Serum creatinine =< 2 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 times ULNXx_NEWLINE_xXSerum creatinine =< 2 x ULNXx_NEWLINE_xXCreatinine < 1.5 x ULNXx_NEWLINE_xXSerum or plasma creatinine =< 1.5 x ULN measured within 28 days prior to randomizationXx_NEWLINE_xXSerum creatinine < 1.5 x ULN; the values must be obtained within 48 hours prior to randomizationXx_NEWLINE_xXCreatinine =< 1.5 x ULN obtained =< 21 days prior to registrationXx_NEWLINE_xXCreatinine =< 1.5Xx_NEWLINE_xXCreatinine ? 2.0x ULNXx_NEWLINE_xXcreatinine <1.5 × institutional ULN ORXx_NEWLINE_xXSerum creatinine =< 2.5 times ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine less than 1.5 times the ULNXx_NEWLINE_xXRenal insufficiency with serum creatinine > 1.6Xx_NEWLINE_xXCreatinine (Creat) =< 1.5 X ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN (for treatment phase)Xx_NEWLINE_xXCreatinine < 3×ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULN (=< 28 days prior to registration)Xx_NEWLINE_xXRenal insufficiency as indicated by a creatinine level >3 times ULNXx_NEWLINE_xXSerum creatinine ? 2.0 × ULNXx_NEWLINE_xXSerum creatinine =< 2 times ULN; timeline: within 3 weeks prior to enrollmentXx_NEWLINE_xXWithin 30 days prior to enrollment: Creatinine less than 1.5 times the ULNXx_NEWLINE_xXCreatinine ? 1.5 × ULN.Xx_NEWLINE_xXCreatinine ?1.5 ULN.Xx_NEWLINE_xXSerum creatinine =< 1.5 ULNXx_NEWLINE_xXCreatinine ? 1.5 ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXRenal: Serum creatinine ? 1.5 times ULN.Xx_NEWLINE_xXCreatinine =< 2.0 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine =< 2 X institutional ULN (documented within 28 days of registration)Xx_NEWLINE_xXSerum creatinine =< 1.5 x the IULNXx_NEWLINE_xXCreatinine =< 2 x ULN obtained =< 14 days prior to registrationXx_NEWLINE_xXCreatinine ?1.5 ULN ORXx_NEWLINE_xXSerum creatinine =< 1.5 x institutional ULNXx_NEWLINE_xXHave a serum creatinine ?1.5 × ULN.Xx_NEWLINE_xXCreatinine ? 1.5 x ULNXx_NEWLINE_xXCreatinine ?1.5 ULN.Xx_NEWLINE_xXSerum creatinine =< 1.5 x institutional ULNXx_NEWLINE_xXENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Creatinine =< 1.5 X the institutional ULN ORXx_NEWLINE_xXEXPANDED ACCESS COHORT: Serum creatinine =< 1.5 x institutional ULN ORXx_NEWLINE_xXCreatinine clearance < 1.5 x institutional ULNXx_NEWLINE_xXSerum creatinine =< 2.0 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x institutional ULNXx_NEWLINE_xXCreatinine =< 1.5 x within normal institutional ULN ORXx_NEWLINE_xXSerum creatinine =< 1.5 x institutional ULN ORXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 2.5 times ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN, ORXx_NEWLINE_xXCreatinine =< 2.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x institutional ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x institutional ULN within 14 days prior to start of protocol therapy.Xx_NEWLINE_xXSerum creatinine =< 1.5 x institutional ULNXx_NEWLINE_xXSerum creatinine < 2 x ULNXx_NEWLINE_xXSerum creatinine < 2.5 times ULNXx_NEWLINE_xXRenal: creatinine ? 2x of ULN for ageXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXOBTAINED =< 7 DAYS PRIOR TO REGISTRATION: Creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 2 x ULN =< 28 days prior to registrationXx_NEWLINE_xXAbnormal renal function (serum creatinine > 2 x ULN)Xx_NEWLINE_xXSerum creatinine =< 2 x ULNXx_NEWLINE_xXAcceptable renal function: *Serum creatinine ? 1.5 times the ULN.Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine up to 1.5 x ULN.Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x institutional ULNXx_NEWLINE_xXCreatinine =< 2 X institutional ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine > 1.5 x ULNXx_NEWLINE_xXCreatinine < 1.5 times ULN.Xx_NEWLINE_xXObtained =< 14 days prior to registration: Creatinine =< 1.5 x ULNXx_NEWLINE_xXRenal function: serum creatinine ? 