Total bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled), within 2 weeks of randomizationXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 30 days of day 1 of study; NOTE: patients with elevated bilirubin secondary to Gilbert’s disease are eligible to participate in the studyXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for age, andXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert‘s syndrome who must have total bilirubin =< 3.0 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the institutional upper limit of normal (ULN), within 28 days prior to administration of study treatmentXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXWithin 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which bilirubin =< 3 x institutional ULN is permitted)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXWithin 28 days prior to registration: Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert’s disease, total bilirubin =< 3.0 x IULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert syndrome who must have a total bilirubin < 3.0 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x upper limit of normal [ULN] with Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (=< 3 mg/dL in case of Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 2.5 x institutional upper limit of normal (IULN) (except patients with Gilbert’s syndrome) within 28 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 X institutional ULN (if the patient has liver metastases)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) except in the case of Gilbert diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); unless patient has Gilbert diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< the upper limit of normal (ULN) within 4 weeks prior to randomizationXx_NEWLINE_xXWithin less than or equal to 14 days prior to registration: Total serum bilirubin =< institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for age, andXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXDirect bilirubin =< 3 x upper limit of normal (ULN) for age, andXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) unless isolated hyperbilirubinemia attributed to Gilbert’s syndromeXx_NEWLINE_xXTotal or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, andXx_NEWLINE_xXBilirubin =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXObtained within 28 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 3.0 x IULN with Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN), within 21 days prior to registrationXx_NEWLINE_xXTotal bilirubin < 2 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) within 28 days prior to step 1 registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) within 28 days prior to step 3 registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert’s syndromeXx_NEWLINE_xXRegistration Step 3 – Maintenance: Patients must have total bilirubin < 2.0 x institutional upper limit of normal (IULN) within 14 days prior to registrationXx_NEWLINE_xXBilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXBilirubin =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)Xx_NEWLINE_xXTotal bilirubin =< 5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXDirect bilirubin < 2.0 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x upper limit of normal (ULN) for age ANDXx_NEWLINE_xXTotal bilirubin =< 2.0 x upper limit of normal (ULN), within 14 days of registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN), measured within 28 days prior to administration of study treatmentXx_NEWLINE_xXTotal bilirubin < 1.5 X institutional upper limit of normal; for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal rangeXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), documented within 14 days of registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x upper limit of normal (ULN) for age ANDXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normalXx_NEWLINE_xXSerum total bilirubin =< 1.5X the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin (T. Bili) =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal for ageXx_NEWLINE_xXBilirubin =< 2.0 x upper limit of institutional normal valueXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s Syndrome must have bilirubin =< 3 x ULN (for treatment phase)Xx_NEWLINE_xXMeasured within 28 days prior to registration: total bilirubin =< 1.5 x institutional upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (< 2 × ULN) is allowed.Xx_NEWLINE_xXObtained =< 21 days prior to registration: Total Bilirubin =< 1.5 x upper limit of normal (ULN)\r\n* NOTE: For bilirubin elevation 1 to 1.5 x ULN, alanine aminotransferase (ALT) above 1.5 x ULN (upper limit of normal) is not permitted\r\n* NOTE: For bilirubin elevation 1 to 1.5 x ULN, aspartate aminotransferase (AST) above 1.5 x ULN (upper limit of normal) is not permittedXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (IULN)Xx_NEWLINE_xXBilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin level =< 1.5 x the upper limit of normal (ULN) rangeXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) (or < 3 x ULN for subjects with Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normalXx_NEWLINE_xXPatients with bilirubin =< 2 x upper limit of normalXx_NEWLINE_xXObtained =< 14 days prior to registration: Direct bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal Bilirubin ? 1.5 x upper limit of normal (ULN), or patients diagnosed with Gilberts syndrome, that have been reviewed and approved by the medical monitor.Xx_NEWLINE_xXTotal bilirubin within normal institutional limits (unless patient has Gilbert’s syndrome in which total bilirubin should be =< 2 x upper limit of normal [ULN])Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin < 2 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or 3 x ULN for Gilbert's diseaseXx_NEWLINE_xXTotal bilirubin at most1.5 x the upper limit of the normal range (ULN), except Gilbert's diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal rangeXx_NEWLINE_xXTotal bilirubin =< 1.5 x institution's upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 1.5 X upper limit of normal unless known diagnosis of Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) except patients with documented Gilbert’s syndrome (=< 3 x ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin concentration =< 1.5 x the institutional upper limit of normal for ageXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 × the upper limit of the normal range (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x upper limit of normal (ULN) or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndromeXx_NEWLINE_xXBilirubin =< 1.5 x laboratory normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal, unless due to Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin less than or equal to the institution's upper limit of normalXx_NEWLINE_xXSerum bilirubin < 1.5 x the upper limit of normal (ULN) or < 5 x the ULN if secondary to liver metastasisXx_NEWLINE_xXTotal bilirubin =< 1.25 x institutional upper limit of normal (ULN), with the exception of < 2.9 mg/dL for patients with Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin ?1.5 × the upper limit of normal (ULN) (subjects with Gilbert's Syndrome are allowed if direct bilirubin is within normal limits);Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL x the upper limit of normal (ULN), within 14 days before the first dose of cabozantinibXx_NEWLINE_xXTotal bilirubin less than 1.5 x upper normal limit (UNL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) OR serum direct bilirubin =< 2 x institutional ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 × upper limit of normal (ULN); bilirubin =< 3 x ULN is permitted in individuals with documented liver involvement by lymphoma or if due to known Gilbert syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal rangeXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless hepatic dysfunction is caused by cGVHD)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (or =< 2.5 x ULN for subjects with asymptomatic Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) or within 3 x the ULN for patients with Gilbert diseaseXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 2 X institutional upper limit of normal (ULN) (documented within 28 days of registration)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal rangeXx_NEWLINE_xXTotal bilirubin =< 1.3 mg/dl (institutional upper limit of normal)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTREATMENT: Bilirubin =< 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 x upper limit of normal (ULN)for age, andXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal obtained =< 14 days prior to registrationXx_NEWLINE_xXPatients with bilirubin =< 3 x normalXx_NEWLINE_xXTotal bilirubin =<1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXHave a serum total bilirubin ?1.5 × ULN (upper limit of normal).Xx_NEWLINE_xXSerum bilirubin ? 1.5 × upper limit of normal (ULN) or ? 2 x ULN if patient is known to have Gilbert’s disease as the only underlying hepatic disorderXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x institutional upper limit of normalXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (< 2 x ULN) is allowed.Xx_NEWLINE_xXSerum bilirubin < 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)\r\n* Note: Patients with Gilbert’s syndrome with a total bilirubin =< 2.0 times ULN and direct bilirubin within normal limits are permittedXx_NEWLINE_xXTotal bilirubin =< 1.25 x institutional upper limitXx_NEWLINE_xXTotal bilirubin ? 2 × the upper limit of the normal range (ULN)Xx_NEWLINE_xXDirect bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Total bilirubin =< 2 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXEXPANDED ACCESS COHORT: Total bilirubin =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 3.0 x ULN (upper limit of normal)Xx_NEWLINE_xXtotal bilirubin ? 1.5 institutional upper limit of normal [ULN])Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x upper limit of normal (ULN) OR if hepatic involvement by lymphoma: =< 3 x ULN for Gilbert's disease or documented hepatic involvement by lymphomaXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXPatients with bilirubin ? 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN), completed within 14 days prior to the date of registrationXx_NEWLINE_xXTotal bilirubin ? 1.5 x upper limit of institutional normal (ULN), unless due to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or 2.0 x ULN in patients with documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN), with exception of patients with Gilbert syndromeXx_NEWLINE_xXTotal bilirubin =< 1.2 X institutional upper limit of normal (ULN) OR =< 3.0 X institutional ULN if the patient has Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (IULN) or total bilirubin =< 3.0 x IULN with direct bilirubin within normal range in patients with documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin=< 1.5 x upper limit of normal (ULN) (if, however, the participant has Gilbert’s disease or unconjugated hyperbilirubinemia that is considered to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome or hemolysis, in which case =< 3.0 x ULN is allowedXx_NEWLINE_xXTotal bilirubin =< 1.5 within 30 days prior to registration\r\n* It is highly recommended but not required that total bilirubin be =< 1.5 upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN), within 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin within normal institutional limits (WLN) or =< 1.5 x upper limit of normal (ULN) in patients with liver metastases; or total bilirubin =< 3 x ULN with direct bilirubin WLN in patients with well documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), determined within 14 days of registrationXx_NEWLINE_xXSerum bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin (except for Gilbert’s syndrome) =< 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXAdequate hepatic function, with total bilirubin ?1.5 x upper limit of normal (ULN) (except for Gilbert Syndrome: total bilirubin < 3.0 x ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?3.0 x ULN.Xx_NEWLINE_xXWithin 28 days of study registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.2 x institutional upper limit of normal\r\n* With the exception of candidates with a diagnosis of Gilbert’s disease in which case the total bilirubin may extend up to 1.5 x institutional upper limit of normalXx_NEWLINE_xXObtained =< 35 days prior to registration: total or direct bilirubin < 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x institutional upper limit of normal (ULN) (or ? 