than 3.0 times the ULN in the presence of known hepatic metastasesXx_NEWLINE_xXWithin 28 days prior to registration: Alanine aminotransferase (ALT) =< 2.5 x ULN (or =< 5 x ULN if liver metastases)Xx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN unless demonstrated lymphoma involvement of the liver, performed within 14 days prior to day 1 of protocol therapyXx_NEWLINE_xXBilirubin =< 3 X ULN or < 5 X ULN in the presence of liver metastasesXx_NEWLINE_xXAST (SGOT) and ALT (SGPT) =< 5 x ULN in patients with documented hepatic involvement by lymphomaXx_NEWLINE_xXLiver Transaminases (ALT/AST) ? 2.5 x ULN, ? 5.0 x ULN if liver metastases presentXx_NEWLINE_xXCOHORT 2: TRIPLE NEGATIVE BREAST CANCER: AST and ALT levels =< 3 X ULNXx_NEWLINE_xXCOHORT 3: ENDOMETRIAL CANCER: AST and ALT levels =< 3 X ULNXx_NEWLINE_xXALT and AST 2.5-5 x IULNXx_NEWLINE_xXSerum ALT/AST ? 2.5 x ULNXx_NEWLINE_xXSerum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 upper limit of normal (ULN), or AST and ALT < 5 ULN if liver function abnormalities are due to underlying malignancy.Xx_NEWLINE_xXALT > 5x ULN, AST > 5x ULN, or total bilirubin > 3 mg/dL [SI: > 51 ?mol/L] within 7 days prior to Day 1Xx_NEWLINE_xXBilirubin >2.0; alkaline phosphatase >5x upper limit of normal (ULN); ALT/AST >2x ULN. For patients with hepatic metastases, ALT/AST >5x ULN is exclusionary.Xx_NEWLINE_xXAST and ALT with hepatic metastasis =< 5 x ULNXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) levels ? 2.5 × ULN or AST and ALT levels ? 5 x ULN (for subjects with documented metastatic disease to the liver)Xx_NEWLINE_xXAlanine transaminase (ALT) =< 1.5 x ULN.Xx_NEWLINE_xXObtained =< 14 days prior to registration: Aspartate transaminase (AST) =< 2 x ULN (=< 5 x ULN for patients with liver involvement)Xx_NEWLINE_xXObtained =< 14 days prior to registration: Alanine aminotransferase (ALT) =< 2 x ULN (=< 5 x ULN for patients with liver involvement)Xx_NEWLINE_xXAspartate transaminase (AST) or alanine transaminase (ALT) =< 3 x ULNXx_NEWLINE_xXObtained =< 14 days prior to registration: Aspartate transaminase (AST) =< 2.5 x ULN or =< 5 x ULN for subjects with liver metastasesXx_NEWLINE_xXALT ?3 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) ? 2.5 × ULN or ? 5 × ULN for subjects with known hepatic metastasesXx_NEWLINE_xXAdequate bone marrow and major organ function to undergo a PBSC transplant determined within 30-60 days prior to enrollment using standard phase 1 criteria for organ function defined as:\r\n* Absolute neutrophil count (ANC) >= 1.5 x 10^9 cells/L\r\n* Platelets >= 100 x 10^9/L\r\n* Hemoglobin >= 9 g/dL\r\n* Aspartate and alanine aminotransferases (AST, ALT) =< 2.5 x ULN (=< 5 x ULN, if documented liver metastases are present)\r\n* Total bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)\r\n* Creatinine < 2 mg/dl (or a glomerular filtration rate > 60)Xx_NEWLINE_xXAlanine transaminase (ALT) =< 2.5 x upper normal limit (ULN) (=< 5 x ULN for subjects with documented metastatic disease to the liver).Xx_NEWLINE_xXhave adequate hepatic function, defined as having a serum total bilirubin concentration ?1.5mg/d, or ?2 x the upper limit of normal (ULN) if associated with hepatobiliary metastases or Gilbert syndrome, and having serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations ?2.5 × ULN, or ?5 x ULN for patients with known hepatic metastases;Xx_NEWLINE_xXAspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ? 2.5 × ULN or AST and ALT levels ? 5 x ULN for subjects with documented metastatic disease to the liver; patient with history of unconjugated hyperbilirubinemia with otherwise acceptable liver enzyme levels (as per above criteria) may have higher bilirubin levelsXx_NEWLINE_xXObtained =< 28 days prior to registration: Aspartate transaminase (AST) AND alanine transaminase (ALT) =< 2.5 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) within 2.5 x ULN unless there are liver metastases in which case, ALT within 5 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) < 2.5 times upper limit of normal (ULN) or ALT < 5.0 times ULN in the presence of liver metastasesXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) ? 2 × ULN except for patients with known liver metastases, in which case aspartate transaminase or alanime transaminase may be ? 5.0 × ULNXx_NEWLINE_xXALT, AST > 2.5 ULN or total bilirubin > 1.5 ULN (not attributable to Gilbert’s)Xx_NEWLINE_xXWithin 14 days prior to cycle 1 day 1 of treatment: Alanine aminotransferase (ALT) =< 2.5 x ULN (5.0 x ULN if liver involvement)Xx_NEWLINE_xXAST (aspartate transaminase or SGOT)/ALT (alanine aminotransferase or SGPT) ? 3.0 x ULN and total bilirubin ? 2.0 x ULN with no evidence of cholestasisXx_NEWLINE_xXAlanine aminotransferase (ALT) within 2.5 x ULN unless there are liver metastases in which case, ALT within 5 x ULNXx_NEWLINE_xX• AST (SGOT) and ALT (SGPT) ? 3 times institutional ULN; if liver metastases are present, then ? 5 times ULN is allowed.Xx_NEWLINE_xXAST (aspartate aminotransferase) =< 2 x ULN\r\n* NOTE: ALT and/or AST may be =< 5 x ULN if due to liver metastases. If ALT or AST is > 2 and =< 5 x ULN in patients with liver metastasesXx_NEWLINE_xXHepatic impairment, defined as AST (SGOT), or ALT (SGPT) > 2 x institutional ULN, within 21 days of initiation of protocol therapy orXx_NEWLINE_xXAspartate transaminase (AST) =< 2.5 x ULN? alanine transaminase (ALT) =< 2.5 x ULN, except for patients with liver metastasis, who are only included if AST and ALT < 5 x ULNXx_NEWLINE_xXAST/ ALT ? 2.5x institutional ULNXx_NEWLINE_xXAST and ALT <2.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 ULN (for patients with liver metastasis up to =< 5 times of ULN is allowed)Xx_NEWLINE_xXDetermined within 3 weeks of treatment initiation: Alanine aminotransferase (ALT) =< 2.5 x ULN OR =< 5 x ULN for subjects with liver metastasesXx_NEWLINE_xXCabazitaxel: AST =< 1.5 x ULNXx_NEWLINE_xXAST and ALT>5xULNXx_NEWLINE_xXSerum ALT/AST ? 2.5 ULNXx_NEWLINE_xXALT and AST ? 3 x ULN or ? 5 x ULN if documented liver infiltration with leukemia cellsXx_NEWLINE_xXAspartate transaminase or alanine transaminase ?3 x ULN (?5x ULN in the presence of hepatic metastases)Xx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN (obtained within 28 days prior to first study treatment)\r\n* Subjects with documented liver metastases should have ALT =< 5 x ULNXx_NEWLINE_xXFor patients with Hodgkin lymphoma (HL) involvement of the liver, AST/ALT =< 5.0 x institutional ULN; total bilirubin within 3.0 x institutional ULNXx_NEWLINE_xXLYMPHODEPLETION: Alanine aminotransferase (ALT) =< 3.0 x ULN, obtained within 72 hrs prior to procurementXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) ? 3.0 x ULN within 14 days prior to the first study treatment (cycle 1, day 1) with the following exception:\r\n* Patients with liver involvement: AST and/or ALT ? 5 x ULNXx_NEWLINE_xXTo be performed within 10 business days prior to day 1: Alanine aminotransferase (ALT) =< 3 x ULN unless demonstrated Hodgkin lymphoma involvement of the liverXx_NEWLINE_xXLiver function: ALT and AST ? 2.5 × ULN; Total bilirubin ? 1.5 × ULN (or ? 3 times ULN for subjects with documented Gilbert's syndrome or for whom indirect bilirubin concentrations suggest an extra-hepatic source of elevation)Xx_NEWLINE_xXGrade 4 AST or ALT elevationXx_NEWLINE_xXAspartate amino transferase (AST) or alanine amino transferase (ALT) =< three times the upper limit of (institutional/central) normal (ULN) (if related to liver metastases =< five times ULN)Xx_NEWLINE_xXAST and ALT ? 3 x ULNXx_NEWLINE_xXAdequate 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 ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastasesXx_NEWLINE_xXAspartate aminotransferase (AST) >2.5 times ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastasesXx_NEWLINE_xXAspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase must be within the range allowing for eligibility at cycle 1 day 1 of TPF:\r\n* Alkaline (Alk) Phosphate (PHOS) =< upper limit of normal (ULN); AST or ALT =< ULN: Eligible\r\n* ALK PHOS =< ULN; AST or ALT > 1x but =< 1.5x: Eligible\r\n* ALK PHOS =< ULN; AST or ALT > 1.5x but =< 5x: Eligible\r\n* ALK PHOS =< ULN; AST or ALT > 5x ULN: Ineligible\r\n\r\n* ALK PHOS > 1x but =< 2.5x; AST or ALT >1x but =< 2.5x; AST or ALT =< ULN: Eligible\r\n* ALK PHOS > 1x but =< 2.5x; AST or ALT > 1x but =< 1.5x: Eligible\r\n* ALK PHOS > 1x but =< 2.5x; AST or ALT > 1.5x but =< 5x: Ineligible\r\n* ALK PHOS > 1x but =< 2.5x; AST or ALT > 5x ULN: Ineligible\r\n\r\n* ALK PHOS > 2.5x but =< 5x; AST or ALT =< ULN: Eligible \r\n* ALK PHOS > 2.5x but =< 5x; AST or ALT > 1x but =< 1.5x: Ineligible\r\n* ALK PHOS > 2.5x but =< 5x; AST or ALT > 1.5x but =< 5x: Ineligible\r\n* ALK PHOS > 2.5x but =< 5x; AST or ALT > 5x ULN: Ineligible\r\n\r\n* ALK PHOS > 5 ULN; AST or ALT =< ULN: Ineligible\r\n* ALK PHOS > 5 ULN; AST or ALT > 1x but =< 1.5x: Ineligible\r\n* ALK PHOS > 5 ULN; AST or ALT > 1.5x but =< 5x: Ineligible\r\n* ALK PHOS > 5 ULN; AST or ALT > 5x ULN: IneligibleXx_NEWLINE_xXSubjects with ALT > 5 x ULN at day 1 are not eligible for enrollmentXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 times the upper limit of normal (ULN); andXx_NEWLINE_xXAST and ALT < 2.5 x ULNXx_NEWLINE_xXALT or AST > 1.5 ULN in patients (pts) without liver metastasisXx_NEWLINE_xXFor pts with liver metastasis: ALT or AST > 2.5 ULNXx_NEWLINE_xXAST or ALT > 2.5 x ULNXx_NEWLINE_xXAcceptable coagulation status: INR ?2.0 x ULN and PTT ?2.0 x ULN.Xx_NEWLINE_xXObtained =< 14 days prior to randomization: Alanine transaminase (ALT) =< 2.5 x ULN (=< 5 x ULN for patients with liver involvement)Xx_NEWLINE_xXAspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) =< 5 times ULN (within 14 days prior to registration)Xx_NEWLINE_xXAspartate aminotransaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN OR =< 5.0 x ULN if liver metastases presentXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 times the upper limit of normal (ULN); andXx_NEWLINE_xXAspartate and alanine aminotransferases (AST, ALT) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN, if documented liver metastases are present)Xx_NEWLINE_xXAlanine aminotransferase (ALT) < 2.5 x ULN (3 x ULN for subjects on chronic anticonvulsive therapies known to increase transaminases).Xx_NEWLINE_xXAspartate aminotransaminase (AST), alanine aminotransaminase (ALT) within 2.5 x institutional upper limits of normal unless there are liver metastases in which case AST and ALT within 5.0 x ULNXx_NEWLINE_xXAdequate organ function as indicated by the following laboratory values. All laboratory tests must be obtained within 7 days prior to the first dose of ARQ 751: a. Hematological i. Absolute neutrophil count (ANC) ? 