Within 6 weeks prior to randomization: Aspartate aminotransferase (AST) must be =< 1.5 x ULN for the lab\r\n* Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 1.5 x ULN; if both were performed, the AST must be =< 1.5 x ULN
Re-registration: AST/ALT =< 3 x ULN
AST/ALT ?2.5 × ULN
Serum AST and ALT ? 3 X ULN
AST and ALT must be less than or equal to 2.5 x ULN for the lab with the following exception: for patients with documented liver metastases, AST and ALT must be less than or equal to 5 x ULN.
AST or ALT > 2.5 × ULN. For patients with liver metastasis AST or ALT > 5 × ULN.
Serum ALT and AST levels ?2.5 x ULN
AST and ALT are each ?5 × the ULN;
Chronic hepatitis B as defined below or elevated AST, ALT > 3 ULN
AST and ALT ? 5 x ULN
AST and ALT must be ? 1.5 x ULN for the lab.
Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3.0 x ULN; for patients with hepatic metastases, ALT and AST =< 5.0 x ULN are acceptable\r\n* Note: if a patient experiences elevated ALT > 5 x ULN and elevated total bilirubin > 2 x ULN, clinical and laboratory monitoring should be initiated by the investigator; for patients entering the study with ALT > 3 x ULN, monitoring should be triggered at ALT > 2 x baseline
Serum AST and/or ALT < 3 x institutional ULN.
ALT and AST ? 3 × ULN
ALT and AST ? 1.5 ULN
AST or ALT > 2.5 × ULN. For patients with liver metastasis AST or ALT > 5 × ULN
PHASE IB: Transaminases (AST and/or ALT) =< 2.5 x ULN
ALT/AST ? 2 times ULN
AST or ALT > 2.5 x ULN; for patients with liver metastasis AST or ALT > 5 x ULN
ALT and AST ?2.5 x ULN
ALT or AST greater than 3.0 times the ULN in the presence of known hepatic metastases
COHORT 3: ENDOMETRIAL CANCER: AST and ALT levels =< 3 X ULN
Serum ALT/AST ? 2.5 x ULN
Bilirubin >2.0; alkaline phosphatase >5x upper limit of normal (ULN); ALT/AST >2x ULN. For patients with hepatic metastases, ALT/AST >5x ULN is exclusionary.
AST and ALT with hepatic metastasis =< 5 x ULN
ALT ?3 x ULN
AST/ ALT ? 2.5x institutional ULN
AST and ALT <2.5 x ULN
Prior ALT-803
Cabazitaxel: AST =< 1.5 x ULN
AST and ALT>5xULN
Serum ALT/AST ? 2.5 ULN
Grade 4 AST or ALT elevation
AST and ALT ? 3 x ULN
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase must be within the range allowing for eligibility at cycle 1 day 1 of TPF:\r\n* Alkaline (Alk) Phosphate (PHOS) =< upper limit of normal (ULN); AST or ALT =< ULN: Eligible\r\n* ALK PHOS =< ULN; AST or ALT > 1x but =< 1.5x: Eligible\r\n* ALK PHOS =< ULN; AST or ALT > 1.5x but =< 5x: Eligible\r\n* ALK PHOS =< ULN; AST or ALT > 5x ULN: Ineligible\r\n\r\n* ALK PHOS > 1x but =< 2.5x; AST or ALT >1x but =< 2.5x; AST or ALT =< ULN: Eligible\r\n* ALK PHOS > 1x but =< 2.5x; AST or ALT > 1x but =< 1.5x: Eligible\r\n* ALK PHOS > 1x but =< 2.5x; AST or ALT > 1.5x but =< 5x: Ineligible\r\n* ALK PHOS > 1x but =< 2.5x; AST or ALT > 5x ULN: Ineligible\r\n\r\n* ALK PHOS > 2.5x but =< 5x; AST or ALT =< ULN: Eligible \r\n* ALK PHOS > 2.5x but =< 5x; AST or ALT > 1x but =< 1.5x: Ineligible\r\n* ALK PHOS > 2.5x but =< 5x; AST or ALT > 1.5x but =< 5x: Ineligible\r\n* ALK PHOS > 2.5x but =< 5x; AST or ALT > 5x ULN: Ineligible\r\n\r\n* ALK PHOS > 5 ULN; AST or ALT =< ULN: Ineligible\r\n* ALK PHOS > 5 ULN; AST or ALT > 1x but =< 1.5x: Ineligible\r\n* ALK PHOS > 5 ULN; AST or ALT > 1.5x but =< 5x: Ineligible\r\n* ALK PHOS > 5 ULN; AST or ALT > 5x ULN: Ineligible