2.5 x ULN with Gilbert’s disease) within 28 days prior to registrationXx_NEWLINE_xXBilirubin =< upper limit of institutional normalXx_NEWLINE_xXTotal bilirubin < 2 x upper normal limitXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to start of protocol therapy.Xx_NEWLINE_xXTotal serum bilirubin <1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 × upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institution’s upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X MSKCC upper limit of normalXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x upper limit of normal (ULN) (< 3 x ULN in patients with documented/suspected Gilbert’s disease with concomitant direct bilirubin =< 1.5 x ULN)Xx_NEWLINE_xXAdequate organ function within 14 days of study registration including:\r\n* Total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN); no prior history of Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 2.0 x institution’s upper limit of normal (ULN)Xx_NEWLINE_xXWithin 14 days prior to registration: Total bilirubin < 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin > 1.5 x the upper limit of normalXx_NEWLINE_xXTotal bilirubin ?2.0 x the upper limit of normal or <3.0 xULN if patient has a history of Gilbert's syndromeXx_NEWLINE_xXBilirubin ? 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin level =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin < 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 upper limit of normal (ULN), with the exception of patients with Gilbert syndromeXx_NEWLINE_xXTotal bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin >2.5 x ULN.Xx_NEWLINE_xXSerum bilirubin =< 2.0 x upper limit of institutional normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s disease; if total bilirubin is > 1.5 x ULN, a direct bilirubin should be performed and must be =< upper limit of normal (obtained =< 14 days prior to registration)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be =< ULN =< 28 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN) (except in the case of subjects with documented Gilbert’s disease >= 3 x ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x the upper limit of the normal range (ULN).Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) within four weeks of enrollmentXx_NEWLINE_xXTotal bilirubin: =< 3 X upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for age; participants with biliary or hepatic primaries with bilirubin values greater than 1.5 x ULN may be enrolled on study if all other eligibility criteria are metXx_NEWLINE_xXObtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXSerum total bilirubin: =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXSerum creatinine, total bilirubin, ALT/SGPT </= 2.0 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin > 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXBilirubin ? 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin level =< 1.5 x upper limit of normal (ULN) or in patients with Gilbert’s syndrome, a total bilirubin of =< 3.0Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (ULN) unless due to indirect hyperbilirubinemia related to Gilbert's syndrome or hemolysis, or to disease infiltrationXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) (except in Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum indirect bilirubin level =< 3 X ULN may be enrolled.Xx_NEWLINE_xXTotal bilirubin ? 1.5 x upper limit of normal (ULN) (Patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s disease), =< 5 days prior to C1D1Xx_NEWLINE_xXBilirubin =< 1.5 × upper limit of normal (ULN) obtained within 14 days prior to initiating study treatment.Xx_NEWLINE_xXTotal bilirubin level =< 1.5 × the upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin =< 3 X upper limit of normal (ULN), unless attributable to Gilbert syndromeXx_NEWLINE_xXTotal serum bilirubin < 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome, hemolysis or the underlying leukemia approved by the principal investigator (PI)Xx_NEWLINE_xXTotal bilirubin ? 2 x upper limit of normal (ULN) for ageXx_NEWLINE_xXObtained ? 14 days prior to registration: Total bilirubin ? 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin of =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXSerum bilirubin =< 2.0 × the upper limit of normal (ULN).Xx_NEWLINE_xXTotal Bilirubin ? 1.5 x upper limit of normal (ULN), or patients diagnosed with Gilbert's syndrome, that have been reviewed and approved by the medical monitorXx_NEWLINE_xXSerum bilirubin < 2 x upper limit of normal.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome, in which case the direct bilirubin must be =< 1.5 X ULN, obtained =< 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 × upper limit of normal (ULN) (unless indirect bilirubin is elevated due to Gilbert's syndrome or hemolysis)Xx_NEWLINE_xXTotal bilirubin =< 3 x upper limit of normal (ULN)Xx_NEWLINE_xXObtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (within 14 days of PET imaging)Xx_NEWLINE_xXTotal bilirubin level =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXWithin 28 days prior to registration: Bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 2 X upper limits of normal (ULN) (except in the case of subjects with documented Gilbert’s disease > 3 x ULN)Xx_NEWLINE_xXBilirubin < 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin less than or equal to 2.5 x the upper limit of normal (ULN) (excluding Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin level =< 1.5 x the upper limit of normal (ULN).Xx_NEWLINE_xXBilirubin < 1.5 x institutional upper limit of normal (ULN) or < 3 x ULN in patients with Gilbert's disease or liver involvementXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN).Xx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin ? 3 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXAdequate hepatic function including total bilirubin < 2 x upper limit of normal (ULN) unless increase is due to Gilbert’s disease or leukemic involvementXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limitXx_NEWLINE_xXSTUDY TREATMENT: Total bilirubin =< 1.5 × upper limit of normal (ULN) within 14 days prior to the first study treatment with the following exception:\r\n* Patients with known Gilbert's disease who have serum bilirubin level =< 3 × ULN may be enrolled.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? institutional upper limit of normal (IULN); patients with Gilbert’s syndrome may enroll if direct bilirubin ? 1.5 x IULNXx_NEWLINE_xXWithin 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 X institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN (upper limit of normal)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 2.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (except for patients with Gilberts' syndrome who must have normal direct bilirubin)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (upper limit of normal)Xx_NEWLINE_xXSerum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTo be performed within 14 days prior to day 1 of protocol therapy: total serum bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 3 X upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin up to 3.5 X ULN)Xx_NEWLINE_xXWithin 4 weeks of day 1: Total bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin >= 2 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); =< 3 x ULN for patients with known Gilbert disease.Xx_NEWLINE_xXWithin 3 days before the first dose of study drug: total bilirubin < upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin: =< 3 x upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s disease obtained =< 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin > 3 x institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.0 x ULN in patients with documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin below the upper limit of normal (ULN), excluding patients with Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin level ? 1.5 × the upper limit of normal (ULN) rangeXx_NEWLINE_xXTotal bilirubin =< 2 X upper limit laboratory normal (ULN); subjects with non-clinically significant elevations of bilirubin due to Gilbert’s disease are not required to meet these criteriaXx_NEWLINE_xXTotal bilirubin level =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert’s syndrome, who can have total bilirubin < 3 mg/DL)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x upper limit of normal within 14 days of treatment initiationXx_NEWLINE_xXTotal bilirubin ? 1.5 x institutional upper limit of normal (IULN) (unless due to diagnosis of Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) \r\n* For patients with Gilbert’s syndrome total bilirubin < 3.0 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x the institutional upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN), obtained within 7 days prior to first study treatmentXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXWithin 7-10 days of study drug administration: Total bilirubin < 3 X upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range.Xx_NEWLINE_xXBilirubin < 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin concentration of =< 1.5 x the upper limit of normal (ULN) rangeXx_NEWLINE_xXWithin 7 days prior to administration of study treatment: Total bilirubin =<1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert’s disease).Xx_NEWLINE_xXTotal serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome.Xx_NEWLINE_xXBilirubin =< 2.0 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 X upper limit of normal (ULN) for current age (? 3 X ULN if increase in bilirubin is attributable to Gilbert's Syndrome)Xx_NEWLINE_xXTotal bilirubin ? 1.5 X the upper normal limit of institution's normal rangeXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) unless elevation is thought to be due to Gilbert’s syndromeXx_NEWLINE_xXObtained with 21 days of registration: total bilirubin =< 3 x the upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin: =< 3 x upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 X institutional upper limit of normal OR direct bilirubin =< ULN for patients with total bilirubin > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin within normal institutional limits (patients with confirmed Gilbert’s syndrome with a total bilirubin =< 2.0 x upper limit of normal [ULN], may be included in this study)Xx_NEWLINE_xXTotal bilirubin < 1.5x upper limit of normal (ULN) unless increase is due to Gilbert’s disease or leukemic involvementXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (results within 7 days before study drug administration)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for age, andXx_NEWLINE_xXTotal bilirubin < 2.5 x upper limit of institutional normal reference range; patients with known Gilbert disease who have serum bilirubin =< 3 x upper limit of normal (ULN) may be enrolledXx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease or of non-hepatic origin who will be allowed to participate, provided bilirubin is =< 3 x institutional ULN.Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institution upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) with the following the exception that patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolledXx_NEWLINE_xXTotal bilirubin level ? 1.5 × the upper limit of normal (ULN) rangeXx_NEWLINE_xXNo more than 14 days prior to registration: Total bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal serum bilirubin within 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 1.5 x institutional upper limit of normal (ULN) or < 3 x ULN in patients with Gilbert's disease or liver involvementXx_NEWLINE_xXBilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXObtained within 14 days prior to the first study treatment (cycle 1, day 1): total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: 1) patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolledXx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXWithin 14 days of the first study treatment: Total bilirubin level =< 1.5 x the upper limit of normal (ULN) rangeXx_NEWLINE_xXWithin 14 days prior to registration: Bilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome.Xx_NEWLINE_xXTotal bilirubin (except for Gilbert’s syndrome) =< 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal within normalXx_NEWLINE_xXWithin 14 days prior to cycle 1 day 1 of treatment: Bilirubin =< 1.5 x upper limit of normal (ULN) (subjects with known Gilbert’s disease who have serum bilirubin =< 3.0 x ULN may be enrolled)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN) (after the HDT/ASCT)Xx_NEWLINE_xXTotal Bilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 2.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 3 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (with the exception of those with Gilbert syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXBilirubin >= 2 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin within 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< to 2.0 x normal.Xx_NEWLINE_xXTotal Bilirubin =< upper limit of normal [ULN]Xx_NEWLINE_xXWithin 4 weeks prior to the registration: bilirubin =< 1.5 X upper limit of normalXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXHepatic impairment, defined as total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible) orXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) OR direct bilirubin =< ULN with total bilirubin > 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (for patients with a diagnosis of Gilbert’s syndrome, direct bilirubin =< 1.5 x ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless Gilbert's disease in which case total bilirubin =< 3 x institutional ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institution’s upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal range (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation due to Gilbert’s syndrome obtained =< 7 days prior to registrationXx_NEWLINE_xXTotal bilirubin level =< 1.5 x the upper limit of normal (ULN) rangeXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless related to Gilbert’s or Meulengracht’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin ? 2.0 x institution’s upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN) (patients with diagnosed Gilbert’s syndrome will not be excluded if their direct bilirubin is within normal institutional limits)Xx_NEWLINE_xXTotal bilirubin level =< 1.5 x the upper limit of normal range (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normalXx_NEWLINE_xXSerum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN), measured within 28 days prior to administration of study treatmentXx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (ULN) for age and weightXx_NEWLINE_xXBilirubin > upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s disease obtained =< 14 days prior to registrationXx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin level =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert’s syndrome.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: \r\n* Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolledXx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional upper limit of normal ([ULN]; unless attributable to Gilbert’s disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 4.0 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN); if total bilirubin > 1.5 X ULN then direct bilirubin =< ULN (obtained =< 14 days prior to registration)Xx_NEWLINE_xXBilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin =< upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless due to Gilbert’s disease or disease-related hemolysis, then =< 3.0 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 ULN (upper limit of normal), unless due to Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin ?1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN) (obtained within 28 days prior to first study treatment)\r\n* Subjects with known Gilbert’s disease should have a serum bilirubin =< 3 x ULNXx_NEWLINE_xXTotal bilirubin must be less than or equal to (<=) 1.5 * the upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) (except in patients diagnosed with Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin with 1.5 x the upper limit of normal (ULN) institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligibleXx_NEWLINE_xXObtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin less than 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x upper limit of normal (ULN) within 14 days prior to the first study treatment (cycle 1, day 1) with the following exception:\r\n* Patients with known Gilbert disease who have serum bilirubin level ? 3 x ULN may be enrolledXx_NEWLINE_xXTotal bilirubin =< 2.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), obtained =< 14 days prior to registrationXx_NEWLINE_xXObtained =< 7 days prior to registration: Total bilirubin =< 1.5 x upper limit normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (ULN) (except in patients with Gilbert's syndrome; patients with Gilbert's syndrome may enroll if direct bilirubin is =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < institutional upper limit of normal (ULN), except for subjects with documented Gilbert’s syndrome, for which =< 3.0 x ULN or direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin less than or equal to 1.5 x upper limit of normal (ULN) (unless bilirubin rise is due to Gilbert’s syndrome or B-ALL or non-hepatic origin)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin < 2x institutional upper limit of normal (ULN) within 7 days prior to starting the study drug;Xx_NEWLINE_xXTotal bilirubin < 2 x upper limits of normal (ULN) except Gilbert syndrome where < 3 x ULN is allowedXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia in the absence of evidence of hemolysis or hepatic pathology) will be allowed to enroll after discussion with the principal investigator if total bilirubin is =< 3 x the upper limit of normal)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normalXx_NEWLINE_xXTransaminases < 5 x upper limit of normal (ULN) and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysisXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 2 x upper limit of normal (ULN) andXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal Bilirubin =< institutional upper level of normal (ULN) at cycle 1 day 1 of TPFXx_NEWLINE_xXTotal bilirubin > 1.5 x the upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin < 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (IULN)Xx_NEWLINE_xXSerum bilirubin > upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 × institutional upper limit of normal (except for patients with Gilbert disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome or liver metastasis who can have total bilirubin < 3.0 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 × ULN in the case of suspected/documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper normal limit if documented hepatic involvement with lymphoma, or =< 5 x upper normal limit if history of Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin within 2 x upper limit of normalXx_NEWLINE_xXBilirubin =< 2 x the upper limit of normal (except Gilbert’s syndrome)Xx_NEWLINE_xXObtained =< 14 days prior to randomization: Total bilirubin =< upper limit of normal (ULN)\r\n* NOTE: If total bilirubin is out of range then direct bilirubin must be =< ULNXx_NEWLINE_xXTotal bilirubin > 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) except for patients with known Gilbert syndromeXx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubinXx_NEWLINE_xXSerum total bilirubin: ? 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN), with the exception of patients with Gilbert syndrome who are required to have =< 3 X ULNXx_NEWLINE_xXTotal bilirubin < 3.0 x the upper limit of normal (ULN) for age (patients who have been diagnosed with Gilbert’s disease are allowed to exceed this limit)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN) (institutional upper limit of normal)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for the laboratoryXx_NEWLINE_xXTotal bilirubin; if cirrhosis present: part of Child Pugh requirement; if no cirrhosis: bilirubin should be =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with documented/suspected Gilbert's disease, bilirubin =< 3 x ULNXx_NEWLINE_xXTotal bilirubin < 2.0 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome), within 14 day prior to registrationXx_NEWLINE_xXBilirubin =< 3 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless due to Gilbert syndrome, in which case it should be =< 3.0 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 2.0 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for age, andXx_NEWLINE_xXPHASE I: Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s disease)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 2.0 X upper limit of normal (ULN)Xx_NEWLINE_xXConcentrations of total serum bilirubin within 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (< 3 x ULN if Gilbert’s disease)Xx_NEWLINE_xXSerum bilirubin < 1.5 x upper limit of normal valuesXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTransaminases =< 5 x upper limit of normal (ULN) and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysisXx_NEWLINE_xXTotal bilirubin < 1.25 x institutional upper limit of normalXx_NEWLINE_xXHepatic: total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin > upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > 1.5 x upper limit of normal (ULN) (unless evidence of Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin with normal institutional limits; NOTE: for this study, subjects with bilirubin levels > 1.5 upper limit of normal (ULN) are excluded from this enrollment in this studyXx_NEWLINE_xXBilirubin levels > 1.5 institutional upper limit of normal (IULN)Xx_NEWLINE_xXSerum bilirubin < 1.5 x institutional upper limit of normal (IULN) (except for patients with known Gilbert’s disease)Xx_NEWLINE_xXObtained =< 14 days prior to registration: Total bilirubin =< institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< to 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN), in case of Gilbert's syndrome, =< 2 x ULN within 30 days prior to C1D1Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x upper limit of normal (ULN) unless attributable to Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 3 x institutional upper limit of normal, unless there is a known history of Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ?1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome);Xx_NEWLINE_xXTotal bilirubin > 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin less than 1.5 X institutional upper limit of normal (IULN) except in patients with Gilbert’s syndrome who must have a total bilirubin less than 2.5 X IULNXx_NEWLINE_xXTotal bilirubin: =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x upper limit of normal (ULN), OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x international upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULNXx_NEWLINE_xXDONOR: Total bilirubin =< 2x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normalXx_NEWLINE_xXSerum bilirubin < 1.5 x upper limit of normal (ULN) except in patients with Gilbert’s syndrome as defined by > 80% unconjugated bilirubinXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for the laboratoryXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< international upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 X institutional upper limit of normalXx_NEWLINE_xXSerum bilirubin ? 