1.5 x 109/L ii. Platelet count (Plt) ? 100 x 109/L iii. Hemoglobin (Hb) ? 9 g/dL iv. International normalized ratio (INR) 0.8 to upper limit of normal (ULN) or ? 3 for subjects receiving anticoagulant therapy such as Coumadin or heparin b. Renal i. Serum creatinine ? 1.5 x ULN or calculated creatinine clearance ? 60 mL/min/1.73 m2 for subjects with serum creatinine levels > 1.5 x institutional ULN c. Hepatic i. Total bilirubin ? 1.5 x ULN ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 3 x ULN or ? 5 x ULN for subjects with known liver metastases d. Metabolic i. Glycated hemoglobin (HbA1c) ? 8%Xx_NEWLINE_xXAspartate aminotransferase > 2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastasesXx_NEWLINE_xXAlanine transaminase (ALT) or aspartate transaminase (AST) >= 2.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXAspartate transaminase (AST) =< 3 x ULN, except with liver involvement by the lymphoma who are only included if AST =< 5 x ULN; alanine transaminase (ALT) < 3.0 x ULN, except with liver involvement by the lymphoma who are only included if AST =< 5 x ULNXx_NEWLINE_xXAspartate Transaminase (AST) and alanine transaminase (ALT) =< 2.5 x institutional upper limit of normal (ULN) unless liver metastases are present, in which case it must be =< 5 x ULNXx_NEWLINE_xXIf liver metastasis present, then AST/ALT =< 5 x ULNXx_NEWLINE_xXSerum alanine transferase (ALT) and aspartate transaminase (AST) < 3 the upper limit of normal (ULN); < 5 ULN if there is liver involvement secondary to the tumorXx_NEWLINE_xXPatient must meet the following laboratory values at the screening visit: Absolute Neutrophil Count ?1.5 x 109/L. Platelets ?75 x 109/L. Hemoglobin (Hgb) ?9 g/dL. Serum creatinine <1.5 mg/dL. Total bilirubin ?1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). Aspartate transaminase (AST) ? 3.0 x ULN, except for patients with liver metastasis, who may only be included if AST ?5.0 x ULN. Alanine transaminase (ALT) ? 3.0 x ULN, except for patients with liver metastasis or tumor infiltration, who may only be included if ALT ?5.0 x ULN. Prothrombin time (PT)/International normalized ratio (INR) and Partial thromboplastin time (PTT) ?1.5xULN. Note: patients receiving therapeutic anticoagulation agents prior screening are permitted. Albumin 2.5 g/dL.Xx_NEWLINE_xXAdequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULNXx_NEWLINE_xXSerum aspartate aminotransferases (AST) or alanine aminotransferases (ALT) < 2.5 x IULN for patients without liver metastases; for patients with liver metastases AST or ALT < 5 x IULN is allowedXx_NEWLINE_xXALT/AST ? 2.5 times ULN, or < 5 times ULN for subjects with liver metastasesXx_NEWLINE_xXLiver enzymes: Aspartate transaminase (AST); Alanine transaminase (ALT) or Alkaline phosphatase (ALP) ?2.5 x ULN (or ?5.0 x ULN if liver involvement by primary disease);Xx_NEWLINE_xXSerum aspartate transaminase (AST) and serum alanine transaminase (ALT) ? 1.5 x upper limit of normal (ULN) with alkaline phosphatase ? 2.5 x ULN, or AST and ALT ? 5 x ULN if liver function abnormalities are due to liver metastasesXx_NEWLINE_xXalanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 x ULN (< 5 x ULN if documented hepatic metastases)Xx_NEWLINE_xXAlanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXSerum ALT, AST ? 2 × ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 3 x ULN for the laboratory, except in the presence of known hepatic metastasis, wherein the ALT may be =< 5 x ULNXx_NEWLINE_xXAST or ALT > 3 times ULN, AST or ALT > 5 times ULN for patients with liver metastases.Xx_NEWLINE_xXCERITINIB INCLUSION CRITERIA: AST (SGOT) and ALT (SGPT) =< 3 x ULN if no liver metastases are present? =< 5 x ULN if liver metastases are presentXx_NEWLINE_xXREGORAFENIB INCLUSION CRITERIA: AST (SGOT) and ALT (SGPT) =< 2.5 x ULN if no liver metastases are present? =< 5 x ULN if liver metastases are presentXx_NEWLINE_xXENTRECTINIB INCLUSION CRITERIA: AST (SGOT) and ALT (SGPT) =< 3.0 x ULN if no liver metastases are present? =< 5 x ULN if liver metastases are presentXx_NEWLINE_xXLiver: total bilirubin ? 1.5 x the upper limit of normal (ULN; unless known Gilbert's syndrome); alanine aminotransferase ? 2.5 x ULN (? 5.0 x ULN in patients with liver metastases).Xx_NEWLINE_xXPHASE II: AST and ALT < 3 x ULNXx_NEWLINE_xXAlanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) or alkaline phosphatase (ALP) > 2.5 ULN without hepatic metastases or ALT, AST or ALP > 5 ULN with hepatic metastasesXx_NEWLINE_xXAdequate hepatic function: bilirubin ?1.5 x upper limit of normal (ULN), AST ?2.5 x ULN, ALT ?2.5 x ULN, alkaline phosphatase (liver fraction) ?2.5 x ULNXx_NEWLINE_xXAdequate hepatic function with total bilirubin and ALT < 1.5X the upper limit of normal (ULN), except in patients with Gilbert's Syndrome must have a total bilirubin < 3X ULN and ALT < 3X ULN. In cases of known liver metastases, ALT ? 5X ULN is acceptable (total bilirubin must be < 1.5X ULN).Xx_NEWLINE_xXAlanine transaminase =< 3 x ULNXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 times the upper limit of normal ([ULN]; or 5.0 times the ULN in the setting of liver metastases)Xx_NEWLINE_xXLiver function abnormality as defined by total bilirubin >1.5 × ULN or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >2.5 × ULN (except for subjects with liver involvement, who can have AST/ALT >5 × ULN)Xx_NEWLINE_xXAspartate transaminase (AST) < 2.0 x ULN, except for patients with liver metastasis, who are only included if AST < 3 x ULN; alanine transaminase (ALT) < 2.0 x ULN, except for patients with liver metastasis, who are only included if ALT < 3 x ULNXx_NEWLINE_xXAST and ALT ? 3 x ULN for age unless elevation can be clearly attributed to liver leukemia or metastasesXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN; =< 5 x ULN if liver metastases are presentXx_NEWLINE_xXAST and ALT <3 x ULNXx_NEWLINE_xXAlanine transaminase (ALT) ?2.5 × ULN, or ?5 × ULN if leukemic infiltration of the liver is presentXx_NEWLINE_xXAspartate transaminase (AST) ?2.5 × ULN, or ?5 × ULN if leukemic infiltration of the liver is presentXx_NEWLINE_xXALT and AST ? 1.5 ULNXx_NEWLINE_xXPatients with abnormal hepatic function will be eligible and will be grouped according to criteria summarized below:\r\n* Group A: Normal hepatic function\r\n** Bilirubin =< ULN\r\n** Aspartate aminotransferase (AST) =< ULN\r\n* Group B: Mild hepatic dysfunction\r\n** B1: bilirubin =< ULN and AST > ULN\r\n** B2: ULN < bilirubin =< 1.5 x ULN and any AST\r\n* Group C: Moderate hepatic dysfunction\r\n** 1.5 x ULN < bilirubin =< 3 x ULN and any AST\r\n* Group D: Severe hepatic dysfunction\r\n** 3 x ULN < bilirubin =< 10 x ULN and any AST; hepatic function tests should be repeated within 24 hours prior to starting initial therapy and may result in patients’ group assignment being altered if different to registration test resultsXx_NEWLINE_xXInotuzumab within 30 days and must have ALT, AST and bilirubin < ULN.Xx_NEWLINE_xXARM B COHORT 2: AST and ALT =< 2 X ULN; if liver metastases are present then must be < 5 X the ULNXx_NEWLINE_xXARM B COHORT 3: AST and ALT =< 2 X ULN; if liver metastases are present then must be < 5 X the ULNXx_NEWLINE_xXARM C COHORT 4: AST and ALT =< 5 x ULNXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (ULN); for subjects with liver metastases, AST or ALT =< 5 X ULNXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (ULN); for subjects with liver metastases, AST or ALT =< 5 × ULNXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (ULN); for subjects with liver metastases, AST or ALT =< 5 × ULNXx_NEWLINE_xXPHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nAST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (ULN); for subjects with liver metastases, AST or ALT =< 5 X ULNXx_NEWLINE_xXFor subjects with liver metastasis, adequate liver function is demonstrated by serum bilirubin =< 2 x ULN and AST/ALT =< 5.0 x ULNXx_NEWLINE_xXAST and ALT ? 3 x ULN or ? 5 x ULN for subjects with known liver metastasesXx_NEWLINE_xXHepatic: Serum/plasma total bilirubin ?1.5 x upper limit of normal (ULN) with the exception of <2.9 mg/dL for patients with Gilbert's disease, ALT (SGPT) and AST (SGOT) ?2.5 x ULN.Xx_NEWLINE_xXALT/AST ? 2.5 times ULN, or < 5 times ULN for subjects with liver metastasesXx_NEWLINE_xXALT =< 3 x ULN (5.0 x ULN if considered to be due to leukemic involvement)Xx_NEWLINE_xXSGOT or SGPT > 4 x ULNXx_NEWLINE_xXAdequate liver function, as defined by AST and ALT ? 3 x ULN, and bilirubin ? 1.5 x ULN (unless documented Gilbert's syndrome).Xx_NEWLINE_xXAlanine transaminase (ALT) and aspartate aminotransferase (AST) < 1.5 x ULN (< 5 x ULN if patient has liver metastasis)Xx_NEWLINE_xXAST/ALT =<3 X ULN; -Bilirubin =<1.5 X ULN, unless resulting from hemolysisXx_NEWLINE_xXRETREATMENT WITH MODIFIED T CELLS: ALT (SGPT): =< 5 x ULNXx_NEWLINE_xXAspartate transaminase (AST) =< 3.0 x ULN, except for patients with liver metastasis, who are only included if AST =< 5 x ULN; alanine transaminase (ALT) < 3.0 x ULN, except for patients with liver metastasis, who are only included if ALT < 5 x ULNXx_NEWLINE_xXLaboratory values: Screening serum creatinine >1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9 g/dL, albumin <2 gm/dL.Xx_NEWLINE_xXAspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULNXx_NEWLINE_xXalanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 x ULN (< 5 x ULN if documented hepatic metastases)Xx_NEWLINE_xXSGPT (ALT) and SGOT (AST) less than or equal to 3 x normal for ageXx_NEWLINE_xXAspartate transaminase (AST) or alanine transaminase (ALT) =< 2.5 x ULNXx_NEWLINE_xXAlanine transaminase (ALT) =< 2 times the ULN or aspartate transaminase (AST) =< 2 times the ULN; this value must be obtained within two weeks before protocol entryXx_NEWLINE_xXB. Hepatic: Serum total bilirubin ?2.5 x upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) ?2.5 x ULN.Xx_NEWLINE_xXPatients must have adequate hepatic function as evidenced by AST and ALT values ? 