1.5 times the ULN range of each institution.Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 2 x ULNXx_NEWLINE_xXSerum creatinine =< 2 x the ULNXx_NEWLINE_xXCreatinine < 2Xx_NEWLINE_xXRenal: Serum creatinine < 2.0 x ULN or creatinine clearance ? 50 mL/min/1.73m^2 for patients with serum creatinine levels above 2 x ULN.Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 2.5 X ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXObtained =< 14 days prior to registration: Creatinine =< 1.5 x ULN ORXx_NEWLINE_xXSerum creatinine ? 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 2.5Xx_NEWLINE_xXSerum creatinine ? 2.5Xx_NEWLINE_xXSubjects above specific amount of serum creatinine.Xx_NEWLINE_xXWithin 7 days (+ 3 day window) of enrollment: Serum creatinine of =< 1.5 x institutional ULNXx_NEWLINE_xXREP ELIGIBILITY: Serum creatinine of =< 1.5 x institutional ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN (results within 7 days before study drug administration)Xx_NEWLINE_xXCreatinine < 1.5 X baseline, < 1.5 X ULN ORXx_NEWLINE_xXCreatinine =< 2.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 times ULNXx_NEWLINE_xX(For both cohorts A and B): Serum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine ? 1.5x ULN;Xx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN ORXx_NEWLINE_xXCreatinine ? 1.5x institutional ULNXx_NEWLINE_xXSerum creatinine =< 1.5 ULNXx_NEWLINE_xXCreatinine =< 1.2 x ULN prior to biopsyXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine > 1.5 ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine =< ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x institutional ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULN ORXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULN obtained =< 14 days prior to registrationXx_NEWLINE_xXRenal function: Creatinine ? 2.0 × ULNXx_NEWLINE_xXSerum creatinine ?1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 times ULNXx_NEWLINE_xXCreatinine < 1.5 times ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 X ULN (CTCAE grade 1 baseline)Xx_NEWLINE_xXCreatinine =< 1.5 times ULNXx_NEWLINE_xXObtained within 14 days prior to registration; serum creatinine ? 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 X ULNXx_NEWLINE_xXCreatinine =< 1.5 x institutional ULN ORXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine ? 1.5 × ULNXx_NEWLINE_xXRenal function (creatinine <1.5 × ULN)Xx_NEWLINE_xXRenal function (creatinine <1.5 × ULN)Xx_NEWLINE_xXWithin 14 days prior to registration: Serum creatinine < 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 3 x ULN for ageXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine < 2.0 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum Creatinine < 2.5 X ULNXx_NEWLINE_xXCreatinine serum levels ? 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN (CTCAE grade 1 baseline)Xx_NEWLINE_xXCreatinine < or = 2Xx_NEWLINE_xXPRIOR TO CELL PROCUREMENT: Serum creatinine ? 1.5 times ULNXx_NEWLINE_xXCreatinine < 1.5 x ULNXx_NEWLINE_xXSerum creatinine > 1.5 x ULNXx_NEWLINE_xXCreatinine > 1.5 x ULNXx_NEWLINE_xXDemonstrate adequate organ function as defined: Absolute neutrophil count (ANC) ?1,500 /mcL Platelets ?100,000 / mcL Hemoglobin ?9 g/dL or ?5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ?1.5 X upper limit of normal (ULN) OR ?60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Serum total bilirubin ? 1.5 X ULN OR Direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ? 2.5 X ULN OR ? 