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin within 1.5 x institutional level of normal or direct bilirubin =< upper limit of normal (ULN) for patient with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin > 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN) unless related to disease or patient known to have underlying Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 2.0 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolledXx_NEWLINE_xXSerum total bilirubin =< 2.0 x upper limit normal (ULN) or =< 3.0 x ULN if deemed to be elevated due to leukemiaXx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN) (except for known Gilbert’s syndrome/familial non-hemolytic jaundice)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN); for subjects with Gilbert’s disease =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN) (unless related to lymphoma or Gilbert’s disease) OR =< 5 x ULN for subjects with documented or suspected Gilbert’s disease, or related to involvement of the liver by the lymphoma, obtained =< 7 days prior to registrationXx_NEWLINE_xXTotal bilirubin < 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXDirect bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXARM B COHORT 2: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment)Xx_NEWLINE_xXTotal bilirubin < 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXAdequate liver function: Alanine transaminase (ALT) < 2 x ULN and bilirubin < 1.5 x Upper Limit of Normal (ULN), (or if bilirubin is between 1.5 - 2 x ULN, they must have a normal conjugated bilirubin).Xx_NEWLINE_xXTotal bilirubin < 1 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 2.5 x upper limit of normal (ULN); direct bilirubin < 2 x ULN for Gilbert's syndrome;Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, total bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubinXx_NEWLINE_xXTotal bilirubin >= 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.5 × institutional upper limit of normalXx_NEWLINE_xXSerum bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN) unless considered due to Gilbert’s syndromeXx_NEWLINE_xXBilirubin =<1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0Xx_NEWLINE_xXTREATMENT: Bilirubin < 3 × upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin (Tbili) < 1.6 x upper limit of normal (ULN)\r\n* Except subjects with known Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin < 3 the upper limit of normal (ULN), except patients who are assigned to receive docetaxel must have liver function tests (serum transaminases, bilirubin) that are within 1.5 x the ULNXx_NEWLINE_xXMust be met within 28 days of C1D1: Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless evidence of Gilbert’s syndrome, in which case, direct bilirubin must be =< 1.0 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin level =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 2.0 x the upper limit of normal and direct bilirubin within normal limitsXx_NEWLINE_xXTotal bilirubin =<1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome total bilirubin >2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin must be less than or equal to (<=) 1.5* the upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 3 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin: =< 3 x upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dlXx_NEWLINE_xXTotal bilirubin < 2 x upper limits of normal (ULN) except Gilbert’ syndrome where < 3 x ULN is allowedXx_NEWLINE_xXTREATMENT: Patients with bilirubin ? 2 x upper limit of normalXx_NEWLINE_xXSerum bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome (< 5 if liver involvement with primary tumor)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), obtained within 30 days of study registrationXx_NEWLINE_xXSerum total bilirubin within normal range (or =< 1.5 x upper limit of normal [ULN] if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome), obtained =< 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin within normal range; for patients with liver metastases, serum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin must be less than or equal to 1.5 x upper limit of normal (ULN), andXx_NEWLINE_xXPatients must have bilirubin < 1.5 x normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), =< 1.8 x ULN with liver metastasesXx_NEWLINE_xXResearch participant serum total bilirubin does not exceed 2 x normal limitXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal obtained no more than 28 days prior to the start of neoadjuvant endocrine therapyXx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin < 2.0 x ULN (upper limit of normal)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin < or = to 1.5 X the upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin within (or under) normal limits (OR total bilirubin =< 3.0 x institutional upper limit of normal [IULN] with direct bilirubin within normal range in patients with well documented Gilbert syndrome)Xx_NEWLINE_xXTotal bilirubin >= 2 x the upper limit of normalXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's syndrome)Xx_NEWLINE_xXSerum bilirubin of =< 1.5 × upper limit of normalXx_NEWLINE_xXSerum bilirubin within normal range (or =< 1.5 x upper limit normal [ULN] if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)Xx_NEWLINE_xXSerum direct bilirubin =< 2.0 x ULN (upper limit of normal)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal rangeXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) OR 3 x ULN for Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin > 1.5 x upper limit of normal (ULN) unless related to Gilbert's syndrome or hemolysisXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN (upper limit of normal)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 × ULN)Xx_NEWLINE_xXTotal bilirubin =< upper normal limit (obtained =< 7 days prior to registration)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (except for patients with documented Gilbert’s disease)Xx_NEWLINE_xXSerum bilirubin < 2x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXWithin 14 days prior to registration: Serum total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) obtained within 2 weeks prior to registrationXx_NEWLINE_xXRANDOMIZED PHASE II (ARMS K AND L): Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which Bilirubin =< 3 x upper limit of normal [ULN] is permitted); obtained within 2 weeks prior to registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0Xx_NEWLINE_xXBilirubin =< 1.5 x the upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN); andXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) ANDXx_NEWLINE_xXSerum total bilirubin =< 2.0 x ULN (upper limit of normal)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXWithin 14 days of enrollment: Total bilirubin level > 1.5 x upper limit or normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) (Gilbert's allowed 3 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 mg/dl or =< 2.5 x upper limit of normal (ULN) for age (unless Gilbert's syndrome)Xx_NEWLINE_xXBilirubin =< 3 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit laboratory normal (ULN); subjects with non-clinically significant elevations of bilirubin due to Gilbert’s disease are not required to meet these criteriaXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULNXx_NEWLINE_xXTotal bilirubin less than 2 x upper limit of normalXx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 2 x upper limit of normalXx_NEWLINE_xXBilirubin less than or equal to 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin (total) < 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN), within 14 days prior to study entryXx_NEWLINE_xXBilirubin =< 3 x upper limit of normalXx_NEWLINE_xXTotal (T.) bilirubin =< 3 X upper limit of normal (ULN)Xx_NEWLINE_xXHepatic (bilirubin < 2 x upper limit of normal [ULN]) orXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless considered due to Gilbert’s syndrome or hemolysis)Xx_NEWLINE_xXBilirubin =< 1.5 x normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin:\r\n* If no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN)\r\n* If known liver metastases, then: total bilirubin < 2.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x local institutional upper limit of normal (ULN)\r\n* If elevated total bilirubin is due Gilbert’s disease or disease-related hemolysis then total bilirubin =< 3.0 x local institutional ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if documented hepatic involvement with lymphoma, or =< 5 x ULN if history of Gilbert's syndrome, without use of growth factor support for 1 weekXx_NEWLINE_xXTotal bilirubin =< 1.5 × the upper limit of the normal range (ULN) obtained =< 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin of =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXPatient must have adequate hepatic function as defined by total bilirubin < 2.5 x IULN (institutional upper limit of normal)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normalXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin must be < 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 3 x upper limit of normalXx_NEWLINE_xXSerum bilirubin =< 2 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x normalXx_NEWLINE_xXBilirubin < 5 x upper limit of normalXx_NEWLINE_xXBilirubin < 5 x normalXx_NEWLINE_xXBilirubin < 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin greater the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ?1.5 x the upper limit of the normal range (ULN) (except for Gilbert syndrome: direct bilirubin ?2 x ULN).Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN) (if > 2 x ULN direct bilirubin is required and should be =< 1.5 x ULN), obtained =< 14 days prior to registrationXx_NEWLINE_xXObtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXHepatic-bilirubin > 2 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< upper limit of normal (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL)Xx_NEWLINE_xXDirect bilirubin ? 2x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin must be less than or equal to 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation greater than 1.5 x Upper limit of normal (ULN) to 3 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; andXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN); NOTE: concomitant elevations in bilirubin above 1.0 x ULN is not permittedXx_NEWLINE_xXBilirubin =< to 2.0 x normalXx_NEWLINE_xXTotal Bilirubin =< institutional upper level of normal (ULN)Xx_NEWLINE_xXTotal bilirubin: < 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin ? 2.0 x the upper limit normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin ?1.5x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 × institutional upper limit of normal (ULN) (however, patients with known Gilbert’s disease who have serum bilirubin level ? 