3 X ULN (? 5 X ULN if the liver is known to be involved by metastatic disease) and serum total bilirubin values of ? 1.5 X ULN for the reference laboratory.Xx_NEWLINE_xXAspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 upper limit of normal (ULN)Xx_NEWLINE_xXAST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases)Xx_NEWLINE_xXtransaminases (AST or ALT) levels, 5 times greater than the ULN, except if related to ALL/LBL,Xx_NEWLINE_xXFor Phase I and II: Adequate liver (bilirubin </=2x ULN, ALT </=2.5x ULN) and renal (creatinine </=2x ULN) function. For patients with suspected liver infiltration from leukemia ALT should be </= 5 ULN.Xx_NEWLINE_xXAspartate and alanine aminotransferases (AST, ALT) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN, if documented liver metastases are present)Xx_NEWLINE_xXAlanine and aspartate transaminases (ALT and AST) =< 2.5 times the ULN (=< 5 x ULN for patients with liver involvement)Xx_NEWLINE_xXException for patients with liver metastasis: total bilirubin =< 3 x ULN; ALT (SGPT) =< 8 X ULNXx_NEWLINE_xXAlanine aminotransferase > 2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases; aspartate aminotransferase > 2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastasesXx_NEWLINE_xXObtained =< 28 days prior to randomization:\r\nAspartate transaminase (AST) =< 2.5 x ULN (or =< 5 x ULN in presence of liver metastases)Xx_NEWLINE_xXAdequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver)Xx_NEWLINE_xXAlanine aminotransferase (ALT) ?110 units per Liter (U/L). For the purpose of this study, the ULN for ALT is 45 U/LXx_NEWLINE_xXAlanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 x ULN (=< 5 x ULN for patients with liver involvement), obtained =< 14 days prior to registrationXx_NEWLINE_xXAdequate liver function (total bilirubin ?1.5 X ULN (or ?3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] ?3 X ULN (or ?5 X ULN for patients with liver involvement of their myeloid disease)Xx_NEWLINE_xXAST < 3.0 x ULNXx_NEWLINE_xXALT < 3.0 x ULNXx_NEWLINE_xXAST and ALT must be less than or equal to 2.5 x ULN for the lab with the following exception: for patients with documented liver metastases, AST and ALT must be less than or equal to 5 x ULN.Xx_NEWLINE_xXALT and AST >3.0 times the ULN if no liver involvement or >5 times the ULN with liver involvement.Xx_NEWLINE_xXAdequate baseline laboratory data: hemoglobin >9 g/dL, absolute neutrophil count (ANC) ?1,000/µL, CD4+ T-cells ?200/µL, platelets ?50,000/µL, bilirubin ?1.5 X upper limit of normal (ULN) or ?3 X ULN for patients with Gilbert's disease, serum creatinine ?1.5 X ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ?3 X ULN.Xx_NEWLINE_xXHave adequate organ function, confirmed by the following laboratory values obtained ? 3 days prior to the first treatment: absolute neutrophil count ? 1.5 × 10^9/L; hemoglobin ? 9 g/dL; platelets ? 100 × 10^9/L; aspartate transaminase and alanine transaminase ? 2.5 × upper limit of normal (ULN); serum total bilirubin ? 2.0 × ULN; serum creatinine ? 1.5 × ULN, or estimated or measured creatinine clearance ? 60 mL/min; prothrombin time, activated partial thromboplastin time ? 1.5 × ULN if not on anticoagulation therapyXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 times ULN; in the case of known (radiological and/or biopsy documented) liver metastasis, ALT =< 2.5 times ULN is acceptableXx_NEWLINE_xXAspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ? 3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ? 5 × ULN.Xx_NEWLINE_xXAST / ALT (SGPT) <2.5 x ULNXx_NEWLINE_xXAST and ALT ? 1.5 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN; note: if the patient has liver metastases present, then =< 5 x ULNXx_NEWLINE_xXAspartate 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 =< ULNXx_NEWLINE_xXAST (SGOT)/ALT (SGPT) less than or equal to 2.5 x institutional upper limit of normal (ULN) or less than or equal to 5.0 x ULN in patients with liver metastasesXx_NEWLINE_xXAST(SGOT)/ALT(SGPT): ?3 x UNLXx_NEWLINE_xX109 Laboratory parameters (completed within 14 days prior to enrollment): Hematology: Absolute neutrophil count (ANC) ? 1.0 x 10^9/L, Platelets ? 75 x 10^9/L. Chemistry: Creatinine clearance ? 50 mL/min (calculated using Cockcroft Gault equation). Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3X upper limit of normal (ULN), Total bilirubin (TBL) < 2x ULN (unless Gilbert's disease or if liver involvement with lymphoma)Xx_NEWLINE_xXHepatic: bilirubin < 1.5 times the upper limit of normal (ULN); alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) < 3.0 x ULN (AP, AST, and ALT < 5 x ULN is acceptable if the liver has tumor involvement).Xx_NEWLINE_xXWithin 14 days prior to randomization: Aspartate aminotransferase (AST) and alanine aminotransaminase (ALT) must be =< 2.5 x ULN for the lab or =< 5 x ULN for patients with liver metastases.Xx_NEWLINE_xXAST and ALT <3.0 x ULNXx_NEWLINE_xXSerum transaminases =< 3X ULN.\r\n* Note: Transaminases can be up to 5 X ULN in the setting of liver metastases.Xx_NEWLINE_xXTo be performed within 14 days prior to day 1 of protocol therapy: alanine aminotransferase (ALT) =< 3 x ULN\r\n* If hepatic involvement by lymphoma: ALT =< 5 x ULNXx_NEWLINE_xXALT/AST ? 2.5 times ULN, or < 5 times ULN for subjects with liver metastasesXx_NEWLINE_xXAdequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 x upper limit of normal (ULN), and total bilirubin ? 1.5 x ULN except Gilbert's Syndrome where a direct bilirubin ? 1.5 ULN will be used.Xx_NEWLINE_xXREGISTRATION TO TREATMENT (STEP 2): AST (SGOT) and ALT (SGPT) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases, within 14 days prior to first dose of pembrolizumabXx_NEWLINE_xXWithin 14 days of study drug(s) initiation: Alanine transaminase (ALT) and aspartate transaminase (AST) =< 2.5 x upper limit of normal (ULN) or =< 5 x ULN if known hepatic metastases.Xx_NEWLINE_xXAlanine aminotransferase (ALT) ? 3 x ULN OR ? 5 x ULN (if liver metastases present)Xx_NEWLINE_xXObtained =< 21 days prior to registration: Aspartate transaminase (AST) =< 3 x ULN, =< 5.0 x ULN for patients with metastatic disease to the liverXx_NEWLINE_xXObtained =< 21 days prior to registration: Aminotransferase (ALT) =< 3.0 x ULN, =< 5.0 x ULN for patients with metastatic disease to the liverXx_NEWLINE_xXAspartate transaminase (AST) and alanine aminotransaminase (ALT) =< 3 x ULNXx_NEWLINE_xXAspartate transaminase (AST) =< 3 X ULN unless due to direct lymphoma involvement, and then =< 5 X ULNXx_NEWLINE_xXAspartate transaminase (AST) and/or alanine transaminase (ALT) < 2.5 x upper normal limit (ULN)Xx_NEWLINE_xXNote: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =< 3.0 x ULN and ALT/AST are =< 5.0 x ULNXx_NEWLINE_xXAspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) =< 2.5 times the ULN except in patients with hepatic metastases for whom AST and ALT must be < 5.0 times the ULNXx_NEWLINE_xXTo be performed within 28 days prior to day 1 of protocol therapy: Alanine aminotransferase (ALT) =< 2.5 x ULN if no liver metastases or =< 5 x ULN if liver metastasesXx_NEWLINE_xXMust have adequate organ function as defined by the following values: white blood cells >3 x 10^9/liter(L); absolute neutrophil count (ANC) >= 1.5 x 10^9/L; hemoglobin >= 9 grams per decilitre (g/dL) subjects that required transfusion or growth factor need to demonstrate stable hemoglobin for 7 days of 9 g/dL; platelets >=100 x 10^9/L; prothrombin time (PT)/International normalized ration (INR) and partial thromboplastin time (PTT) <= 1.5 x upper limit of normal (ULN); albumin >=2.5 g/dL; total bilirubin <=1.5 x ULN; aspartate transaminase (AST) <=2.5 x ULN; alanine transaminase (ALT) <=2.5 x ULN OR <5 x ULN; creatinine <=1.5 x ULN is acceptable for subjects with documented liver metastases/tumor infiltration; creatinine clearance >= 50 mL/min; ejection fraction>= lower limit of normal (LLN) by echocardiogram or multigated acquisition (MUGA) and minimum of 50% left ventricular ejection fraction (LVEF); testosterone <=50 nanograms per deciliter (ng/dL)Xx_NEWLINE_xXAspartate transaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN OR =< 5 x ULN for subjects with liver metastases obtained =< 28 days prior to registrationXx_NEWLINE_xXHave serum aspartate aminotransferase (AST) > 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) > 5 times ULN at screening, or total bilirubin >= 3.0 x ULN at screening (except for documented Gilbert's syndrome), by local or central lab. Subjects with biopsy confirmed CMV hepatitis will not be excluded from study participation despite AST or ALT > 5 times ULN at screening.Xx_NEWLINE_xXChemistry: ALT/AST ? 3.0 x ULN, TBili ?1.5 x ULN, and Cr < 2 mg/dLXx_NEWLINE_xXAspartate aminotransferase (AST) must be =< 3 x ULN for the lab within 28 days before randomization;\r\n* Note: if alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 3 x ULN; if both were performed, the AST must also be =< 3 x ULN; if AST and/or ALT is >= ULN but =< 3 x ULN, serologic testing for hepatitis B and C must be performed and results for viral infection must be negativeXx_NEWLINE_xXSerum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U/LXx_NEWLINE_xXAdequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULN.Xx_NEWLINE_xXAspartate transaminase (AST)/alanine transferase (ALT) < 3.0 ULNXx_NEWLINE_xXARM B: obtained =< 14 days prior to registration: \r\n* AST/ALT =< 2.5 x ULNXx_NEWLINE_xXDOSE EXPANSION COHORT: ALT(SPGT) ? 2.5 X ULNXx_NEWLINE_xXSerum alanine aminotransferase (ALT), aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN) but =< 5.0 x ULN in case of liver metastases; in the presence of liver metastases the liver isoenzyme fraction must be measured and liver isoenzyme fraction (absolute value) must be =< 2 x ULNXx_NEWLINE_xXAspartate transaminase (AST) and/or alanine transaminase (ALT) =< 2.5 x ULN or =< 5 x ULN for patients with liver metastases, obtained =< 14 days prior to registrationXx_NEWLINE_xXAST/ALT > 2.5 X ULN or > 5 X ULN in the presence of liver metastases; current treatment with anti-androgen is allowed for a maximum of one month to prevent flare response with antiandrogen therapy (ADT)Xx_NEWLINE_xXAspartate transaminase (AST) or alanine transaminase (ALT) ? 