AST and ALT < 2.5 x ULN
ALT or AST > 1.5 ULN in patients (pts) without liver metastasis
For pts with liver metastasis: ALT or AST > 2.5 ULN
AST or ALT > 2.5 x ULN
Aspartate aminotransaminase (AST), alanine aminotransaminase (ALT) within 2.5 x institutional upper limits of normal unless there are liver metastases in which case AST and ALT within 5.0 x ULN
Serum ALT, AST ? 2 × ULN
AST or ALT > 3 times ULN, AST or ALT > 5 times ULN for patients with liver metastases.
PHASE II: AST and ALT < 3 x ULN
AST and ALT <3 x ULN
ALT and AST ? 1.5 ULN
Inotuzumab within 30 days and must have ALT, AST and bilirubin < ULN.
ARM C COHORT 4: AST and ALT =< 5 x ULN
AST/ALT =<3 X ULN; -Bilirubin =<1.5 X ULN, unless resulting from hemolysis
AST < 3.0 x ULN
ALT < 3.0 x ULN
AST and ALT must be less than or equal to 2.5 x ULN for the lab with the following exception: for patients with documented liver metastases, AST and ALT must be less than or equal to 5 x ULN.
AST and ALT ? 1.5 x ULN
AST and ALT <3.0 x ULN
EXCLUSION CRITERIA FOR TREATMENT: AST/ALT greater than or equal to 2.5 x ULN
Chemistry: ALT/AST ? 3.0 x ULN, TBili ?1.5 x ULN, and Cr < 2 mg/dL
Aspartate aminotransferase (AST) must be =< 3 x ULN for the lab within 28 days before randomization;\r\n* Note: if alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 3 x ULN; if both were performed, the AST must also be =< 3 x ULN; if AST and/or ALT is >= ULN but =< 3 x ULN, serologic testing for hepatitis B and C must be performed and results for viral infection must be negative
AST or ALT less than or equal to 2.5 X institutional ULN
AST/ALT < 2.5 x ULN
AST/ALT =< 2.5 x ULN
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALK PHOS) must be within the range of eligibility as noted below:\r\n* AST or ALT =< 5 x ULN and ALK PHOS =< ULN\r\n* AST or ALT =< 1.5 x ULN and ALK PHOS =< 2.5 x ULN\r\n* AST or ALT =< ULN and ALK PHOS =< 5 x ULN
ALT or AST <3 x ULN
Subjects who have BOTH bilirubin greater than ULN and AST/ALT greater than 1.0 x ULN are not eligible
AST <3 × ULN
MF PATIENTS: ALT/AST =< 2.5 x ULN
Asparate aminotransferase (AST) and alanine aminotransferase (ALT) must be less than or equal to 2 x ULN for the lab. (Note: If AST and/or ALT greater than ULN, serologic testing for Hepatitis B and C must be performed and results must be negative.)
AST =< 5.0 x ULN or ALT =< 5.0 x ULN is acceptable if liver has tumor involvement; (Note, if both AST and ALT are done, both must be =< 5.0 x ULN)
ALT and AST ?3 x ULN or ?5 x ULN if known hepatic metastases.