3 × ULN may be enrolled)Xx_NEWLINE_xXSerum total bilirubin > 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 28 days prior to administration of study treatment.Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTo be performed within 14 days prior to day 1 of protocol therapy: total bilirubin =< 1.5 x upper limit of normal (ULN) (=< for Gilbert's syndrome or documented hepatic involvement by lymphoma)Xx_NEWLINE_xXWithin 28 days prior to administration of study treatment: Total bilirubin ? 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin ?1.5 × upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =<1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x normal for ageXx_NEWLINE_xXWithin 14 days prior to the first study treatment (cycle 1, day 1): Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled.Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXObtained ? 14 days prior to registration: total bilirubin ? 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome, in which case the direct bilirubin must be ? 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome).Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except participants with Gilbert’s Syndrome who must have normal direct bilirubin)Xx_NEWLINE_xXWithin 14 days prior to first dose of study drug treatment: Serum bilirubin =< 1.5 x the upper limit of normal (ULN); patients with known Gilbert’s disease may have a bilirubin =< 3.0 x ULNXx_NEWLINE_xXBilirubin ? 1.0 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin (TBL) =< 1.5 x upper limit of normal (ULN) except patients with documented Gilbert's syndrome (> 3 x ULN), within 28 days of day 0.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXBilirubin < 2 x the upper limit of normal (except patients with Gilbert Syndrome in whom bilirubin level of > 2 x upper normal limit will be allowed)Xx_NEWLINE_xXWithin 14 days of study registration: Total bilirubin =< 3 x upper limit of institutional normal (ULN)Xx_NEWLINE_xXWithin 14 days prior to day 1 of protocol therapy unless otherwise stated: Total bilirubin =< 1.5 X upper limit of normal (ULN) OR if Gilbert’s syndrome =< 3.0 X ULNXx_NEWLINE_xXTotal bilirubin < institutional upper limit of normal (ULN), except for subjects with documented Gilbert’s syndrome, for which =< 3.0 x ULN or direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXObtained =< 21 days prior to registration: Total bilirubin =< institutional upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert’s syndrome.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXSerum bilirubin =< 2.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.5 X institutional upper limit of normal or =< 3 in subjects with Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXLiver function tests performed within 3 weeks prior to starting study therapy must have total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN) or if total bilirubin is > 1.5 X ULN, the direct bilirubin =< ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 × institutional upper limit of normal (ULN), unless known Gilbert’s syndrome has been diagnosedXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN; unless attributable to Gilbert’s disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 2.5 x ULN)Xx_NEWLINE_xXTotal bilirubin <=<1.5 x the upper limit of normal unless considered due to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin within institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (institutional upper limit of normal) (patients with Gilbert’s syndrome may have direct bilirubin > 2.5 x ULN)Xx_NEWLINE_xXTotal bilirubin within normal ranges unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), obtained within 14 days prior to the first study treatment (cycle 1, day 1) with the following exception:\r\n* Patients with known Gilbert disease who have total bilirubin level =< 3 x ULN may be enrolledXx_NEWLINE_xXTo be performed within 28 days prior to day 1 of protocol therapy: Total serum bilirubin < upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 4 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), obtained =< 7 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (ULN) (< 2.0 x ULN for subjects with documented Gilbert’s syndrome or < 3.0 x ULN for subjects for whom the indirect bilirubin level suggests an extrahepatic source of elevation)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN), (except for patients with known Gilbert’s syndrome who must have normal direct bilirubin)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)Xx_NEWLINE_xXTotal bilirubin =< 2.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXDirect bilirubin =< 1.5 x upper limit of normal (ULN) for age, andXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 2 x upper limit of normal (ULN), obtained within 14 days prior to registration for protocol therapyXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 2.5 upper limit of normal (ULN)Xx_NEWLINE_xXTUMOR BIOPSY SEQUENCING: Total bilirubin < 1.5 x institutional upper limit of normalXx_NEWLINE_xXTREATMENT: Total bilirubin < 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of institutional normalXx_NEWLINE_xXBilirubin < 3 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXMeasured within 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), obtained =< 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin within normal institutional limits; EXCEPTION: subjects with known Gilbert's disease: total bilirubin =< 3 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXWithin 28 days prior to administration of therapy: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin (total) < 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< the institutional upper limit of normalXx_NEWLINE_xXDirect bilirubin < 1.5 x upper limit of normal (ULN) for age and institutionXx_NEWLINE_xXTotal bilirubin below normal institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL x the institutional upper limit of normalXx_NEWLINE_xXSerum direct bilirubin < 2 x institutional upper limit of normalXx_NEWLINE_xXSecondary Registration: total serum bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin < 2 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin greater than 1.5 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 1.0 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, =< 3 mg/dlXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper normal limit (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (bilirubin < 3 x institutional upper limit of normal for Gilbert’s syndrome)Xx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for age, andXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normalXx_NEWLINE_xXBilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with well-documented Gilbert’s syndrome) (obtained =< 14 days prior to registration)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin: =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception:\r\n* Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolledXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 institutional upper limit of normal (ULN)Xx_NEWLINE_xXPHASE II: Total bilirubin =< 1.5 institutional upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin < 1.5 x upper limit or normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for the institutionXx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN) within 14 days of enrollmentXx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (bilirubin < 3 × institutional upper limit of normal for Gilbert’s syndrome)Xx_NEWLINE_xXBilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome, within 2 weeks of the first dose of study treatmentXx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndromeXx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 × upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN) (=< 3.0 if Gilbert’s syndrome)Xx_NEWLINE_xXBilirubin (total) less than or equal to the upper limit of normal; an exception to this may be allowed for participants with Gilbert’s syndrome with prior approval by the protocol chairXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal, measured within 28 days prior to administration of study treatmentXx_NEWLINE_xXBilirubin less than 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 2 x upper limit of normal valueXx_NEWLINE_xXTotal bilirubin =< 1.5 institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 2.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > 2 x upper limit of normal (ULN) (except in the case of subjects with documented Gilbert’s disease > 3 x ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXDirect bilirubin =< 1.5 X upper limit of normal (ULN) (subjects with Gilbert’s syndrome and elevations of indirect bilirubin only are eligible)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin >= 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (ULN) (except for patients with Gilbert's syndrome and elevations of indirect bilirubin)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal assessed within seven (7) days prior to the start of therapyXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin (TB) =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 3 x upper limit of normalXx_NEWLINE_xXTotal bilirubin below the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible), within 21 days of initiation of protocol therapyXx_NEWLINE_xXObtained within 28 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXBilirubin =< 1.5 X laboratory normalXx_NEWLINE_xXBilirubin =< 2 x institutional upper limit of normal (ULN); these results must be obtained within 28 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN with Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin ? 1.5 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (IULN) (unless due to Gilbert syndrome) within 42 days prior to registrationXx_NEWLINE_xXBilirubin > 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert's syndrome] are eligible) orXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (or =< 3.0 mg/dL if known Gilbert’s syndrome)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN) unless attributable to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXCLINICAL/LABORATORY CRITERIA: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); these results must be obtained within 28 days prior to registrationXx_NEWLINE_xXIf no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN); if known liver metastases, then: total bilirubin < 2.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) except in the case of patients with Gilbert’s diseaseXx_NEWLINE_xXSerum bilirubin up to 1.2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.0 x ULN in patients with documented Gilbert's syndrome)Xx_NEWLINE_xXBilirubin less than or equal to 1.5 x institutional/laboratory upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin within institutional upper limit of normal (IULN)Xx_NEWLINE_xXBilirubin ? 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome;Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal; unless due to Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin < 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXWithin 14 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXAMKL PATIENTS: Total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normalXx_NEWLINE_xXTotal bilirubin < 1.5 x of institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal in the absence of Gilbert’s disease; for patients with Gilbert’s syndrome: direct bilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXtotal bilirubin must be less than or equal to 1.5 x upper limit of normal (ULN); andXx_NEWLINE_xXSUB-PROTOCOL AIM A: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin < 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin within upper limit of normal (ULN),Xx_NEWLINE_xXSerum bilirubin at least 1.5 × upper limit of normal (ULN) or at least 3 × ULN if Gilbert's disease is documentedXx_NEWLINE_xXTotal bilirubin <1.5 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) or normal direct bilirubin if the patient has GilbertsXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal Bilirubin ? 