2.5 x institutional ULN. If liver function abnormalities are due to metastatic disease, patients are eligible provided the ALT and AST are < 5 x ULNXx_NEWLINE_xXAST or ALT less than or equal to 2.5 X institutional ULNXx_NEWLINE_xXAlanine transaminase (ALT) or aspartate transaminase (AST) ? 2.5 x the upper limit of normal (ULN).Xx_NEWLINE_xXAST/ALT < 2.5 x ULNXx_NEWLINE_xXEither alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to Step 2 re-registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)Xx_NEWLINE_xXEither alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to Step 2 re-registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)Xx_NEWLINE_xXEither alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to step 2 re-registration (if both ALT and AST are done, both must be < 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)Xx_NEWLINE_xXIf the patient has liver metastases, ALT and AST < 5 x ULNXx_NEWLINE_xXAspartate aminotransferases (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN with the following exception:\r\n* Patients with liver involvement: AST and/or ALT =< 5 x ULNXx_NEWLINE_xXPHASE II: AST (SGOT)/ALT (SGPT) =< 3 X institutional upper limit of normal (ULN) or =< 5 X ULN if the patient has liver metastasesXx_NEWLINE_xXPatients on Part C with ALL: SGPT (ALT) =< 225 U/L; for the purpose of this study, the ULN for SGPT is 45 U/LXx_NEWLINE_xXAlkaline 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 ULNXx_NEWLINE_xXSGOT (AST) and SGPT (ALT) > 3x institutional ULNXx_NEWLINE_xXPHASE II: AST (SGOT) and ALT (SGPT) =< 3 times institutional ULN (=< 5 times if LFT elevations due to known liver metastases)Xx_NEWLINE_xXSubjects must have adequate organ and marrow function as defined below:\n\n               1. hemoglobin ?9.0 g/dL (?5.6 mmol/L)\n\n               2. white blood cells ?3,000/mm³(?3×10?/L)\n\n               3. absolute neutrophil count ?1,500/mm³ (?1.5×10?/L)\n\n               4. platelets ?100,000/?L (?100×10?/L)\n\n               5. total bilirubin ?1.5× upper limit of normal(ULN)\n\n               6. AST/ALT/AP ?2.5× ULN (ALT/AST ?5.0x ULN in case of documented liver metastases\n\n               7. creatinine ?1.5× ULN\n\n               8. albumin ?3.0 g/dL (?30 g/L)\n\n               9. INR ?1.4Xx_NEWLINE_xXBaseline alanine transaminase (ALT) or aspartate transaminase (AST) > 2 x upper limit of normal (ULN) without known complications of metastatic liver disease or primary hepatic disease (e.g. Cushing’s disease and acromegaly studies)Xx_NEWLINE_xXAST/ALT =< 2.5 x ULNXx_NEWLINE_xXAspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALK PHOS) must be within the range of eligibility as noted below:\r\n* AST or ALT =< 5 x ULN and ALK PHOS =< ULN\r\n* AST or ALT =< 1.5 x ULN and ALK PHOS =< 2.5 x ULN\r\n* AST or ALT =< ULN and ALK PHOS =< 5 x ULNXx_NEWLINE_xXPT ?1.5 ULNXx_NEWLINE_xXPTT ?1.5 ULNXx_NEWLINE_xXALT or AST <3 x ULNXx_NEWLINE_xXSerum aspartate transaminase (AST) and/or alanine transaminase (ALT) ?2.5×ULN.Xx_NEWLINE_xXSubject has adequate liver function, which is defined as: • Total bilirubin is ? 2 mg/dL unless the increase in bilirubin is attributable to Gilbert's Syndrome • AST is ? 3.0 x upper normal limit (ULN) for age. For the purpose of this study, the ULN for AST is 50 U/L. • ALT is ? 3.0 x upper normal limit (ULN) for age. For the purpose of this study, the ULN for ALT is 45 U/L.Xx_NEWLINE_xXSubjects must have adequate hepatic function as evidenced by: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ?3.0 × ULN, unless considered due to leukemic disease and serum total bilirubin ?1.5 x upper limit of normal (ULN), unless considered due to Gilbert's disease or leukemic diseaseXx_NEWLINE_xXAlanine transaminase (ALT) < 2.5 times the ULNXx_NEWLINE_xXTotal serum bilirubin ? 1.5 x ULN unless the patient has documented Gilbert syndrome and AST and ALT ? 2.5 x ULN.Xx_NEWLINE_xXSubjects who have BOTH bilirubin greater than ULN and AST/ALT greater than 1.0 x ULN are not eligibleXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 times upper limit of normal (ULN) or =< 5.0 times the ULN in the setting of liver metastasesXx_NEWLINE_xXPatient must have adequate hepatic function as evidenced by: Serum total bilirubin ?1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease or disease involvement; Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ?2.5 × ULN. For patients with bone metastases and/or suspected disease-related liver or biliary involvement, AST, ALT and ALP must be ?5 × ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN, or =< 5 x ULN if liver metastases are presentXx_NEWLINE_xXSerum AST/SGOT and ALT/SGPT ? 3.0 x ULN.Xx_NEWLINE_xXSerum AST and ALT/SGPT ? 3.0 x ULN.Xx_NEWLINE_xXAdequate liver function, defined as normal total bilirubin, ALT ?2.0x ULN, and AST ?2.0x ULN measured within 24 hours prior to crenolanib commencementXx_NEWLINE_xXAST and/or ALT ?5.0 x upper limit of normal (ULN) if liver metastases, or ?3 x ULN without liver metastasesXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x upper limit of normal (ULN) for the institutionXx_NEWLINE_xXAST(SGOT) and ALT(SGPT) <2.5 x ULNXx_NEWLINE_xXInadequate organ function immediate prior to randomization including: Hemoglobin <10g/dL (100g/L); ANC < 2000/mm³ (< 2.0 x 109/L); Platelets <100,000/mm³ (< 100 x 109/L); AST or ALT >1.5 x upper limit of normal (ULN); alkaline phosphatase > 2.5 x ULN, total serum bilirubin > 1.25 x ULN; serum creatinine >1.25 x ULN or estimated creatinine clearance < 60 mL/min as calculated using the method standard for the institution; severe and relevant co-morbidity that would interact with the participation in the studyXx_NEWLINE_xXS. Creat. > 1.5 x ULN.Xx_NEWLINE_xXEither alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to RE-TREATMENT registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)Xx_NEWLINE_xXAlkaline 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.Xx_NEWLINE_xXHepatic: Aspartate transaminase (AST) / Alanine transaminase (ALT) ? 2.5 x upper limit of normal (ULN) (if liver metastases are present, ? 5 x ULN); Total or conjugated bilirubin ? 1.5 x ULNXx_NEWLINE_xXALT/AST less than or equal to 3 times ULN or less than or equal to 5 times ULN in the setting of liver metastases.Xx_NEWLINE_xXPT <1.5 ULNXx_NEWLINE_xXPTT <1.5 ULNXx_NEWLINE_xXAST <3 × ULNXx_NEWLINE_xXSGOT (AST) ? 3 x ULNXx_NEWLINE_xXMF PATIENTS: ALT/AST =< 2.5 x ULNXx_NEWLINE_xXAST/ALT =< 2.5 x ULN if with liver metastasesXx_NEWLINE_xXScreening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ? 2.5 x upper limit of normal (ULN), total bilirubin ? 1.5 x ULN, creatinine ? 2.0 x ULN.Xx_NEWLINE_xXHepatic function: Conjugated bilirubin <1.5 × ULN and ALT and AST <3 × ULNXx_NEWLINE_xXAdequate liver function as assessed by total bilirubin ? 1.5x upper limit of normal (ULN), and alanine transaminase (ALT) and aspartate transaminase (AST) ? 2.5x ULN (? 5.0x ULN in the case of liver metastases). Patients with known Gilbert's syndrome may be enrolled with total bilirubin ? 3.0 mg/dL.Xx_NEWLINE_xXSUB-PROTOCOL AIM A: Aspartate transaminase (AST); alanine aminotransferase (ALT) =< 1.5 x ULN; NOTE: if subject has tumor involvement in the liver =< 5 X ULNXx_NEWLINE_xXAspartate transaminase (AST) < 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ? 2.5 × ULN.Xx_NEWLINE_xXPatients who do not have hepatocellular carcinoma but who have liver lesions or liver metastases may be eligible if they have AST < 3.5 x ULN and AST < 3.5 x ULN if agreed upon by the investigator and medical monitor for the sponsor.Xx_NEWLINE_xXPatients with hepatocellular carcinoma may be eligible provided they have AST and ALT that are ? 5.0 x ULN.Xx_NEWLINE_xXAST/ALT =< 2.5 x ULN and bilirubin =< ULN for patients with liver metastasesXx_NEWLINE_xXPatients with Gilbert syndrome and bilirubin < 2 x ULN and normal AST/ALTXx_NEWLINE_xXAlanine transaminase (ALT) at least 2.5 ULNXx_NEWLINE_xXAST (SGOT) and ALT (SGPT) <2 X institutional ULN (for subjects with hepatic metastases <5 X institutional ULN)Xx_NEWLINE_xXAspartate transaminase (AST) level ? 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ? 2.5 × upper limit of normal (ULN). For patients with liver metastases, AST ? 5 ULN, and AST ? 5 ULN may be enrolled if agreed upon by the investigator and medical monitor for the sponsor.Xx_NEWLINE_xXPatients must have adequate organ function: a) Bone marrow reserve: ANC ? 1.5 x 109/L, platelets ? 100 x 109/L, hemoglobin ? 9 g/dL b) Cardiac: i) QTcF < 450 msec on at least 2 of 3 screening ECGs. On site determination of QTcF may be used for screening purposes ii) LVEF equal to or greater than the institutional lower limit of normal. LVEF must be evaluated within 7 to 10 days prior to beginning study therapy iii) Cardiac Troponin I within normal limit (as per local institution) c) Hepatic: Total bilirubin ? 1.5 x ULN, ALT, AST ? 3.0 x ULN OR ? 5.0 x ULN for patients with liver metastases d) Renal: Serum/plasma creatinine ? 1.5 x ULN, or for patients with serum/plasma creatinine > 1.5 ULN, creatinine clearance ? 50 mL/min Exclusion Criteria for Part B: The presence of any of the following will exclude the patient from the study:Xx_NEWLINE_xXAlanine transaminase (ALT)/aspartate transaminase (AST) ? 2.5 x upper limit of normal (ULN).Xx_NEWLINE_xXAST (SGOT) and ALT (SGPT) ? 3.0 x ULNXx_NEWLINE_xXAST/SGOT and ALT/SGPT ? 3 x upper limit of normal (ULN) or ? 5.0 x ULN if liver tumor is present.Xx_NEWLINE_xXAST =< 5.0 x ULN or ALT =< 5.0 x ULN is acceptable if liver has tumor involvement; (Note, if both AST and ALT are done, both must be =< 5.0 x ULN)Xx_NEWLINE_xXHepatic: aspartate transaminase (AST) / alanine transaminase (ALT) ? 2.5 x upper limit of normal (ULN) (if liver metastases are present, ? 5 x ULN); total or conjugated bilirubin ? 