AST and/or ALT >3 x ULN
ALT and AST less than or equal to 3 x ULN
AST/ALT ? 5X ULN [with underlying Liver Metastasis]
AST and ALT ? 3.0 x ULN
AST and ALT ?2.5 × institutional ULN. Patients enrolled in an expansion stage may have ALT and AST <5 × institutional ULN if the patient has hepatic metastases.
Serum ALT/AST ? 2.5 x ULN
ALT > 3 x ULN
AST > 3 x ULN
AST, ALT must be <2 x ULN.
ALT or AST > 2.5 ULN in patients (pts) without liver metastasis; for pts with liver metastasis: ALT or AST > 5 x ULN
AST or ALT > 5 x ULN
AST/ALT: ? 2.5 x ULN
AST or ALT ?2.5 x ULN
AST/ALT ? 1.5 × ULN
ALT and AST ? 3.0 x ULN (subjects with known liver metastases may have AST and ALT ? 5.0 x ULN)
AST level ?2.5 x ULN and ALT ? 2.5 × ULN. For patients with liver metastases, AST ?3.5 x ULN, and AST ?3.5 x ULN may be enrolled if agreed upon by the investigator and medical monitor for the sponsor.
COHORT B: AST/ALT =< 2.5 x ULN
AST and ALT < 2.5 x ULN
AST and ALT no greater than 1.5 times ULN
Subjects who have both bilirubin > ULN and AST/ALT > ULN
Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN not permitted
ALT<2x ULN
Aspartate aminotransferase (AST) ?2.5 x ULN; ALT ?2.5 x ULN or AST/ALT <5 x ULN if liver involvement
AST and ALT ? 2 x ULN
AST/ALT < 3.0 x ULN
AST/ALT < 3.0 x ULN
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: AST/ALT < 3.0 x ULN
ALT or AST > 3.5 x ULN at screening
AST and ALT must be ? 5 x Upper Limit of Normal (ULN) if this elevation is solely due to ASM/MCL, otherwise AST, ALT must be ? 2.5 x ULN
Serum AST and ALT ? 3 x ULN;
ALT ? 5x ULN of normal for age.
Patients with ALT > 10x ULN at screening.
AST and ALT 3.0 ULN with the following exception: Patients with liver involvement: AST and/or ALT 5 ULN
AST and/or ALT >= 3 times the ULN
For patients with tumor involvement of the liver AST or ALT > 5 x ULN
Serum AST or ALT ? 1.2 x ULN
Serum ALT/AST <2.5 ULN
Patients with AST/ALT > ULN must have negative hepatitis studies
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 x ULN, unless ALT or AST elevation is thought to be related to underlying AML, in which case ALT and AST should be =< 5.0 x ULN
AST or ALT > 2.5 × ULN. For patients with liver metastasis, AST or ALT > 5 × ULN
ALT and AST ? 2.0 x ULN
AST and ALT ? 2.5 X ULN
ALT and AST > 2.5×ULN. For patients with documented liver metastases, ALT and AST > 5×ULN.
ALT and AST < 3 x ULN (unless attributed to leukemic involvement)
Serum Bilirubin ? ULN, AST and ALT ? ULN
AST and ALT ? 3 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ? 5 x ULN.