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 2 x the institutional upper limit of normalXx_NEWLINE_xXWithin 14 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXPatient has > 1.5 x upper limit of normal (ULN) total bilirubin unless history of Gilbert's syndromeXx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin superior to 2 x ULN (Upper Limit of Normal).Xx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 X the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndromeXx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5X upper limit of normal (ULN) unless secondary to Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin < 3 X upper limited of normal (ULN) for ageXx_NEWLINE_xXDirect bilirubin equal to or less than 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (Participants with serum bilirubin abnormalities greater than this specified limit are eligible only if they have known Gilberts disease.)Xx_NEWLINE_xXTotal bilirubin >1.5 x upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin less than 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > institutional upper limit of normal orXx_NEWLINE_xXBilirubin < or equal to 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin: =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin < upper limit of normal (ULN) (except for Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease who will be allowed to participateXx_NEWLINE_xXTotal bilirubin =< 2 x UIHC upper limit of normalXx_NEWLINE_xXTotal bilirubin less than 2-fold upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal; =< 3.0 upper limit of normal (ULN) accepted in subjects with Gilbert’s syndromeXx_NEWLINE_xXBilirubin < 3 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin =< 2 x upper limit of normal (ULN) obtained within 4 weeks prior to registrationXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 2 x the upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXBilirubin < 1.5 X ULN (the upper limit of normal) (subjects with confirmed Gilbert disease as the cause of their elevated bilirubin are to be permitted)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x upper limit of normal (ULN) with the following exception:Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); patients with known history of Gilbert syndrome and total bilirubin < 2 x ULN and normal aspartate aminotransferase (AST)/alanine aminotransferase (ALT) are eligible, obtained =< 7 days prior to registrationXx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal (ULN) (< 2.0 x ULN for subjects with documented Gilbert’s syndrome or < 3.0 x ULN for subjects for whom the indirect bilirubin level suggests an extrahepatic source of elevation)Xx_NEWLINE_xXWithin 14 days of enrollment: Bilirubin =< 1.5 the upper limit of normal (ULN) for the institution\r\n* For patients with known Gilbert's disease: bilirubin =< 3 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if documented hepatic involvement with lymphoma, or =< 5 x ULN if history of Gilbert's syndromeXx_NEWLINE_xXDirect bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN), or direct bilirubin =< ULN in patients with Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal, or, for patients who have undergone biliary stenting, total bilirubin of =< 2 or two down trending valuesXx_NEWLINE_xXTotal bilirubin =< 1.5 X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert’s, for whom the maximum will be 2.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), except in cases of Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)Xx_NEWLINE_xXTotal bilirubin =< 3 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN) obtained =< 7 days prior to randomization; patients with known Gilbert’s syndrome who have serum bilirubin =< 3 X ULN may enrollXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (ULN) (or =< 3 X ULN if Gilbert’s syndrome present or if bilirubin increase related to MF)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal, within 14 days of study registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN, unless due to Gilbert syndrome, in which case it should be =< 3.0 x ULN)Xx_NEWLINE_xXTotal bilirubin < 2 X institutional upper limit of normal (ULN) unless predominantly indirect and therefore likely due to hemolysis or Gilbert’s syndromeXx_NEWLINE_xXWithin 72 h of initiating study treatment: Bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN for subject with total bilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN) unless history of Gilbert’s syndrome documented prior to first-line treatment of cancer and other liver function tests are within normal limitsXx_NEWLINE_xXTotal bilirubin =< 1.25 x upper limit normal (ULN)Xx_NEWLINE_xXBilirubin < 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin less than 3 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN) (unless bilirubin rise due to Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper normal limit, or =< 3 x upper normal limit if documented hepatic involvement with lymphoma, or =< 5 x upper normal limit if history of Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients diagnosed with Gilbert’s disease) (within 7 days prior to registration)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN) or if total bilirubin is > 2 x ULN, the direct bilirubin must be normalXx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (unless Gilbert's syndrome)Xx_NEWLINE_xXWithin 14 days prior to the first study treatment (cycle 1, day 1): Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolledXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXObtained within 14 weeks prior to registration on study: bilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubinXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXSerum total bilirubin: =< 1.5 x upper limit of normal (ULN) obtained within 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 3 x upper limit of normal [ULN])Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.5 x the upper limit of normalXx_NEWLINE_xXSerum total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); if patient has known Gilbert’s syndrome, direct bilirubin =< 2.0 x ULN obtained =< 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin > 1.5 x institutional upper limit of normal (ULN), within 21 days of initiation of protocol therapyXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to randomization)Xx_NEWLINE_xXTotal bilirubin level =< 2.0 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 2.0 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin below institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal for ageXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN), except for patients with documented history of Gilbert’s disease who may have direct bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin within ULN (upper limit of normal)Xx_NEWLINE_xXSerum bilirubin =< upper limit of normal; or total bilirubin =< 2.0 x the ULN with direct bilirubin within the normal range in patients with well documented Gilbert syndromeXx_NEWLINE_xXTotal serum bilirubin =< institutional upper limit of normal (ULN) obtained =<14 days prior to randomizationXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal\r\n* Note: patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigatorXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin < 3 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 * the upper limit of the normal range (ULN).Xx_NEWLINE_xXDirect bilirubin ? 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 upper limit of normal within 30 days prior to registrationXx_NEWLINE_xXTotal bilirubin level <= 1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's diseaseXx_NEWLINE_xXTotal serum bilirubin =< institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXWithin 14 days of registration: Total bilirubin < institutional upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 × the institutional upper limit of the normal range (IULN)Xx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin less than or equal to the upper limit of normalXx_NEWLINE_xXSerum total bilirubin ?1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease or disease involvement following approval by the Medical Monitor;Xx_NEWLINE_xXAT THE TIME OF INFUSION: Bilirubin ? 3 x upper limit of normalXx_NEWLINE_xXTotal bilirubin normal;Xx_NEWLINE_xXTotal bilirubin =< upper limit of normalXx_NEWLINE_xXPatient has total bilirubin > 2 x ULN (upper limit of normal)Xx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin must be within the limit of normalXx_NEWLINE_xXTotal bilirubin < institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 1.5 x upper limit of normal [ULN])Xx_NEWLINE_xXTotal bilirubin =< 4 X institutional upper limit of normal unless 2nd to Gilbert’s diseaseXx_NEWLINE_xXAt least 4 weeks (28 days) prior to registration: Serum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 2 x institutional upper limitXx_NEWLINE_xXBilirubin ? 1.5 x upper limit of normal (ULN); does not apply to patients with Gilbert's syndromeXx_NEWLINE_xXSerum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with a confirmed diagnosis of Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5x the upper limit of normalXx_NEWLINE_xXTotal bilirubin ? 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.8 X upper limit of normalXx_NEWLINE_xXBilirubin > 1.5 x institutional upper limit of normal (ULN); patients with benign hyperbilirubinemia (e.g., Gilbert’s syndrome) are eligibleXx_NEWLINE_xXTotal bilirubin =< 1.5 × institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< x 1.5 upper limit of institutional normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper normal limit (UNL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (patients with diagnosed Gilbert’s syndrome will not be excluded if their direct bilirubin is within normal institutional limits)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN).Xx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin within 2 x upper limit of normalXx_NEWLINE_xXAdequate hepatic function, with bilirubin < 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXObtained within 14 days prior to the first study treatment (cycle 1, day 1); total bilirubin ? 1.5 x upper limit of normal (ULN) with the following exception: \r\n* Patients with known Gilbert disease who have serum bilirubin level ? 3 x ULN may be enrolledXx_NEWLINE_xXTotal bilirubin level =< 1.5 x the upper limit of normal (ULN) rangeXx_NEWLINE_xXBilirubin < 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (ULN); in case of known Gilbert’s syndrome, < 2 x ULN is allowedXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilberts diseaseXx_NEWLINE_xXPART B: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), unless due to Gilbert’s syndromeXx_NEWLINE_xXDirect bilirubin within upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin < 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's disease)Xx_NEWLINE_xXTotal bilirubin < 2 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x ULN for patients with Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< the upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) unless Gilbert’s syndrome or disease infiltration of the liver is presentXx_NEWLINE_xXTotal bilirubin =< 1.5 × upper limit of normal (ULN) (or =< 2.5 x ULN for subjects with asymptomatic Gilbert’s syndrome)Xx_NEWLINE_xXNormal serum bilirubinXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN) unless attributable to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin\r\n* If cirrhosis present: part of Child Pugh requirement\r\n* If no cirrhosis: bilirubin (bili) should be =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum total and direct bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > 5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 X institutional ULN (if the patient has liver metastases)Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin > 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); 3 x ULN if due to hepatic involvementXx_NEWLINE_xXTotal bilirubin ? 