1.5 x ULNXx_NEWLINE_xXScreening chemistry values of the following: alanine aminotransferase (ALT) and aspartate transaminase (AST) ? 3.0 × upper limit of the normal reference range (ULN), total bilirubin ? 2 × ULN, creatinine ? 1.5 × ULN, fasting blood glucose < 140 mg/dL, hemoglobin A1C ? ULN, albumin ? 2.8 g/dL.Xx_NEWLINE_xXAlkaline 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.Xx_NEWLINE_xXAST/SGOT and ALT/SGPT ?2.5×ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 3.0 x ULN for patients without liver metastases; for patients with liver metastasis ALT =< 5 x ULN is allowedXx_NEWLINE_xXALT (SGPT) ? 2.5 X ULN for ageXx_NEWLINE_xXAlanine transaminase (ALT) or aspartate transaminase (AST) =< 3 x ULN (if liver metastases are present, serum transaminases =< 5 x ULN are permitted)Xx_NEWLINE_xXALT and AST ?3 x ULN or ?5 x ULN if known hepatic metastases.Xx_NEWLINE_xXAST and/or ALT ?5.0 x upper limit of normal (ULN) if liver metastases, or ?3 x ULN without liver metastasesXx_NEWLINE_xXAST/SGOT and ALT/SGPT > 3.0 x ULNXx_NEWLINE_xXSerum aspartate transaminase (AST) or alanine transaminase (ALT) =< 3.0 x upper limit of normal (ULN); if considered related to ASM/MCL =< 5 x ULNXx_NEWLINE_xXAST (SGOT) and ALT (SGPT) ? 2.5 X ULN OR ? 5 X ULN for patients with liver metastasesXx_NEWLINE_xXAST and/or ALT >3 x ULNXx_NEWLINE_xXPatients with liver metastasis may not be included if AST and/or ALT >5 xULNXx_NEWLINE_xXAST/ALT ? 3 x ULN for patients without liver metastasis; ? 5 x ULN for patients with liver metastasisXx_NEWLINE_xXBilirubin =< 1.5 x ULN; for subjects with liver metastases =< 3 x ULN is allowedXx_NEWLINE_xXALT and AST less than or equal to 3 x ULNXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 times the ULN(or <= 5 times the ULN if liver metastases are present).Xx_NEWLINE_xXHepatic: Bilirubin 1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate transaminase (AST) 3.0 times ULN. For participants with tumor involvement of the liver, AST and ALT equaling ?5.0 times ULN are acceptable. Alkaline phosphatase ?5.0 times ULN for participants with tumor involvement of the bone is acceptable.Xx_NEWLINE_xXAspartate and alanine aminotransferases (AST, ALT) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN, if documented liver metastases are present)Xx_NEWLINE_xXAST and ALT ? 3 x ULN (? 5 x ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)Xx_NEWLINE_xXAbsolute neutrophil count ? 1,000/µL; platelets ? 75,000/µL; creatinine ? 1.5x upper limit of normal (ULN); total bilirubin ? 1.5x ULN; AST/ALT ? 2.5x ULN. For subjects with documented liver metastases, the AST/ALT may be ? 5x ULN.Xx_NEWLINE_xXAST/ALT ? 5X ULN [with underlying Liver Metastasis]Xx_NEWLINE_xXAspartate and alanine aminotransferases (AST, ALT) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN, if documented liver metastases are present)Xx_NEWLINE_xXParticipant has adequate hepatic function [bilirubin within normal limits (WNL), aspartate transaminase (AST) and alanine transaminase (ALT) ? 2.5 times the upper limit of normal (ULN), or ? 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase ? 5.0 times the ULN]Xx_NEWLINE_xXAST and ALT ? 3.0 x ULNXx_NEWLINE_xXAST and ALT =< 2.5 x ULN (=< 5 x ULN if liver metastases are present) obtained =< 7 days prior to registrationXx_NEWLINE_xXWithin 14 days of enrollment: Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 x ULN for the institution\r\n* For patients in the metastatic cohort with documented liver or bone metastases: AST and/or ALT =< 5.0 x ULNXx_NEWLINE_xXLiver Transaminases (ALT/AST) ? 2.5 x ULN, ? 5.0 x ULN if liver metastases presentXx_NEWLINE_xXAST and ALT ?2.5 × institutional ULN. Patients enrolled in an expansion stage may have ALT and AST <5 × institutional ULN if the patient has hepatic metastases.Xx_NEWLINE_xXSerum ALT/AST ? 2.5 x ULNXx_NEWLINE_xXALT > 3 x ULNXx_NEWLINE_xXAST > 3 x ULNXx_NEWLINE_xXAST, ALT must be <2 x ULN.Xx_NEWLINE_xXALT or AST > 2.5 ULN in patients (pts) without liver metastasis; for pts with liver metastasis: ALT or AST > 5 x ULNXx_NEWLINE_xXWithin 72 h of initiating study treatment: Alanine aminotransferase (ALT) =< 2.5 x ULN OR < 5 x ULN for liver metsXx_NEWLINE_xXAdequate bone marrow, hepatic, renal and coagulation function as defined by the following: Absolute neutrophil count ?1.5 x 10^9/L, Hemoglobin ?9.0 g/dL (90 g/L), Platelets ?100 x 10^9/L, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT ?5 x ULN, Bilirubin ?1.5 x ULN, Prothrombin time (PT) / international normalized ratio (INR) ?1.5 x ULN, Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equationXx_NEWLINE_xXAspartate transaminase (AST) and alanine aminotransferase (ALT) =< 1.5 x ULN (=< 5 x ULN for patients with liver involvement)Xx_NEWLINE_xXSerum transaminases activity =< 2.5 x ULN, with the exception of serum transaminases (< 3 x ULN) if the patient has liver metastasesXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 3.0 X ULN (=< 5.0 X ULN if liver metastases are present)Xx_NEWLINE_xXHepatic: Serum total bilirubin <=1.5 x upper limit of normal (ULN) (Patients with Gilbert's Disease may be included if their total bilirubin is <= 3.0 mg/dL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <= 2.5 x ULN. If the patient has known liver metastases, an ALT and/or AST <= 5 x ULN are allowed.Xx_NEWLINE_xXAST or ALT > 5 x ULNXx_NEWLINE_xXChronic liver disease (bilirubin > 1.5 x ULN, ALT or AST > 2 x ULN)Xx_NEWLINE_xXAdequate liver function: Alanine transaminase (ALT) < 2 x Upper Limit of Normal (ULN) and bilirubin < 1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). If liver metastases are present ALT must be < 5 x ULNXx_NEWLINE_xXAST/ALT: ? 2.5 x ULNXx_NEWLINE_xXAST or ALT ?2.5 x ULNXx_NEWLINE_xXAST/ALT ? 1.5 × ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) (obtained =< 7 days prior to randomization)Xx_NEWLINE_xXMajor Inclusion Criteria:\n\n          1. Signed written informed consent must be obtained and documented according to the\n             International Conference on Harmonisation (ICH) and be in accordance with local\n             regulatory requirements\n\n          2. A histologically confirmed hematologic malignancy that is advanced, relapsed, or\n             refractory to standard, currently available anti-cancer treatment options\n\n          3. ? 18 years of age\n\n          4. Eastern Cooperative Oncology Group (ECOG) performance status of ? 1 at dose escalation\n             phase and of ? 2 at dose expansion phase\n\n          5. Male or female patients of child-producing potential must agree to use contraception\n             or avoidance of pregnancy measures during the study and for 30 days after their last\n             dose\n\n          6. Females of childbearing potential must have a negative serum pregnancy test\n\n          7. Aspartate transaminase (AST) ? 2.5 x upper limit of normal (ULN) and alanine\n             transaminase (ALT) ? 2.5 × upper limit of normal (ULN). Patients whose disease\n             involves the liver and who have laboratory values of AST ? 3.5 ULN, AST ? 3.5 ULN, and\n             albumin ? 35g/L may be enrolled if agreed upon by the Principal Investigator and\n             Medical Monitor for the Sponsor\n\n          8. Total bilirubin < 1.5 x ULN, except for cases in which elevation of total bilirubin is\n             due to elevated levels of unconjugated bilirubin consistent with a diagnosis of\n             Gilbert's Syndrome\n\n          9. Life expectancy ? 3 monthsXx_NEWLINE_xXand alanine aminotransferase (ALT) ? 2.5 × ULN or ? 5 × ULN for subjects with known hepatic metastasesXx_NEWLINE_xXALT and AST ? 3.0 x ULN (subjects with known liver metastases may have AST and ALT ? 5.0 x ULN)Xx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 2.0 x ULNXx_NEWLINE_xXThe following criteria for evidence of adequate hepatic function performed within 4 weeks prior to study entry must be met: total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be must be less than or equal to 1.5 x ULN for the lab; and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab.Xx_NEWLINE_xXAspartate transaminase (AST) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN in patients with liver metastasis)Xx_NEWLINE_xXAST/ALT levels ? 2.5 x ULN, or ? 5 x ULN if liver metastases are present.Xx_NEWLINE_xXAlanine transaminase (ALT) =< 3 x ULN (=< 5 x ULN for patients with liver involvement)Xx_NEWLINE_xXAlanine aminotransferase (ALT) ? 1.5 x ULN unless there is hepatic involvement, then 3 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) < 2.5 times ULN; in the case of known (radiological and/or biopsy documented) liver metastasis, ALT < 5.0 times ULN is acceptableXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN for patients without liver metastases; for patients with liver metastasis ALT =< 5 x ULN is allowedXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) ? 3 x the upper limit of the normal range (ULN) (? 5 x ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)Xx_NEWLINE_xXAlanine transaminase (ALT) and aspartate transaminase (AST) =< 2.5 times the ULNXx_NEWLINE_xXHepatic: Serum total bilirubin ?2.5 x upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) ?2.5 x ULN.Xx_NEWLINE_xXAST level ?2.5 x ULN and ALT ? 2.5 × ULN. For patients with liver metastases, AST ?3.5 x ULN, and AST ?3.5 x ULN may be enrolled if agreed upon by the investigator and medical monitor for the sponsor.Xx_NEWLINE_xXAST (SGOT) and ALT (SGPT) ? 3.0 x ULN); if liver metastases are present, then ? 