5 X ULN for subjects with liver metastases Albumin >2.5 mg/dLXx_NEWLINE_xXPHASE II: Creatinine < 1.5 x the institutional ULNXx_NEWLINE_xXSerum creatinine =<1.5 times the ULN orXx_NEWLINE_xXCreatinine up to 1.5 ULN, orXx_NEWLINE_xXCreatinine > 1.5 ULN, orXx_NEWLINE_xXCreatinine =< 2.0Xx_NEWLINE_xXSerum creatinine ?1.5 x ULNXx_NEWLINE_xXCreatinine less than 1.5 x ULN (CTCAE Grade 1)Xx_NEWLINE_xXWithin 14 days prior to study entry: Serum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine (Cr) < 2.0Xx_NEWLINE_xXSerum creatinine < 3 x IULNXx_NEWLINE_xXKidney function: creatinine < 2.5 x ULN.Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine > 2.0 x ULNXx_NEWLINE_xXCreatinine < 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXHas serum creatinine < 1.5 × ULNXx_NEWLINE_xXCreatinine =< 2 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.3Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN, obtained =< 14 days prior to registrationXx_NEWLINE_xXSerum creatinine performed within 4 weeks prior to study entry must be less than or equal to 1.5 x ULN for the lab.Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5Xx_NEWLINE_xXCreatinine =< 2.0Xx_NEWLINE_xXSerum creatinine < or = to 2.5 x ULNXx_NEWLINE_xXCreatinine =<1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 2.5 times ULN, ORXx_NEWLINE_xXCreatinine =< 1.5 x ULN (obtained =< 7 days prior to registration)Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine < 2 x ULNXx_NEWLINE_xXSerum creatinine =< 3 x ULN for ageXx_NEWLINE_xXCreatinine =< 1.5 times ULNXx_NEWLINE_xXCreatinine < 2.5 x ULNXx_NEWLINE_xXSorafenib\r\n* Creatinine (Crt) < 1.5 X ULNXx_NEWLINE_xXSerum creatinine < 1.5 times the institutional ULNXx_NEWLINE_xXPatients must have adequate Hematologic function(ANC ? 1,500/mcl and platelets ? 100,000/mcl), Renal function(serum creatinine ? ULN or calculated creatinine clearance ? 60 mL/min), Hepatic function(serum bilirubin ? 1.5 x ULN and AST ? 2.5 x ULN and ALT? 2.5 x ULN)Xx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine (Cr) < 2.0Xx_NEWLINE_xXSerum creatinine =< 2.0 x local institutional ULNXx_NEWLINE_xXSerum creatinine < 1.5 x institutional ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 2.0Xx_NEWLINE_xXSerum creatinine < 2.0Xx_NEWLINE_xXRenal function: Serum creatinine >1.5x ULNXx_NEWLINE_xXCreatinine < 1.8Xx_NEWLINE_xXRenal: Serum creatinine < 1.5 x ULN or creatinine clearance ?60 mL/min/1.73m2 for patients with serum creatinine levels above 1.5 x ULN.Xx_NEWLINE_xXcreatinine ? 1.5 × ULN,,Xx_NEWLINE_xXSerum creatinine concentration < 1.5 x ULNXx_NEWLINE_xXRenal insufficiency or serum creatinine >1.5 X ULN at screening.Xx_NEWLINE_xXSerum creatinine < 1.5 times ULNXx_NEWLINE_xXTotal serum creatinine ? 1.5 × ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXplasma creatinine less than or equal to 1.5 x institutional ULN ORXx_NEWLINE_xXCreatinine (Cr) =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine ?2.0 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine < 2 X ULNXx_NEWLINE_xXCreatinine > 1.5 x ULN.Xx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 ULNXx_NEWLINE_xXCreatinine =< 1.5 x IULNXx_NEWLINE_xXCreatinine < 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine =< 1.5 times the ULNXx_NEWLINE_xXCreatinine =< institutional ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXWithin 28 days of study registration: Creatinine < 2.0 x the institutional ULNXx_NEWLINE_xXSerum creatinine =< grade 1Xx_NEWLINE_xXPatients must have a total serum bilirubin =< 1.5 x ULN (grade =< 1) and a serum creatinine =< grade 1Xx_NEWLINE_xXCreatinine =< grade 1Xx_NEWLINE_xXCreatinine < 1.5Xx_NEWLINE_xXCreatinine =< 1.5 x ULN ORXx_NEWLINE_xXSerum creatinine < 1.5 x ULN or serum creatinine clearance > 50mL/minXx_NEWLINE_xXCreatinine < 2.0Xx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULN, obtained =< 14 days prior to registration ORXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x the institutional ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine > 2 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 2.