AST or ALT > 3× the ULN for the institution (> 5× ULN if due to hepatic involvement by tumor)
AST & ALT ? 2.5 x ULN
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALK PHOS) must be within the range allowing for eligibility:\r\n* ALK PHOS =< ULN AND AST or ALT =< 1.5 X ULN\r\n* ALK PHOS > 1 X ULN but =< 2.5 ULN AND AST or ALT =< 1.5 X ULN\r\n* ALK PHOS > 2.5 X ULN but =< 5 X ULN AND AST or ALT =< ULN
ALT and/or AST ?2.5 X ULN
ALT and/or AST ?2.5X ULN
ALT and/or AST ?3X ULN
ALT and/or AST ?3X ULN
ALT or AST > 3 x ULN
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and alkaline phosphatase (AP) must be within the range allowing for eligibility:\r\n* AP =< upper limit of normal (ULN) AND AST or ALT > 1 x ULN, but =< 1.5 x ULN\r\n* AP > 1 x ULN, but =< 2.5 x ULN AND AST or ALT > 1 x ULN, but =< 1.5 x ULN\r\n* AP > 2.5 x ULN, but =< 5 x ULN AND AST or ALT =< ULN\r\n* AP > 5 x ULN not eligible
AST and ALT =< 2.5 x ULN
AST and ALT < 2.5 x ULN
AST, ALT, and alkaline phosphatase (AP) must meet one of the following criteria:\r\n* AST or ALT =< 5 times ULN AND AP =< normal\r\n* AST or ALT =< 1.5 times ULN AND AP =< 2.5 times ULN\r\n* AST or ALT =< normal AND AP =< 5 times ULN
Standard safety inclusion for serum creatinine, AST, ALT, bilirubin
AST or ALT < 1.5 times ULN for age
ALT and AST <2.5 × ULN or, in patients with documented hepatic metastasis, ?5.0 × ULN.
ALT and AST ? 3.0 x ULN within 14 days prior to registration
AST, and ALT > 1.5 x ULN
ALT and AST ? 1.5 ULN of institution's range
Prior ALT-803
Patients with a history of liver disease or AST/ALT >= 2.5 times ULN on screening
AST and ALT =< 2.5 X ULN or =< 5 x ULN if liver metastases are present (evaluated within 28 days of randomization); concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN are not permitted
AST/ALT < 3.0 x ULN
ALT > 1.5 x ULN
AST ? 3.0 x ULN
ALT ? 3.0 x ULN
PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: AST (SGOT) / ALT (SGPT): =< 3 x ULN
AST/SGOT and ALT/SGPT ? 2.5 X ULN
COHORT 2: AST (SGOT) and ALT (SGPT) =< 3 X ULN within 14 days of treatment initiation
AST(SGOT)/ALT(SGPT) ? 2.5 X institutional ULN
AST (SGOT) and ALT (SGPT) ? 2.5 x ULN.
RANDOMIZED PHASE II CLINICAL TRIAL: Within 10 days of registration: AST (SGOT) and ALT (SGPT) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases
AST (SGOT) >2x ULN
AST/ALT (SGOT/SGPT) < 2 ULN
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ? 3.0 x upper limit of normal (ULN). In the case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ? 5.0 x ULN.
EXPANDED ACCESS COHORT: AST(SGOT)/ALT(SGPT) =< 2.5 x institutional ULN -OR- AST(SGOT)/ALT(SGPT)\t=< 5 x institutional ULN if liver metastases are present
AST (SGOT)/ ALT (SGPT): ? 3.0 x institutional ULN
AST(SGOT)/ALT(SGPT) for patients with documented liver metastases, =< 5 x institutional ULN
AST (SGOT)/ALT (SGPT) ?2 X ULN; ? 5 X ULN if there is liver involvement secondary to tumor
AST (SGOT) and ALT (SGPT) ? 2.5 x ULN.
AST/SGOT and ALT/SGPT ? 3.0 x ULN
SGPT (ALT) ? 110 U/L and
AST (SGOT) and ALT (SGPT) =< 5 x ULN in patients with documented hepatic involvement by lymphoma
AST (aspartate transaminase or SGOT)/ALT (alanine aminotransferase or SGPT) ? 3.0 x ULN and total bilirubin ? 2.0 x ULN with no evidence of cholestasis
• AST (SGOT) and ALT (SGPT) ? 3 times institutional ULN; if liver metastases are present, then ? 5 times ULN is allowed.