5 x ULN is allowedXx_NEWLINE_xXCOHORT B: AST/ALT =< 2.5 x ULNXx_NEWLINE_xXThe aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must not be more than 2.5 x ULN within 72 hours prior to enrollment, or greater than 5.0 X ULN if in the Investigator’s judgment it is related to liver metastases; AST and ALT may be up to 5 x ULN within 72 hours prior to enrollment in participants with hepatic metastasesXx_NEWLINE_xXThe following criteria for evidence of adequate hepatic function performed within 4 weeks prior to study entry must be met: Total bilirubin must be less than or equal to 1.5 x upper limit of normal (ULN); aspartate aminotransferase (AST) and ALT must be less than or equal to 2.5 x ULN for the lab or less than or equal to 5 x ULN if liver metastasis;Xx_NEWLINE_xXAlanine amino transferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (tested within 14 days prior to registration)\r\n* Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN (upper limit of normal) are not permittedXx_NEWLINE_xXSubjects with inadequate liver (alanine aminotransferase [ALT]/serum glutamate pyruvate transaminase [SGPT] above 4 X upper limit of normal [ULN] or direct bilirubin 4 X ULN AND the lab abnormalities are felt to be due to underlying liver dysfunction)Xx_NEWLINE_xXAlanine amino transferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN (upper limit of normal); concomitant elevations in AST/ALT above 1.0 x ULN are not permittedXx_NEWLINE_xXBilirubin < 2 x ULN (or < 5 x ULN if liver is involved)Xx_NEWLINE_xXAdequate liver function, as evidenced by a serum bilirubin </=2x the ULN (except for patients with a confirmed diagnosis of Gilbert's Disease) and an ALT or AST </=3x the laboratory ULN.Xx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN, or =< 5 x ULN if liver metastases are presentXx_NEWLINE_xXAST and ALT < 2.5 x ULNXx_NEWLINE_xXAST/SGOT and ALT/SGPT =< 2.5 x upper limit of normal (ULN) if liver metastases are presentXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 1.5 × upper limit of normal (ULN)Xx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) ?1.5 × upper limit of normal(ULN), or ? 2.5 × ULN with metastatic liver disease.Xx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 × the upper limit of normal (ULN), or =< 5 × the ULN in the presence of known liver metastasesXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) ? 3 × ULN (? 5 x ULN for subjects with liver metastases)Xx_NEWLINE_xXAdequate clinical laboratory values (i.e., plasma creatinine <= 1.5 x upper limit of normal (ULN) for the institution, bilirubin <=1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 x ULN).Xx_NEWLINE_xXAdequate liver function, defined as bilirubin ?1.5x ULN, ALT ?3.0x ULN, and AST ?3.0x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN or =< 5 x ULN if liver metastases persistXx_NEWLINE_xXALT =< 2.5 x =< 5 x ULN if liver metastases persistXx_NEWLINE_xXThe patient has serum total bilirubin < 2 g/dL (unless the patient has a diagnosis of Gilbert's disease), SGOT (ALT) <3.5×ULN, and SGPT (AST) <3.5×ULNXx_NEWLINE_xXAST and ALT no greater than 1.5 times ULNXx_NEWLINE_xXAST (SGOT) and ALT (SGPT) < = 3 x ULN.Xx_NEWLINE_xXAspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULN; unless elevated secondary to lymphoma involvement of the liverXx_NEWLINE_xXSubjects who have both bilirubin > ULN and AST/ALT > ULNXx_NEWLINE_xXSubjects with severe hepatic impairment\r\n* Bilirubin > 3 x ULN, regardless of any level of ALTXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x upper limits of normal (ULN)Xx_NEWLINE_xXConcomitant elevations in bilirubin and AST/ALT above 1.0 x ULN not permittedXx_NEWLINE_xXFor subjects with liver metastases: ALT and AST =< 5 x ULNXx_NEWLINE_xXException for patients with liver metastasis: ALT (SGPT) =< 8 x ULNXx_NEWLINE_xXALT<2x ULNXx_NEWLINE_xXAST and ALT ? 3 ULN (? 5 x ULN for subjects with liver metastases)Xx_NEWLINE_xXAdequate hepatic function, defined as total bilirubin ?1.5 × upper limit of normal (ULN); AST ?2.5 × ULN; and ALT ?2.5 × ULN. For subjects with documented metastatic disease to the liver, AST and ALT: ?5 × ULN.Xx_NEWLINE_xXAdequate hepatic function, defined as total bilirubin ?1.5 × ULN; AST ?2.5 × ULN; and ALT ?2.5 × ULN.Xx_NEWLINE_xXAspartate aminotransferase (AST) ?2.5 x ULN; ALT ?2.5 x ULN or AST/ALT <5 x ULN if liver involvementXx_NEWLINE_xXAlanine aminotransferase (ALT) ? 2.5 × ULN or ? 5 × ULN for subjects with known hepatic metastasesXx_NEWLINE_xXAST and ALT ? 2 x ULNXx_NEWLINE_xXAST/ALT < 3.0 x ULNXx_NEWLINE_xXAST/ALT < 3.0 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2 x upper limit of normal (ULN) or =< 5 x ULN if liver metastases presentXx_NEWLINE_xXPRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: AST/ALT < 3.0 x ULNXx_NEWLINE_xXALT or AST > 3.5 x ULN at screeningXx_NEWLINE_xXAST and ALT must be ? 5 x Upper Limit of Normal (ULN) if this elevation is solely due to ASM/MCL, otherwise AST, ALT must be ? 2.5 x ULNXx_NEWLINE_xX1.5 x ULNXx_NEWLINE_xXAlkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN eligibleXx_NEWLINE_xXAlkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN ineligibleXx_NEWLINE_xXAlkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN ineligibleXx_NEWLINE_xXAlkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN ineligibleXx_NEWLINE_xXAST and ALT ? 3.0 x ULN or ? 5 x ULN if subject has documented liver metastasesXx_NEWLINE_xXAspartate transaminase (AST) and alanine aminotransferase (ALT) ? 2.5 x upper limit of normal (ULN); or ? 5.0 × ULN if liver metastases are present.Xx_NEWLINE_xXSerum AST and ALT ? 3 x ULN;Xx_NEWLINE_xXAdequate hepatic function (total bilirubin ? 1.5x ULN for the institution; AST [aspartate transaminase] and ALT [alanine transaminase] ? 3x ULN).Xx_NEWLINE_xXALT ? 5x ULN of normal for age.Xx_NEWLINE_xXPatients with ALT > 10x ULN at screening.Xx_NEWLINE_xXAST and ALT 3.0 ULN with the following exception: Patients with liver involvement: AST and/or ALT 5 ULNXx_NEWLINE_xXAdequate hepatic function (total bilirubin ? 1.5×ULN for the institution; aspartate transaminase and alanine transaminase ? 2.5×ULN, or ? 5×ULN if due to liver involvement by tumor; albumin ? 3 g/dL)Xx_NEWLINE_xXHepatic: Total bilirubin ? 1.25 x upper limit of normal (ULN) (Arm: idelalisib + nab-paclitaxel ); total bilirubin ?1.5 x ULN (Arm: single agent idelalisib and Arm: idelalisib + mFOLFOX6); aspartate transaminase (AST) (SGOT), alanine transaminase (ALT) (SGPT) < 2.5 x ULN, and albumin > 3.0 g/dLXx_NEWLINE_xXSubjects must have adequate liver function assessed by: total bilirubin <= 1.0 x upper limit of normal (ULN), aspartate aminotransferase (ALT) <= 3.0 x ULN (CTCAE Grade <=1) or, if receiving BAY1143269 in combination with IV docetaxel, AST and ALT <=1.5 x ULN if concomitant with alkaline phosphatase increase >2.5 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 x ULN in pts without liver metastasis; for pts with liver metastasis: ALT or AST > 2.5 x ULNXx_NEWLINE_xXAdequate hepatic function (total bilirubin ? 1.5x ULN; AST and ALT ? 3x ULN).Xx_NEWLINE_xXFor Cohorts 1 and 2: serum aspartate transaminase (AST) or alanine transaminase (ALT) ?3.0 x upper limit of normal (ULN); for Cohort 3: ALT ?2.5 or AST ?2.5 ULN.Xx_NEWLINE_xXHepatic function: Total bilirubin < 1.5 × upper limit of normal (ULN) (except in the case of subjects with known Gilbert's disease: < 5 × ULN) and transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) < 3 × ULN based on age- and institution specific laboratory-specific normal rangesXx_NEWLINE_xXAST and/or ALT >= 3 times the ULNXx_NEWLINE_xXAST (SGOT), ALT (SGPT) ? 5 × ULN is allowed:Xx_NEWLINE_xXHepatic: Total conjugated bilirubin ? 1.25 x upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x upper limit of normal (ULN) or < 5 x ULN in the setting of liver metastasesXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN (=< 5.0 x ULN if considered due to leukemic involvement)Xx_NEWLINE_xXAST (SGOT) ? 3 × the ULN;Xx_NEWLINE_xXALT (SGPT) ? 3 × the ULN;Xx_NEWLINE_xXHepatic: Total bilirubin < upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ? 3 x ULNXx_NEWLINE_xXFor patients with tumor involvement of the liver AST or ALT > 5 x ULNXx_NEWLINE_xXAST(SGOT)/ALT(SGPT) =< 2.5 X institutional ULNXx_NEWLINE_xXTotal bilirubin ? 1.25 x upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ? 3 x ULNXx_NEWLINE_xXAST/ALT (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x --ULN in the presence of liver metastasesXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x ULN for the institutionXx_NEWLINE_xXAspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULNXx_NEWLINE_xX14. Adequate hepatic function (total bilirubin ? 1.5 x ULN for the institution; aspartate transaminase [AST] and alanine transaminase [ALT] ? 2.5 x ULN).Xx_NEWLINE_xXLiver enzymes [aspartate transaminase (AST), alanine transaminase (ALT)] ?2 x ULNXx_NEWLINE_xXAdequate hepatic function (total bilirubin ? 1.5x ULN (upper limit of normal) for the institution; AST [aspartate transaminase] and ALT [alanine transaminase] ? 3x ULN, or ? 5x ULN if due to liver involvement by tumor).Xx_NEWLINE_xXSerum AST or ALT ? 1.2 x ULNXx_NEWLINE_xXAspartate aminotransferase (AST) and alanine aminotransaminase (ALT) =< 3 x ULN for the institution (=< 5 x ULN is acceptable if liver has tumor involvement)Xx_NEWLINE_xXAlanine aminotransferase ?3 × ULN for the reference lab (?5 × ULN for subjects with known hepatic metastases)Xx_NEWLINE_xXSELUMETINIB ARM: AST/SGOT or ALT/SGPT > 2.5 x ULN (>= 5 ULN in presence of liver metastases)Xx_NEWLINE_xXBilirubin =< 1.5 mg/dL AND alkaline phosphatase =< 3 x the upper limit of normal (ULN) for the reference lab (=< 5x the ULN for patients with known hepatic metastases and no limit for patients with known bone metastases) AND aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3x the ULN ( =< 5x the ULN for patients with known hepatic metastases)Xx_NEWLINE_xXSerum alanine transaminase (ALT) >2.5x ULNXx_NEWLINE_xXSerum ALT/AST <2.5 ULNXx_NEWLINE_xXPatients with AST/ALT > ULN must have negative hepatitis studiesXx_NEWLINE_xXALT and AST ? 2.5 upper limit normal (ULN), or < 5 x ULN if liver metastases are present; serum total bilirubin ? ULN or 1.5 x ULN if liver metastases are present or total 3 x ULN with direct bilirubin ? ULN in patients with well documented Gilbert Syndrome.Xx_NEWLINE_xXAspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN), or AST or ALT greater than 5 times the ULN for those with Gilbert syndrome.Xx_NEWLINE_xXAST and ALT < 10 x ULN AND decreasing at two timepoints if patient is status/post (s/p) biliary stentingXx_NEWLINE_xXAdequate hepatic function: AST and ALT <2.5 x ULN, Total and Direct Bilirubin <1.5 x ULN. However, in the presence of liver metastases, AST and ALT must be <5 x ULNXx_NEWLINE_xXHave adequate marrow and organ function as defined in Table 2. Table 2 Laboratory Values SYSTEM LABORATORY VALUES Hematologic ANC ?1.5 x 109/L Hemoglobin ?9 g/dL (after transfusion if needed) Platelets ?100 x 109/L Hepatic Albumin ?2.5 g/dL Serum bilirubin ?1.5 x ULN unless due to Gilbert's syndrome AST and ALT ?3 x ULN Renal Calculated creatinine clearance* ? 