1.5 × upper limit of normal (ULN) (? 2 x ULN for subjects with cholangiocarcinoma)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN) (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)Xx_NEWLINE_xXObtained =< 7 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (unless elevated from documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (unless due to Gilbert's disease)Xx_NEWLINE_xXTotal bilirubin > 3 x upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< institutional upper level of normal (ULN)Xx_NEWLINE_xXSerum bilirubin >= 1.5 x upper limit of normal (ULN) or for patients with Gilbert's disease, >= 3 mg/dL at the screening visitXx_NEWLINE_xXTotal bilirubin < 1.5 x upper normal institutional limitXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin =< the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) or =< 3.0 x institutional ULN if the patient has Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin > 1.5 upper limit of normal (ULN) when it is clearly not related to GVHDXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); if patient has Gilbert’s disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin =< 2 X institutional ULNXx_NEWLINE_xXTotal serum bilirubin < institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin less than or equal to 2 x upper limit of normal (ULN) (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXWithin one week of study entry: Total bilirubin =< 1.5 x upper limit of normal, OR, for patients who have undergone biliary stenting, total bilirubin =< 2.0 OR two downtrending valuesXx_NEWLINE_xXBilirubin =< 1.5 the upper limit of normal (ULN) for the institutionXx_NEWLINE_xXBilirubin =< 1.5 X the upper limit of normal (ULN); for participants with known Gilbert’s disease, bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN); =< 3 x institutional ULN if the patient has Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin less than 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 3.0 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 2 x the upper limit of normal (except Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x the upper limit of the normal range (ULN).Xx_NEWLINE_xXTotal bilirubin < 1.5 X institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 3 X upper limit of normal [ULN])Xx_NEWLINE_xXTotal bilirubin =< 2 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x ULN (upper limit of normal)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) obtained =< 14 days prior to randomizationXx_NEWLINE_xXBilirubin < 2 X upper limit of normal (ULN)Xx_NEWLINE_xXDirect bilirubin =< 1.5 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x institutional upper limit normalXx_NEWLINE_xXWithin 14 days after subjects signed the treatment consent: Total bilirubin < upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal if no biliary stenting was doneXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) (except for Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN) (obtained =< 14 days prior to registration)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXBilirubin =< 1.5 X upper limit of normal (ULN) or =< 3 X ULN for patients with Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 2.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin less than institutional upper limit of normal; NOTE: patients with a diagnosis or history of Gilberts will be eligibleXx_NEWLINE_xXBilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXARMs A, C, D: Total bilirubin within normal range (or =< 1.5 X upper limit of normal [ULN] if liver metastases are present); or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with Gilbert syndromeXx_NEWLINE_xXTotal bilirubin within =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be normalXx_NEWLINE_xXBilirubin within the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXBilirubin* =< 2 x upper limit of normal\r\n* In the absence of Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (=< 3 x institutional ULN in patients with Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin ? 2 × upper limit of normal (ULN) or < 3 x ULN for patients with Gilbert-Meulengracht SyndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > 1.5 × upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (obtained within 14 days prior to the first study treatment [course 1, day 1]) with the following exception:\r\n* Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolledXx_NEWLINE_xXTotal serum bilirubin =< 1.5 X upper limit of normal (ULN) except for subjects with known Gilbert’s disease, who may enroll if the conjugated bilirubin is =< 1.5 ULNXx_NEWLINE_xXTotal bilirubin < the upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN); (unless Gilbert's syndrome, for which bilirubin =< 3 x institutional upper limit of normal [ULN], without concurrent clinically significant liver disease), obtained within 14 days prior to first treatmentXx_NEWLINE_xXBilirubin < 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin < 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) (excluding Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x laboratory upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 X institutional upper limit of normalXx_NEWLINE_xXSerum bilirubin < 1.5 x normalXx_NEWLINE_xXDONOR: Bilirubin =< 2.5 x upper limit of normal (ULN)Xx_NEWLINE_xXPatients with bilirubin =< 2 x upper limit of normalXx_NEWLINE_xXSerum Bilirubin must be ? 3 x Upper Limit of Normal (ULN) if this elevation is solely due to ASM/MCL, otherwise serum bilirubin must beXx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x normalXx_NEWLINE_xXSerum bilirubin =< 2 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXBilirubin =< upper limit of normal (ULN); for patients with Gilbert’s disease, =< 2.5 x ULN is allowedXx_NEWLINE_xXTotal bilirubin =< 1.5 institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ?2 × upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal, unless known Gilbert's syndromeXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) (unless known Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) except in patients with Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal (ULN) rangeXx_NEWLINE_xXTotal bilirubin > upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 × upper limit of normal (ULN) for the laboratory unless resulting from hemolysisXx_NEWLINE_xXTotal bilirubin =< within upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limits of normal (ULN) except Gilbert’s syndrome where < 3 x ULN is allowedXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXDirect bilirubin =< 2.0 x upper limit of normal (ULN) (unless considered due to leukemia involvement)Xx_NEWLINE_xXTotal serum bilirubin < 2 x upper limit of normal (unless due to hemolysis or Gilbert’s syndrome, then no upper limit)Xx_NEWLINE_xXTotal bilirubin > 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x laboratory upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin: within normal institutional limits; if, however, the participant has Gilbert’s disease or unconjugated hyperbilirubinemia which is felt to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x upper limit of normal [ULN])Xx_NEWLINE_xXTotal bilirubin =< 1.5 × upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin: < 1.5 x upper limit of institutional normal for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXBilirubin >= 3 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 3 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 2.0 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper normal limit, or =< 5 x upper normal limit if documented hepatic involvement with lymphoma or history of Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the institutional upper-normal limit (IUNL)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< upper limit of normalXx_NEWLINE_xXMESOTHELIOMA COHORTS (COHORTS 1 AND 2 ONLY): Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXLUNG ADENOCARCINOMA COHORT (COHORT 3 ONLY): Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXPANCREATIC CANCER COHORT (COHORT 4 ONLY): Total bilirubin =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normal; for patients with Gilbert’s syndrome or levels of indirect bilirubin above the upper limit of normal, direct bilirubin will be used for eligibility and should be < 1.5 x institutional upper limit of normalXx_NEWLINE_xXSELUMETINIB ARM: Serum bilirubin > 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)\r\n* Patients with Gilbert’s disease: =< 3 x ULNXx_NEWLINE_xXTotal bilirubin within 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) except for patients with known Gilbert syndromeXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normalXx_NEWLINE_xXWithin 14 days prior to first study treatment: Total bilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin <=1.5*upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 3 x the upper limit of normal (ULN), +/- 7 days from date of ICF signingXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x laboratory upper limit of normalXx_NEWLINE_xXBilirubin =< institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal Bilirubin < 2 X upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin: within normal institutional limitXx_NEWLINE_xXBilirubin =< 2 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 2.0 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin > upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal if no biliary stenting was doneXx_NEWLINE_xXTotal bilirubin =< 1.5 institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< to 2.0 x normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXSerum bilirubin less than 3 X upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal, andXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin of =< 2 upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< upper limit of normal (ULN) (except for subjects with Gilbert’s disease who are eligible despite elevated serum bilirubin level)Xx_NEWLINE_xXTotal bilirubin ? upper limit of normal (ULN);Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > 1.5×ULN (upper limit of normal).Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0Xx_NEWLINE_xXSerum bilirubin =< 2 X institutional upper limit of normal (IULN)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin <=upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN (upper limit of normal)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin no more than 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 3 x institutional upper limit of normalXx_NEWLINE_xXSerum bilirubin =< 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal; Note: patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigatorXx_NEWLINE_xXSerum bilirubin <=1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN), unless presence of Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 2 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 7 days prior to registrationXx_NEWLINE_xXTotal bilirubin > institutional upper limit of normal (ULN), unless due to hemolysis or Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin < 1.5 x institutional upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 × upper limit of normal (ULN), except in patients with previously documented Gilbert’s syndrome, in which case the direct bilirubin should be less than or equal to the ULNXx_NEWLINE_xXTotal bilirubin =< institution upper limit of normalXx_NEWLINE_xXserum bilirubin ?1.5 X ULN (Upper Limit of Normal)Xx_NEWLINE_xXTotal bilirubin ? 