Hepatic impairment, defined as AST (SGOT), or ALT (SGPT) > 2 x institutional ULN, within 21 days of initiation of protocol therapy or
SGOT or SGPT > 4 x ULN
For Part B participants: SGPT (ALT) concentration < 2.5 x institutional ULN
SGPT (ALT) ? 110 U/L.
RETREATMENT WITH MODIFIED T CELLS: ALT (SGPT): =< 5 x ULN
SGPT (ALT) and SGOT (AST) less than or equal to 3 x normal for age
B. Hepatic: Serum total bilirubin ?2.5 x upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) ?2.5 x ULN.
Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ? 3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ? 5 × ULN.
AST (SGOT), ALT (SGPT) and Alkaline phosphatase > 2.5 times ULN
AST / ALT (SGPT) <2.5 x ULN
AST(SGOT)/ALT(SGPT): ?3 x UNL
REGISTRATION TO TREATMENT (STEP 2): AST (SGOT) and ALT (SGPT) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases, within 14 days prior to first dose of pembrolizumab
SGOT (AST) and SGPT (ALT) > 3x institutional ULN
PHASE II: AST (SGOT) and ALT (SGPT) =< 3 times institutional ULN (=< 5 times if LFT elevations due to known liver metastases)
Serum AST/SGOT and ALT/SGPT ? 3.0 x ULN.
Serum AST and ALT/SGPT ? 3.0 x ULN.
AST(SGOT) and ALT(SGPT) <2.5 x ULN
REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: SGOT (AST) or SGPT (ALT) =< 2.5 x IULN
SGOT (AST) ? 3 x ULN
AST (SGOT) and ALT (SGPT): ?2.5xULN OR ?5xULN for subjects with liver metastases
AST (SGOT) and ALT (SGPT) <2 X institutional ULN (for subjects with hepatic metastases <5 X institutional ULN)
AST (SGOT) and ALT (SGPT) ? 3.0 x ULN
AST/SGOT and ALT/SGPT ? 3 x upper limit of normal (ULN) or ? 5.0 x ULN if liver tumor is present.
AST/SGOT and ALT/SGPT ?2.5×ULN
ALT (SGPT) ? 2.5 X ULN for age
AST/SGOT and ALT/SGPT > 3.0 x ULN
AST (SGOT) and ALT (SGPT) ? 2.5 X ULN OR ? 5 X ULN for patients with liver metastases
Hepatic: Serum total bilirubin ?2.5 x upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) ?2.5 x ULN.
AST (SGOT) and ALT (SGPT) ? 3.0 x ULN); if liver metastases are present, then ? 5 x ULN is allowed
SGOT and SGPT >= 5 x ULN; liver biopsy preferred for such patients
Obtained within 2 weeks from study entry: SGOT, SGPT =< 5 X ULN if liver metastasis present
The patient has serum total bilirubin < 2 g/dL (unless the patient has a diagnosis of Gilbert's disease), SGOT (ALT) <3.5×ULN, and SGPT (AST) <3.5×ULN
AST (SGOT) and ALT (SGPT) < = 3 x ULN.
Exception for patients with liver metastasis: ALT (SGPT) =< 8 x ULN
AST (SGOT), ALT (SGPT) ? 5 × ULN is allowed:
AST (SGOT) ? 3 × the ULN;
ALT (SGPT) ? 3 × the ULN;
AST(SGOT)/ALT(SGPT) =< 2.5 X institutional ULN
AST/ALT (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x --ULN in the presence of liver metastases
SELUMETINIB ARM: AST/SGOT or ALT/SGPT > 2.5 x ULN (>= 5 ULN in presence of liver metastases)
AST/SGOT and/or ALT/SGPT > 2.5 x ULN, (> 5 x ULN if liver metastases present)
Serum total bilirubin ? 1.5 x ULN and AST/SGOT and ALT/SGPT ? 2.5 x ULN or ? 5 x ULN if liver metastases are present.