40 mL/min Serum Creatinine ?1.5 mg/dL or 132.6?mol/L *Calculated by the Cockcroft-Gault Equation (Refer to protocol for details) Abbreviations: ANC, absolute neutrophil count; ULN, upper limit of normal; AST, aspartate aminotransferase; ALT, alanine aminotransferaseXx_NEWLINE_xXHepatic function: total bilirubin ? 1.5 x ULN; ALT and AST ? 3 x ULN; alkaline phosphatase ? 2.5 x ULNXx_NEWLINE_xXAST or ALT > 2.5 × ULN. For patients with liver metastasis, AST or ALT > 5 × ULNXx_NEWLINE_xXALT and AST ? 2.0 x ULNXx_NEWLINE_xXTransaminases =< 2 x ULN, except in known hepatic disease, wherein may be =< 5 x ULNXx_NEWLINE_xXParticipants with normal major organ functions as defined by hemoglobin (HgB) >= 8.5 gram/decilitre (dL), absolute neutrophil count (ANC) >= 1000/microliter (mcL), platelet >= 60,000/micL, aspartate aminotransferase/alanine transaminase (AST/ALT) <= 3 x Upper Limit of Normal (ULN), total Bilirubin <= 2 x ULN, creatinine <= 2 x ULN.Xx_NEWLINE_xXSerum aspartate transaminase (AST) or alanine transaminase (ALT) 2.5 x upper limit of normal (ULN) if no demonstrable liver metastases or 5 x ULN in the presence of liver metastasesXx_NEWLINE_xXAST and ALT ?2.5 x ULN for subjects without liver metastases and ?3.5 x ULN for subjects with liver metastasesXx_NEWLINE_xXHepatic: Aspartate transaminase (AST) / Alanine transaminase (ALT) ? 2.5 x upper limit of normal (ULN) (if liver metastases are present, ? 5 x ULN); Total or conjugated bilirubin ? 1.5 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) < 2.5 times ULN; in the case of known (radiological and/or biopsy documented) liver metastasis, ALT < 5.0 times ULN is acceptableXx_NEWLINE_xXAST/SGOT and/or ALT/SGPT > 2.5 x ULN, (> 5 x ULN if liver metastases present)Xx_NEWLINE_xXAdequate hepatic function as evidenced by: serum total bilirubin ?1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease, a gene mutation in UGT1A1, or disease involvement, following approval by the Medical Monitor; AST, ALT, ALP ?2.5 × ULN, with the exception of subjects with bone metastases and/or suspected disease-related liver or biliary involvement, where ALP must be ?5 × ULNXx_NEWLINE_xXAST and ALT ? 2.5 X ULNXx_NEWLINE_xXALT and AST > 2.5×ULN. For patients with documented liver metastases, ALT and AST > 5×ULN.Xx_NEWLINE_xXSerum total bilirubin ? 1.5 x ULN and AST/SGOT and ALT/SGPT ? 2.5 x ULN or ? 5 x ULN if liver metastases are present.Xx_NEWLINE_xXaPTT ? 1.5 x ULNXx_NEWLINE_xXAlanine transaminase (ALT) ? 3 × institutional upper limit of normal (ULN) [? 5 × ULN in presence of liver metastases] within 14 days prior to randomization.Xx_NEWLINE_xX- Hepatic function: aspartate aminotransferase (AST)/ Alanine Amino Transferase (ALT) = 1.5 X Upper Limit of Normal (ULN) and bilirubin = ULN for patients without liver metastases. AST/ALT = 2.5 X ULN and bilirubin = ULN for patients with liver metastases. Patients with Gilbert syndrome and bilirubin < 2 X ULN and normal AST/ALT are eligibleXx_NEWLINE_xXALT and AST < 3 x ULN (unless attributed to leukemic involvement)Xx_NEWLINE_xXAdequate hepatic function: serum total bilirubin ? 2X greater than the upper limit of normal (ULN) (? 3X ULN in subjects with liver metastases), aspartate aminotransferase) AST) / alanine aminotransferase (AST) ? 2X the ULN for the local reference lab (? 5X the ULN for subjects with liver metastases)Xx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN; if liver metastases are present, =< 5 x ULNXx_NEWLINE_xXHas adequate hepatic function, defined as: AST/ALT <= 3 X ULN (if liver metastases are present, <= 5 X ULN) Bilirubin <= 1.5 X ULNXx_NEWLINE_xXLaboratory values: Screening serum creatinine >1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9g/dL.Xx_NEWLINE_xXHepatic: total bilirubin ? 1.5 X ULN, ALT and AST ? ULN;Xx_NEWLINE_xXPT/aPIT ? 1.5 x ULNXx_NEWLINE_xXAlanine aminotransferase and AST ? 2.5 × ULN; for subjects with hepatic metastases, ALT and AST ? 5 × ULNXx_NEWLINE_xXAlanine aminotransferase (ALT)? 3 x upper limit of normal (ULN) or ? 5x ULN if liver metastasis is presentXx_NEWLINE_xXALP ? 3 x ULN or ? 5 x ULN if bone metastasis is presentXx_NEWLINE_xXAdequate hepatic function including ALT ? 2.5 x upper limit of normal (ULN) if liver metastasis is NOT present or ? 5 x ULN if liver metastasis is present, and total bilirubin ? 1.5 x ULN.Xx_NEWLINE_xXSerum Bilirubin ? ULN, AST and ALT ? ULNXx_NEWLINE_xXHepatic: Direct bilirubin ?1.5 X ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ? 2.5 X ULN. For patients with known liver metastases or liver neoplasms, then ALT or AST ? 5.0 X ULN is allowedXx_NEWLINE_xXAspartate aminotransferase (AST)/Alanine transferase (ALT) (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastasesXx_NEWLINE_xXHave adequate baseline organ function defined by the following criteria: Total bilirubin <=1.5 x upper limit of normal (ULN) except for Gilbert's syndrome, or other conditions that are not indicative of inadequate liver function (i.e. elevation of indirect bilirubin (haemolytic) in the absence of alanine aminotransferase [ALT] abnormality). ALT <=3 x ULN. Serum Creatinine <=2.5 x ULN.Xx_NEWLINE_xXMust have adequate organ function as defined by the following baseline values: Absolute neutrophil count >=1.5 x 10^9/Liter, Hemoglobin >=9 gram (g)/decilitre(dL), Platelets >=100 x 10^9/L, Partial thromboplastin time (PTT) <=1.25 x upper limit of normal (ULN), Albumin >=2.5 g/dL, Serum total bilirubin <=1.25 times ULN (for Arm B: <=ULN ), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <=2.5 times ULN (for Arm B: <=1.5 times ULN), Serum Creatinine <=1.5 x ULN, Or Measured or Calculated Creatinine Clearance >=45 mL/min (Arm A or B), >=65 mL/min (Arm C), Left ventricular ejection fraction >=50% by ECHO.Xx_NEWLINE_xXPart 1 only: plasma total bilirubin <= 1.5 mg/dL, alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 X ULN.Xx_NEWLINE_xXTotal bilirubin ? ULN, SGOT (AST) and SGPT (ALT)< 1.5 x ULN. AST and/or ALT may be up to 5X ULN if with known liver metastases provided bilirubin is normal.Xx_NEWLINE_xXAST and ALT ? 3 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ? 5 x ULN.Xx_NEWLINE_xXAST or ALT > 3× the ULN for the institution (> 5× ULN if due to hepatic involvement by tumor)Xx_NEWLINE_xXAlanine Transaminase (ALT) and Aspartate Transaminase (AST) ? 2.5 x ULN (if liver metastases are present, then ? 5 x ULN is allowed)Xx_NEWLINE_xXAST(SGOT)/ALT(SGPT) <2.5 X institutional ULN unless due to diseaseXx_NEWLINE_xXSGPT (ALT) ? 135 U/L and SGOT (AST) ? 3X ULN. (for the purpose of this study, the upper limit of normal [ULN] for SGPT [ALT] is 45 U/L).Xx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 × the upper limit of normal (ULN)Xx_NEWLINE_xXAdequate liver function defined as: bilirubin (sum of conjugated + unconjugated) <=1.5 x upper limit of normal (ULN) for age, aspartate aminotransaminase (AST) and alanine transaminase (ALT) <=2.5 x ULN; AST/ALT may be <5 x ULN at baseline if disease under treatment involves the liver (requires radiographic confirmation of liver involvement).Xx_NEWLINE_xXAlanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) each < 3 x the upper limit of normal (ULN); however, ALT, AST, and TBILI each ? 5 x ULN is acceptable if the elevation is considered by the investigator to be due to PTLD involvement of the liverXx_NEWLINE_xXALT or AST < 2.5 X ULN in the absence of liver metastasesXx_NEWLINE_xXAST & ALT ? 2.5 x ULNXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) ?3 × ULNXx_NEWLINE_xXElevated liver function tests (LFTs): Serum bilirubin >upper limit of normal (ULN), alanine (ALT) or aspartate (AST) aminotransferase > 1.5 ULN concomitant with alkaline phosphatase > 2.5 ULNXx_NEWLINE_xXAspartate transaminase (AST) or alanine transaminase (ALT) ?3 x ULN, unless considered due to organ leukemic involvementXx_NEWLINE_xXAdequate hepatic function, defined as AST and ALT ?3.0X ULN and serum direct bilirubin ?1.5X ULN. Exceptions may be made for patients with elevated liver transaminases secondary to AML after discussion with the Medical MonitorXx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN or =< 5 x ULN if liver metastases persistXx_NEWLINE_xXAlkaline 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.Xx_NEWLINE_xXAspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALK PHOS) must be within the range allowing for eligibility:\r\n* ALK PHOS =< ULN AND AST or ALT =< 1.5 X ULN\r\n* ALK PHOS > 1 X ULN but =< 2.5 ULN AND AST or ALT =< 1.5 X ULN\r\n* ALK PHOS > 2.5 X ULN but =< 5 X ULN AND AST or ALT =< ULNXx_NEWLINE_xXPatients 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.Xx_NEWLINE_xXHepatic function: Serum total bilirubin ? 1.5 x ULN (upper limit of normal); AST (SGOT) and ALT (SGPT) ? 3 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ? 5 x ULNXx_NEWLINE_xXALT or AST 3xULN and bilirubin 2xULNXx_NEWLINE_xXHepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), ALT, and aspartate transferase (AST) less than or equal to 2.0 times ULN. If the liver has tumor involvement AST and ALT equaling less than or equal to 5 times ULN are acceptable.Xx_NEWLINE_xXALT and/or AST ?2.5 X ULNXx_NEWLINE_xXALT and/or AST ?2.5X ULNXx_NEWLINE_xXALT and/or AST ?3X ULNXx_NEWLINE_xXALT and/or AST ?3X ULNXx_NEWLINE_xXALT or AST > 3 x ULNXx_NEWLINE_xXSerum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and alkaline phosphatase (AP) must be within the range allowing for eligibility:\r\n* AP =< upper limit of normal (ULN) AND AST or ALT > 1 x ULN, but =< 1.5 x ULN\r\n* AP > 1 x ULN, but =< 2.5 x ULN AND AST or ALT > 1 x ULN, but =< 1.5 x ULN\r\n* AP > 2.5 x ULN, but =< 5 x ULN AND AST or ALT =< ULN\r\n* AP > 5 x ULN not eligibleXx_NEWLINE_xXAdequate laboratory values. a) Hemoglobin >/=10 gm/dL. b) White blood cell count (WBC) >/= 3000/µL. c) Absolute neutrophil count (ANC) >/= 1500/µL. d) Platelet count >/=100,000/µL. e) PT </= 1.5 x upper limit of normal (ULN). f) Activated partial thromboplastin time (aPTT) </= 1.5 x ULN. g) AST </=1.5 x ULN. h) ALT </= 1.5 x ULN. i) Total bilirubin </= 1.5 x ULN. j) Creatinine </=1.5 x ULN.Xx_NEWLINE_xXSerum ALT < 2.5 times the ULN.Xx_NEWLINE_xXLiver Function If bilirubin, AST, and/or ALT are >ULNXx_NEWLINE_xXAST and ALT =< 2.5 x ULNXx_NEWLINE_xXAST and ALT < 2.5 x ULNXx_NEWLINE_xXAST, ALT, and alkaline phosphatase (AP) must meet one of the following criteria:\r\n* AST or ALT =< 5 times ULN AND AP =< normal\r\n* AST or ALT =< 1.5 times ULN AND AP =< 2.5 times ULN\r\n* AST or ALT =< normal AND AP =< 5 times ULNXx_NEWLINE_xXThe participant has adequate hepatic function as defined by a total bilirubin ? 