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 2.0 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine < 2 x the institutional ULNXx_NEWLINE_xXCreatinine =< 2.0 x ULNXx_NEWLINE_xXSerum creatinine < 2 x the institutional ULN; however, if serum creatinine > 1.5 x ULN, a 24 hour urine creatinine clearance must be > 50 ml/min unless there is renal involvement by lymphomaXx_NEWLINE_xXCreatinine < 1.5Xx_NEWLINE_xXSerum creatinine =< 2Xx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine < 2.0Xx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 2 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x IULNXx_NEWLINE_xXCreatinine =< 1.5 times ULNXx_NEWLINE_xXCreatinine [Cr] < 2.0Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXRenal: Creatinine > 1.5x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULN ORXx_NEWLINE_xXSerum creatinine ? 1.5 X ULN (CTCAE Grade 1 baseline)Xx_NEWLINE_xXRenal: Creatinine > 1.5x ULN.Xx_NEWLINE_xXSerum creatinine > 2.5 × ULN. MDS Cohort:Xx_NEWLINE_xXRenal: Creatinine > 1.5x ULNXx_NEWLINE_xXCreatinine < 2.0 × ULNXx_NEWLINE_xXSerum creatinine performed within 28 days of randomization must be less than or equal to 1.5 x ULN for the lab.Xx_NEWLINE_xXSUB-PROTOCOL AIM A: Serum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine at least 1.5 × ULNXx_NEWLINE_xXCreatinine <1.5 X institutional ULN ORXx_NEWLINE_xXRenal: Serum creatinine ? 1.5 x ULN, or for patients with serum creatinine > 1.5 ULN, creatinine clearance ? 50 mL/min.Xx_NEWLINE_xXCreatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine =< 2 x ULNXx_NEWLINE_xXSerum creatinine =< 2 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN, obtained within 14 days prior to initiation of study treatmentXx_NEWLINE_xXSerum creatinine > 1.5 x ULNXx_NEWLINE_xXS-creatinine and S-bilirubin ? 1.5 x ULN. S-ALAT and S-ASAT ? 2.5 x ULN (or ?5 in case of liver metastases)Xx_NEWLINE_xXSerum creatinine ? 1.5 x ULNXx_NEWLINE_xXSerum creatinine equal to or less than 1.5 x ULNXx_NEWLINE_xXCreatinine ? 2.5 x ULNXx_NEWLINE_xXRenal function: • Creatinine less than or equal to 1.5 x ULNXx_NEWLINE_xXCreatinine <= 1.5 x ULN.Xx_NEWLINE_xXCreatinine < or equal to 1.5 x ULNXx_NEWLINE_xXRenal: Serum creatinine 1.5 times ULN.Xx_NEWLINE_xXCreatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine < 2.0Xx_NEWLINE_xXSerum creatinine < 1.5 times ULNXx_NEWLINE_xXCreatinine =< 1.5Xx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum Creatinine ? 1.5X ULNXx_NEWLINE_xXSerum creatinine < 3 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULN for ageXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 2.0 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine < 2 X ULNXx_NEWLINE_xXCreatinine less than 1.5 x ULNXx_NEWLINE_xXSerum creatinine ? 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULN (within 7 days prior to registration)Xx_NEWLINE_xXCreatinine > 1.5 x ULNXx_NEWLINE_xXWithin 4 weeks of administration of study therapy: Serum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine 1.5 x ULNXx_NEWLINE_xXRenal insufficiency as indicated by a creatinine level > 2 x the ULN.Xx_NEWLINE_xXCreatinine =< 1.5 X ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine ? 