2 x Upper Limit of Normal (ULN)Xx_NEWLINE_xXSerum total bilirubin ? 1.5 x upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin > 2 x institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional upper limit of normalXx_NEWLINE_xX> 1.5 x upper limit of normal (ULN) total bilirubinXx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXSerum bilirubin within normal range (or total bilirubin =< 3.0 x upper limit of normal [ULN] with direct bilirubin within normal range in patients with well documented Gilbert syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (unless associated with Gilbert’s syndrome)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x normalXx_NEWLINE_xXBilirubin ? 1.5 X upper limit of normalXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.5 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal; note: patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigatorXx_NEWLINE_xXTotal bilirubin 1.5 x normal for age, ANDXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXCohort A: Total bilirubin less than 1.5 x upper limit of normal (ULN) (unless known Gilbert's disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert's disease, bilirubin =< 3.0 mg/dLXx_NEWLINE_xXBilirubin within 1.5 x the upper limit of normal for age, with the exception of those with Gilbert syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXBilirubin =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal/direct bilirubin < 1.5 X institutional upper limit of normal; patients with elevation of indirect (unconjugated) bilirubin alone, as in Gilbert’s syndrome, are eligibleXx_NEWLINE_xXBilirubin =< 3.0 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin ?1.5 × upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin <1.5 x upper limit of normal (ULN), unless considered due to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin within 1.5 x of the upper limit of normal (ULN) institutional limits, patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligibleXx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), or if total bilirubin is > 1.5 ULN, the direct bilirubin must be normalXx_NEWLINE_xXSerum bilirubin must be within the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > 1.5 x upper limit of normal.Xx_NEWLINE_xXTotal bilirubin less than 2.5 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin within 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin < 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXBilirubin =< the institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)\r\n* Except in case of Gilbert diseaseXx_NEWLINE_xXTotal bilirubin less than upper limit of normal (ULN) (within four weeks prior to the study)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome or of non-hepatic originXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN), If patient has known Gilbert’s syndrome, direct bilirubin < 2.0 x ULNXx_NEWLINE_xXSerum total bilirubin < 2.0 x upper limit normal (ULN) (or < 3.0 x ULN if deemed to be elevated due to leukemia or Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.5 x upper limit of normal (ULN) except if the elevation is due to Gilbert’s syndrome (allowable at =< 5 x ULN) or myelofibrosis (per principle investigator [PI] discretion)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin (TBL) < 1.5 × upper limit of normal (ULN; except for subjects with documented Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubinXx_NEWLINE_xXSerum bilirubin < 2 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin =< ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 X institutional upper limit of normal (unless associated with Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.2 x upper limit of normal (ULN) unless due to Gilbert’s diseaseXx_NEWLINE_xXSerum bilirubin < 3.0 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXBilirubin =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.2 institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin >= 1.5 x upper limit of normal (ULN) (unless documented Gilbert’s)Xx_NEWLINE_xXTotal bilirubin < 2.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXUnless felt due to underlying disease and approved by the overall PI: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); patients with Gilbert’s disease may have total bilirubin up to =< 3 x institutional ULNXx_NEWLINE_xXDirect bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (=< 1.5 x institutional upper limit of normal [ULN] in patients with well documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) except patients with documented Gilbert’s syndrome within 28 days prior to registrationXx_NEWLINE_xXBilirubin ?1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome;Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal for ageXx_NEWLINE_xXSerum total bilirubin ? 1.5 x upper limit of normal (ULN) within 14 days prior to registrationXx_NEWLINE_xXSerum bilirubin count < 1.5 x normalXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal, unless there is a known history of Gilbert’s diseaseXx_NEWLINE_xXSerum bilirubin count < 1.5 x upper limit normal (ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin less than or equal to 1.5 x upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x upper-normal limit (ULN)Xx_NEWLINE_xXTotal bilirubin within the upper limit of normal based on institutional valuesXx_NEWLINE_xXBilirubin less than 1.5 x normal limit (NL)Xx_NEWLINE_xXTotal bilirubin ? 1.5xULN (upper limit of normal)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal for age, andXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal serum bilirubin (TBL) ?1.5 × upper limit of normal (ULN);Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN) (unless known Gilbert syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.0 upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN); an exception to this may be allowed for participants with Gilbert’s syndrome with documented approval by the protocol chairXx_NEWLINE_xXTotal bilirubin < 2 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXPatient has > 1.5 x upper limit of normal (ULN) total bilirubinXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (except for Gilbert's syndrome)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin\t< 1.5 x normalXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 2 x upper limit normalXx_NEWLINE_xXTotal bilirubin > upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin < 5 x upper limit of normalXx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 3 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 3.0 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 3 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (unless elevated bilirubin is due to Gilbert’s syndrome or of non-hepatic origin)Xx_NEWLINE_xXBilirubin =< 3 x upper limit of normalXx_NEWLINE_xXTotal bilirubin < 1.5 x the upper limit of normal; patients who have been diagnosed with Gilbert's disease are allowed to exceed the defined bilirubin value of 1.5 x the upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal range (ULN)Xx_NEWLINE_xXTotal bilirubin =< 3 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXWithin 28 days prior to signing consent: Total bilirubin > upper limit of normal (ULN) (unless the patient has documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXDirect bilirubin > 2 x upper limit of normal (ULN)Xx_NEWLINE_xXSerum total bilirubin =< 2 x upper limit of normal value (ULN)Xx_NEWLINE_xXBilirubin > 1.5 × upper limit of normal (CTCAE grade 2)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXIron (Fe) phosphatase =< 5 x upper limit of normal and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysisXx_NEWLINE_xXTotal bilirubin =< 1.5 × institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of institutional normalXx_NEWLINE_xXTotal bilirubin =< 2 × institutional upper limit of normal (ULN) and/or history of Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXWithin 30 days of eligibility confirmation: Total bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXMeasured within 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< 3 x normalXx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (=< 3 x institutional ULN in patients with Gilbert's syndrome)Xx_NEWLINE_xXObtained within 28 days prior to registration: Bilirubin =< 1.5 x upper limit of normal (ULN) (subjects with known Gilbert’s disease should have a serum bilirubin =< 3 x ULN)Xx_NEWLINE_xXTotal bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndromeXx_NEWLINE_xXBilirubin > 1.5 x upper limit of normal (ULN) unless with Gilberts syndrome orXx_NEWLINE_xXTotal bilirubin < 1.5 x the upper limit of normal; patients who have been diagnosed with Gilbert’s disease are allowed to exceed the defined bilirubin value of 1.5 x the upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 × institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin =< upper limit of institutional normalXx_NEWLINE_xXTotal bilirubin less than the upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin within 1.5 x institutional level of normal or direct bilirubin =< upper limit of normal (ULN) for patient with total bilirubin levels > 1.5 ULN)Xx_NEWLINE_xXTotal bilirubin <1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, <3x the upper limit of normalXx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN) (unless Gilbert’s is suspected)Xx_NEWLINE_xXBilirubin > 1.5 x (upper limit of normal [ULN]) obtained < 2 weeks prior to study enrollmentXx_NEWLINE_xXBilirubin > 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin > 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXBilirubin > 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin > 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXBilirubin > 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal for age (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless known Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional upper limit of normal (ULN); if total bilirubin is > 2 x ULN, the direct bilirubin must be normalXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (within 14 days of study registration)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the institutional upper limit of normal (IULN) for ageXx_NEWLINE_xXTotal bilirubin =< 1.5x upper limit of normal (ULN) (or if =< 4 gm/dL and direct bilirubin is within normal limits [WNL])Xx_NEWLINE_xXTotal bilirubin below upper limit of normalXx_NEWLINE_xXDirect bilirubin ? 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal Bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin < 2 X institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN)Xx_NEWLINE_xXTotal bilirubin level =< 1 x the upper limit of normal (ULN) rangeXx_NEWLINE_xXBilirubin =< 1.5 x normalXx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normalXx_NEWLINE_xXTotal bilirubin =< 1.25 x the institutional upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome are excluded from this requirementXx_NEWLINE_xXSerum bilirubin ? 1.5 x ULN (upper limit of normal).Xx_NEWLINE_xXTotal bilirubin must be <=1.5*the upper limit of normal (ULN).Xx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXBilirubin ?1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXtotal bilirubin ? 1.5 X institutional upper normal limit (UNL),Xx_NEWLINE_xX