CROSSOVER (STEP 2) REGISTRATION: SGOT (AST) or SGPT (ALT) =< 2.5 x IULN
Total bilirubin ? ULN, SGOT (AST) and SGPT (ALT)< 1.5 x ULN. AST and/or ALT may be up to 5X ULN if with known liver metastases provided bilirubin is normal.
AST(SGOT)/ALT(SGPT) <2.5 X institutional ULN unless due to disease
SGPT (ALT) ? 135 U/L and SGOT (AST) ? 3X ULN. (for the purpose of this study, the upper limit of normal [ULN] for SGPT [ALT] is 45 U/L).
Hepatic function: Serum total bilirubin ? 1.5 x ULN (upper limit of normal); AST (SGOT) and ALT (SGPT) ? 3 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ? 5 x ULN
AST (SGOT) and ALT (SGPT) ? 2.5 x ULN. For subjects with documented liver metastases, ALT and AST ? 5 × ULN
AST/SGOT, ALT/SGPT ?2.5 x ULN, unless liver metastases are clearly present, then ?5.0 x ULN
AST(SGOT)/ALT(SGPT) ?3 X ULN (including patients with liver metastases)
SGOT(AST) and SGPT(ALT) ? 3 x ULN i.e. equivalent to ? Grade 1 NCI-CTCAE v.4.03
Must have total bilirubin ? 1.5 × institutional ULN [? 2.0 x ULN in presence of liver metastases] within 14 days prior to randomization.
Total bilirubin < 1.5 x upper limit of normal (ULN) if no liver metastases or =< 3 times ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinaemia) or liver metastases within 4 weeks before randomization
AST < 2.5 x ULN (5.0 x ULN in the presence of liver metastasis)
ALT < 2.5 x ULN (5.0 x ULN in the presence of liver metastasis).
ALP, ALT, and AST > 3 x ULN (>5 x ULN if subject has liver metastases)
Patients must exhibit adequate bone marrow, liver, and renal function, within 14\r\ndays prior to registration, defined as: \r\n* Absolute neutrophil count (ANC) >= 1,000/mm^3 (growth factor support is permitted)\r\n* Platelets >= 100,000/mm^3 (may be reached by transfusion)\r\n* Hemoglobin >= 10 gm/dl (may be reached by transfusion)\r\n* Glutamate pyruvate transaminase (GPT)/glutamate oxaloacetate transaminase (GOT) < 3 x upper limit of normal (ULN) (or < 5 x ULN in case of liver metastasis)\r\n* Bilirubin < 3 x ULN (or < 5 x ULN in case of liver metastasis)\r\n* Creatinine < 1.5 x ULN
Serum AST/ALT < 3X the upper limit of normal (ULN) for the reference lab (< 5X the ULN for patients with known hepatic metastases)
Has adequate hepatic function, defined as: AST/ALT levels =< 3 x ULN (if liver metastases are present, =< 5 x ULN) Bilirubin =< 1.5 x ULN.