1.5 × ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN (obtained =< 7 days prior to randomization)Xx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine level =< IULNXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 X ULNXx_NEWLINE_xXCreatinine (Cr) < 3Xx_NEWLINE_xXSerum creatinine > 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine ?1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCOHORT B: Creatinine =< 2.0 x ULNXx_NEWLINE_xXSerum creatinine ? 2.0 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine ? 1.5 × ULNXx_NEWLINE_xXSerum creatinine performed within 4 weeks prior to study entry must be less than or equal to 1.5 x ULN for the lab.Xx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< ULN x 1.5Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine =< 2 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x institutional ULNXx_NEWLINE_xXSerum creatinine =< 1.5 X institutional ULNXx_NEWLINE_xXObtained =< 7 days prior to registration: Creatinine =<1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine >= 2.0Xx_NEWLINE_xXObtained =< 7 days prior to registration: Creatinine =< 1.5 x institutional ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 2.0 x ULNXx_NEWLINE_xXCreatinine < 1.5 X institutional ULNXx_NEWLINE_xXSerum creatinine < 1.5 time the institutional ULNXx_NEWLINE_xXSerum creatinine less than or equal to 2 x ULNXx_NEWLINE_xXCreatinine < 1.5Xx_NEWLINE_xXCreatinine < 2.0Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 2 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULN ORXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 X ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine concentration =< 2 x ULNXx_NEWLINE_xXCreatinine =< 2.5 x ULNXx_NEWLINE_xXCreatinine < 2 x ULNXx_NEWLINE_xXSerum creatinine concentration <2x ULNXx_NEWLINE_xXCreatinine =< 1.7Xx_NEWLINE_xXSerum creatinine ? 1.5 x ULNXx_NEWLINE_xXWithin 8 weeks of randomization: Serum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 x of ULNXx_NEWLINE_xXCreatinine < 2 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 2.0 x ULNXx_NEWLINE_xXCreatinine 1.5 x ULNXx_NEWLINE_xXSerum creatinine >1.5x ULN at screeningXx_NEWLINE_xXSerum Creatinine < 2.0 times the institutional ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine (Cr) =< 2.0Xx_NEWLINE_xXCreatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine less than 1.5Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) of >= 30Xx_NEWLINE_xXSerum creatinine =< 2 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXPatients with baseline creatinine kinase (CK) > ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine ? 1.5 x ULNXx_NEWLINE_xXSerum creatinine ? 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine =< 2.0 X ULNXx_NEWLINE_xXSerum creatinine</=1.5 times the ULNXx_NEWLINE_xXCreatinine < 1.5 x ULNXx_NEWLINE_xXSerum creatinine ? 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULN or creatinine (Cr) > 1.5 x ULN, but calculated clearances of > 60Xx_NEWLINE_xXCreatinine >2.0x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN or creatinine (Cr) > 1.5 x ULN, but calculated clearances of > 60Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN for the labXx_NEWLINE_xXCreatinine =< 1.5 x institutional ULNXx_NEWLINE_xXCreatinine =< 2 X ULNXx_NEWLINE_xXCreatinine =< 1.5 X ULNXx_NEWLINE_xXSerum creatinine < 2.0 x ULNXx_NEWLINE_xXRenal function: creatinine ? 1.5 x ULNXx_NEWLINE_xXCreatinine > 1.5 × ULNXx_NEWLINE_xXSerum creatinine =< 2 times ULNXx_NEWLINE_xXSerum creatinine (sCr) ? 1.5 x ULN;Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine > 1.5 x ULN.Xx_NEWLINE_xXCreatinine (Cr) > 2.5Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine ? 