1.5 x the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT) ? 3 x the ULN (or ? 5 x the ULN in the presence of known liver metastases)Xx_NEWLINE_xXAlanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x ULN; in patients with significant liver disease and chronically elevated liver transaminases, ALT may be elevated as high as 8 x ULNXx_NEWLINE_xXAST or ALT < 1.5 times ULN for ageXx_NEWLINE_xXAspartate transaminase (AST) > 3.0 x ULN, except for patients with liver metastasis who are excluded if AST > 5.0 x ULNXx_NEWLINE_xXAlanine transaminase (ALT) > 3.0 x ULN, except for patients with liver metastasis who are excluded if ALT > 5.0 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) < 2.5 times ULN; in the case of known (radiological and/or biopsy documented) liver metastasis, ALT < 5.0 times ULN is acceptable; patients with > 3 liver metastases at enrollment will be excludedXx_NEWLINE_xXAspartate transaminase (AST) =< 3 x ULN unless due to direct lymphoma involvement, and then =< 5x ULNXx_NEWLINE_xXALT and AST <2.5 × ULN or, in patients with documented hepatic metastasis, ?5.0 × ULN.Xx_NEWLINE_xXAST ? 2.5 times ULN (? 5 times ULN for patients with liver metastases);Xx_NEWLINE_xXAST/(SGOT)/ALT(SGPT) =< 3.0 x institutional upper limit of normal (ULN) (=< 5.0 x institutional ULN with documented liver metastases)Xx_NEWLINE_xXHepatic: total bilirubin less than or equal to (<=) 1.5*the upper limit of the normal range (ULN); alanine aminotransferase (ALT) and AST <=2.5*ULN.Xx_NEWLINE_xXAlkaline 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.Xx_NEWLINE_xXALT and AST ? 3.0 x ULN within 14 days prior to registrationXx_NEWLINE_xXAST, and ALT > 1.5 x ULNXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) levels =< 5 x upper limit of normal (ULN)Xx_NEWLINE_xXAspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULNXx_NEWLINE_xXAlanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)Xx_NEWLINE_xXSerum alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 × ULN;Xx_NEWLINE_xXBilirubin ? 2.0 mg/dl; AST and ALT < 5.0 times the ULNXx_NEWLINE_xXScreening chemistry values of the following: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ? 3.0 × upper limit of the normal (ULN), total bilirubin ? 1.5 × ULN, Creatinine ? 1.5 × ULN;Xx_NEWLINE_xXTotal bilirubin ?1.5 times upper limit of normal value (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ?5 × ULN.Xx_NEWLINE_xXAlanine transaminase (alanine aminotransferase [ALT]) =< 2 x upper normal limit (ULN) (in the expansion cohort, patients with known liver involvement may have ALT =< 5 x ULN); aspartate aminotransferase (AST) =< 2 x ULN (in the expansion cohort, patients with known liver involvement may have AST =< 5 x ULN)Xx_NEWLINE_xXPatients with underlying liver disease, such as cirrhosis or chronic hepatitis, and do not have primary or metastatic cancer in the liver will be excluded if alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN) or total bilirubin (bili) > 3 x ULN; in the presence of primary or metastatic liver cancer, patients will be excluded if ALT/AST > 5 x ULN or total bili > 5 x ULNXx_NEWLINE_xXAbnormal liver function (total bilirubin > 2X ULN or liver enzymes alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 2.5X ULN for subjects without liver metastasis or ? 5X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening. Subjects with documented Gilbert's Disease may be eligible.Xx_NEWLINE_xXAlanine transaminase (ALT) < 5.0 x ULNXx_NEWLINE_xXAlanine transaminase (ALT) =< 3 x ULNXx_NEWLINE_xXLiver dysfunction manifested by SGTP (ALT) > 5X Upper limit of normal (ULN) and/or Aspartate aminotransferase (AST) >5 X ULN and/or direct (conjugated) bilirubin > 2X ULNXx_NEWLINE_xXALT and AST ? 1.5 ULN of institution's rangeXx_NEWLINE_xXAspartate aminotransferase (AST) =< 2.5 x upper limit of normal range (ULN); for subjects with known liver metastases =< 5 x ULN, and alanine aminotransferase (ALT) =< 2.5 x ULN; for subjects with known liver metastases =< 5 x ULNXx_NEWLINE_xXSignificant liver disease as defined as aspartate transaminase (AST) or alanine transferase (ALT) twice than normalXx_NEWLINE_xXPatients with a history of liver disease or AST/ALT >= 2.5 times ULN on screeningXx_NEWLINE_xXAST > 2.5 x ULN (CTCAE grade 2)Xx_NEWLINE_xXAST (SGOT) and ALT (SGPT) ? 2.5 x ULN. For subjects with documented liver metastases, ALT and AST ? 5 × ULNXx_NEWLINE_xXPatients with abnormal liver function will be eligible and will be grouped according to the criteria below\r\n* Group A (normal hepatic function)\r\n** Bilirubin =< upper limit of normal (ULN) and aspartate aminotransferase (AST) =< ULN\r\n* Group B (mild hepatic dysfunction)\r\n** B1: bilirubin =< ULN and AST > ULN\r\n** B2: bilirubin > ULN but =< 1.5 x ULN and any AST\r\n* Group C (moderate hepatic dysfunction)\r\n** Bilirubin > 1.5 x ULN to =< 3 x ULN and any AST\r\n* Group D (severe hepatic dysfunction) \r\n** Bilirubin > 3 x ULN and up to investigators discretion and any AST\r\n* Patients with active hemolysis should be excluded; no distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes; registration laboratory investigations will be used to assign a patient to a hepatic function group; liver function tests should be repeated within 24 hours prior to starting initial therapy and may result in the patients' group assignment being altered if different to registration test resultsXx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) £1.5 × upper limit of normal (ULN), or ? 2.5 × ULN with metastatic liver diseaseXx_NEWLINE_xXObtained within 28 days prior to registration: Alanine aminotransferase (ALT) =< 2.5 x ULN (subjects with documented liver metastases should have ALT =< 5 x ULN)Xx_NEWLINE_xXAspartate transaminase (AST) and alanine transaminase (ALT) ? 2.5 x ULN for ageXx_NEWLINE_xXAlanine aminotransferase (ALT) < 3 × ULN unless hepatic metastases are present, then < 5 × ULNXx_NEWLINE_xX- AST and ALT < 2.5 x ULN (< 5 x ULN in patients with known liver metastases)Xx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN OR < 5 x ULN for subjects with liver metastases, obtained within 14 days prior to C11-AMT PET scanXx_NEWLINE_xXAST/SGOT, ALT/SGPT ?2.5 x ULN, unless liver metastases are clearly present, then ?5.0 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULN (evaluated within 28 days of randomization); concomitant elevations in bilirubin and aspartate amino transferase (AST)/alanine aminotransferase (ALT) above 1.0 x ULN are not permittedXx_NEWLINE_xXAST and ALT =< 2.5 X ULN or =< 5 x ULN if liver metastases are present (evaluated within 28 days of randomization); concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN are not permittedXx_NEWLINE_xXAbnormal liver functions consisting of any of the following:\r\n* Serum bilirubin >= 1.5 x ULN (except for patients with documented Gilbert’s disease)\r\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2.5 x ULN, (for patients with known liver metastasis, AST or ALT =< 5 x ULN is allowed)Xx_NEWLINE_xXALT/AST ? 2.5 x ULN or ? 5 x ULN if documented liver metastasesXx_NEWLINE_xXAST/ALT < 3.0 x ULNXx_NEWLINE_xXAST(SGOT)/ALT(SGPT) ?3 X ULN (including patients with liver metastases)Xx_NEWLINE_xXAlanine aminotransferase (ALT) =< 2.5 x ULN (=< 5.0 x in case of liver mets), within 2 weeks prior to study startXx_NEWLINE_xXALT > 1.5 x ULNXx_NEWLINE_xX- AST and ALT < 2.5 x ULN (< 5 x ULN in patients with known liver metastases)Xx_NEWLINE_xXHepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULNXx_NEWLINE_xXAspartate transaminase (AST) =< 3 x upper limit of normal (ULN) (=< 5 x ULN acceptable for pancreatic subjects with known liver metastasis only)Xx_NEWLINE_xXAlanine transaminase (ALT) =< 3 x ULN (=< 5 x ULN acceptable for pancreatic subjects with known liver metastasis only)Xx_NEWLINE_xXHave adequate organ function, including: Hepatic: Bilirubin ?1.5 × the upper limit of normal (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ?3.0 × ULN. For participants with tumor involvement of the liver, AST and ALT ?5.0 × ULN are acceptable. For participants with tumor involvement of the bone, alkaline phosphatase ?5.0 × ULN is acceptable. Renal: Serum creatinine ?2.0 × ULN. Absolute neutrophil count (ANC) ?1.0 × 109/liter (L). Hemoglobin ?9 grams per deciliter (5.58 millimoles per liter). Platelets ?90 × 109/L.Xx_NEWLINE_xXHepatic: bilirubin ?1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate transaminase (AST) ?3.0 times ULN. For participants with tumor involvement of the liver, AST and ALT equaling ?5.0 times ULN are acceptable. Alkaline phosphatase ?5.0 times ULN for participants with tumor involvement of the bone is acceptable.Xx_NEWLINE_xXAST and ALT ? 3.0 x ULN, independently of the presence of liver metastases.Xx_NEWLINE_xXAP ? 2.5 x ULN (? 5 x ULN if disease-related).Xx_NEWLINE_xXSGOT(AST) and SGPT(ALT) ? 3 x ULN i.e. equivalent to ? Grade 1 NCI-CTCAE v.4.03Xx_NEWLINE_xXCohort 3 (moderate): ? 1.6-3 × ULN; any ASTXx_NEWLINE_xXCohort 1 (normal hepatic function): Bilirubin ? ULN; AST ? ULNXx_NEWLINE_xXThe participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).Xx_NEWLINE_xXThe participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).Xx_NEWLINE_xXSerum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.0 x ULN or ? 5 X ULN for subjects with liver metastases.Xx_NEWLINE_xXAST ? 3.0 x ULNXx_NEWLINE_xXALT ? 3.0 x ULNXx_NEWLINE_xXAdequate 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 presentXx_NEWLINE_xX