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): AST and ALT: =< 3 x ULN or =< 5 x ULN for patients with liver metastases within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): AST and ALT: =< 3 x ULN or =< 5 x ULN for patients with liver metastases within 2 weeks of registration
Clinically significant (as determined by the investigator) hematological, hepatic and renal dysfunction, defined as: Neutrophil count < 1.5 x 10^9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x ULN; AST and/or ALT > 2.5 x ULN or > 5 x ULN if patient has documented liver metastases; and serum creatinine > 1.5 x ULN
AST ?2.5 x ULN (if liver or bone mets are present, ?5 x ULN)
AST and/or ALT ?2.5× ULN, <5× ULN w/liver metastases
Transaminases =< 3.0 x ULN, except in known hepatic disease, wherein may be =< 5 x ULN
Bilirubin =< 3 X ULN or < 5 X ULN in the presence of liver metastases
Liver Transaminases (ALT/AST) ? 2.5 x ULN, ? 5.0 x ULN if liver metastases present
Obtained =< 14 days prior to registration: Aspartate transaminase (AST) =< 2.5 x ULN or =< 5 x ULN for subjects with liver metastases
Adequate bone marrow and major organ function to undergo a PBSC transplant determined within 30-60 days prior to enrollment using standard phase 1 criteria for organ function defined as:\r\n* Absolute neutrophil count (ANC) >= 1.5 x 10^9 cells/L\r\n* Platelets >= 100 x 10^9/L\r\n* Hemoglobin >= 9 g/dL\r\n* Aspartate and alanine aminotransferases (AST, ALT) =< 2.5 x ULN (=< 5 x ULN, if documented liver metastases are present)\r\n* Total bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)\r\n* Creatinine < 2 mg/dl (or a glomerular filtration rate > 60)
ALT and AST ? 3 x ULN or ? 5 x ULN if documented liver infiltration with leukemia cells
For patients with Hodgkin lymphoma (HL) involvement of the liver, AST/ALT =< 5.0 x institutional ULN; total bilirubin within 3.0 x institutional ULN
Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULN
Demonstrate 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/dL
Adequate hepatic function: bilirubin ?1.5 x upper limit of normal (ULN), AST ?2.5 x ULN, ALT ?2.5 x ULN, alkaline phosphatase (liver fraction) ?2.5 x ULN
Adequate hepatic function with total bilirubin and ALT < 1.5X the upper limit of normal (ULN), except in patients with Gilbert's Syndrome must have a total bilirubin < 3X ULN and ALT < 3X ULN. In cases of known liver metastases, ALT ? 5X ULN is acceptable (total bilirubin must be < 1.5X ULN).
AST and ALT ? 3 x ULN for age unless elevation can be clearly attributed to liver leukemia or metastases
Aspartate transaminase (AST) ?2.5 × ULN, or ?5 × ULN if leukemic infiltration of the liver is present
Patients with abnormal hepatic function will be eligible and will be grouped according to criteria summarized below:\r\n* Group A: Normal hepatic function\r\n** Bilirubin =< ULN\r\n** Aspartate aminotransferase (AST) =< ULN\r\n* Group B: Mild hepatic dysfunction\r\n** B1: bilirubin =< ULN and AST > ULN\r\n** B2: ULN < bilirubin =< 1.5 x ULN and any AST\r\n* Group C: Moderate hepatic dysfunction\r\n** 1.5 x ULN < bilirubin =< 3 x ULN and any AST\r\n* Group D: Severe hepatic dysfunction\r\n** 3 x ULN < bilirubin =< 10 x ULN and any AST; hepatic function tests should be repeated within 24 hours prior to starting initial therapy and may result in patients’ group assignment being altered if different to registration test results
Adequate liver function as defined below: \r\n• Serum Bilirubin < 1.5 x upper limit of normal (ULN) for institution [Exception: Patients who have elevated serum bilirubin due to underlying Gilbert’s Syndrome or familial benign unconjugated hyperbilirubinemia are allowed.] \r\n• AST (SGOT) < 2.5 x upper limit of normal (ULN) for institution (or < 5.0 x ULN in presence of liver metastases) \r\n• ALT (SGPT) < 2.5 x upper limit of normal (ULN) for institution (or < 5.0 x ULN in presence of liver metastases)
Transaminases =< 2 x upper limit of normal (ULN) or if liver metastases were present, =< 3 x ULN
For subjects with liver metastasis, adequate liver function is demonstrated by serum bilirubin =< 2 x ULN and AST/ALT =< 5.0 x ULN
AST and ALT ? 3 x ULN or ? 5 x ULN for subjects with known liver metastases
ALT =< 3 x ULN (5.0 x ULN if considered to be due to leukemic involvement)
Serum transaminases =< 3 x ULN
Total 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 ULN
Adequate liver function, as defined by AST and ALT ? 3 x ULN, and bilirubin ? 1.5 x ULN (unless documented Gilbert's syndrome).