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine (renal function) =< 1.5 X ULNXx_NEWLINE_xXCreatinine =< 1.5 x Institutional ULN obtained =< 7 days prior to registrationXx_NEWLINE_xXSerum creatinine < 2 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 × ULNXx_NEWLINE_xXserum creatinine ?1.5 X ULNXx_NEWLINE_xXSerum creatinine ?1.5 ULN.Xx_NEWLINE_xXCreatinine =< ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXCreatinine < 3 x ULNXx_NEWLINE_xXCreatinine < 2.0Xx_NEWLINE_xXCreatinine > 2.0Xx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 2 x ULNXx_NEWLINE_xXPatients with creatinine more than 1.5 x the ULNXx_NEWLINE_xXCreatinine >= 1.5 times ULNXx_NEWLINE_xXCreatinine less than 2.5 X ULNXx_NEWLINE_xXRenal: Serum creatinine less than or equal to 1.5 times ULN.Xx_NEWLINE_xXCreatinine =< 1.5 X ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 2 X ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 2 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXUrea and serum creatinine < 2.5 times ULNXx_NEWLINE_xXSerum creatinine =< 1.5 times the ULNXx_NEWLINE_xXSerum creatinine < 2 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine > 1.5 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 X ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine < 2.0 x ULNXx_NEWLINE_xXObtained within 14 days prior to initiation of treatment: Serum creatinine =< 1.5 times ULNXx_NEWLINE_xXSerum creatinine >= 2.5 x ULN 14 days prior to study enrollmentXx_NEWLINE_xXCreatinine > 2.0Xx_NEWLINE_xXCreatinine =< 1.2 X ULN obtained =< 180 days prior to registrationXx_NEWLINE_xXSerum creatinine =< 1.5 x the ULNXx_NEWLINE_xXSerum creatinine > 2.0Xx_NEWLINE_xXSerum creatinine greater than 3.0Xx_NEWLINE_xXSerum creatinine =< 2Xx_NEWLINE_xXSerum creatinine =< 2.0 x IULNXx_NEWLINE_xXCreatinine =< 2 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x ULNXx_NEWLINE_xXDONOR: Total creatinine kinase > 2 times the ULNXx_NEWLINE_xXCreatinine =< 1.3Xx_NEWLINE_xXSerum creatinine =< 1.5 times institutional ULNXx_NEWLINE_xXCreatinine =< 1.5 x institutional ULNXx_NEWLINE_xXCreatinine < 2 x ULNXx_NEWLINE_xXCreatinine =< 1.5 x institutional ULNXx_NEWLINE_xXCreatinine =< 1.5Xx_NEWLINE_xXCreatinine =< ULNXx_NEWLINE_xXCreatinine =< 1.5 x institutional ULNXx_NEWLINE_xXSerum creatinine < 2 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine < 2.0Xx_NEWLINE_xXSerum creatinine =< 1.5 times ULNXx_NEWLINE_xXDONOR: Total creatinine kinase > 2 times the ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXCreatinine < 2 x ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x institutional ULNXx_NEWLINE_xXCreatinine kinase =< 2.5 x the ULN, within 30 days prior to enrollmentXx_NEWLINE_xXSerum creatinine =< institutional ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXSerum creatinine ? 1.5 x ULNXx_NEWLINE_xXSerum creatinine within 1.5 times the institution’s ULNXx_NEWLINE_xXCreatinine within 2 x ULNXx_NEWLINE_xXPlasma creatinine =< 1.6Xx_NEWLINE_xXSerum creatinine < 2.0Xx_NEWLINE_xXCreatinine (Cr) > 2.0Xx_NEWLINE_xXCreatinine > 2.0 x ULNXx_NEWLINE_xXCreatinine (Cr) =< 1.5Xx_NEWLINE_xXPatients with a history of renal disease or patients over 70 with a creatinine > 1.3; creatinine must have been done within the last 12 weeksXx_NEWLINE_xXRenal function: serum creatinine ?1.5 times the ULN range of each institution.Xx_NEWLINE_xXCreatinine <1.5 X ULNXx_NEWLINE_xXElevated serum creatinine of > 2Xx_NEWLINE_xXRenal lab values: Creatinine > 1.5 ULNXx_NEWLINE_xXCreatinine < ULN, performed within 28 days prior to registrationXx_NEWLINE_xXCreatinine < 2 X institutional ULNXx_NEWLINE_xXSerum creatinine =< 1.5 x ULNXx_NEWLINE_xXGreater than 1.5 x the ULN for creatinineXx_NEWLINE_xXSerum creatinine =< within 1.5 x ULNXx_NEWLINE_xXCreatinine < 1.2Xx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xXCreatinine >1.5 x ULNXx_NEWLINE_xXSerum creatinine < 1.5 x ULNXx_NEWLINE_xX