Patients must have adequate hepatic function as evidenced by AST and ALT values ? 3 X ULN (? 5 X ULN if the liver is known to be involved by metastatic disease) and serum total bilirubin values of ? 1.5 X ULN for the reference laboratory.
AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases)
For Phase I and II: Adequate liver (bilirubin </=2x ULN, ALT </=2.5x ULN) and renal (creatinine </=2x ULN) function. For patients with suspected liver infiltration from leukemia ALT should be </= 5 ULN.
Exception for patients with liver metastasis: total bilirubin =< 3 x ULN; ALT (SGPT) =< 8 X ULN
Obtained =< 28 days prior to randomization:\r\nAspartate transaminase (AST) =< 2.5 x ULN (or =< 5 x ULN in presence of liver metastases)
Adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver)
Liver function: bilirubin > 1.5x upper limit of normal (ULN) and SGOT (AST) > 2.5x ULN.
Serum transaminases =< 3X ULN.\r\n* Note: Transaminases can be up to 5 X ULN in the setting of liver metastases.
Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =< 3.0 x ULN and ALT/AST are =< 5.0 x ULN
Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULN.
AST/ALT > 2.5 X ULN or > 5 X ULN in the presence of liver metastases; current treatment with anti-androgen is allowed for a maximum of one month to prevent flare response with antiandrogen therapy (ADT)
If the patient has liver metastases, ALT and AST < 5 x ULN
Subjects must have adequate organ and marrow function as defined below:\n\n               1. hemoglobin ?9.0 g/dL (?5.6 mmol/L)\n\n               2. white blood cells ?3,000/mm³(?3×10?/L)\n\n               3. absolute neutrophil count ?1,500/mm³ (?1.5×10?/L)\n\n               4. platelets ?100,000/?L (?100×10?/L)\n\n               5. total bilirubin ?1.5× upper limit of normal(ULN)\n\n               6. AST/ALT/AP ?2.5× ULN (ALT/AST ?5.0x ULN in case of documented liver metastases\n\n               7. creatinine ?1.5× ULN\n\n               8. albumin ?3.0 g/dL (?30 g/L)\n\n               9. INR ?1.4
Adequate liver function, defined as normal total bilirubin, ALT ?2.0x ULN, and AST ?2.0x ULN measured within 24 hours prior to crenolanib commencement
AST and/or ALT ?5.0 x upper limit of normal (ULN) if liver metastases, or ?3 x ULN without liver metastases
S. Creat. > 1.5 x ULN.
AST/ALT =< 2.5 x ULN if with liver metastases
Hepatic function: Conjugated bilirubin <1.5 × ULN and ALT and AST <3 × ULN
Adequate liver function as assessed by total bilirubin ? 1.5x upper limit of normal (ULN), and alanine transaminase (ALT) and aspartate transaminase (AST) ? 2.5x ULN (? 5.0x ULN in the case of liver metastases). Patients with known Gilbert's syndrome may be enrolled with total bilirubin ? 3.0 mg/dL.
Patients who do not have hepatocellular carcinoma but who have liver lesions or liver metastases may be eligible if they have AST < 3.5 x ULN and AST < 3.5 x ULN if agreed upon by the investigator and medical monitor for the sponsor.
AST/ALT =< 2.5 x ULN and bilirubin =< ULN for patients with liver metastases
total serum bilirubin ?2.5 × ULN or ?5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
Patients must have adequate organ function: a) Bone marrow reserve: ANC ? 1.5 x 109/L, platelets ? 100 x 109/L, hemoglobin ? 9 g/dL b) Cardiac: i) QTcF < 450 msec on at least 2 of 3 screening ECGs. On site determination of QTcF may be used for screening purposes ii) LVEF equal to or greater than the institutional lower limit of normal. LVEF must be evaluated within 7 to 10 days prior to beginning study therapy iii) Cardiac Troponin I within normal limit (as per local institution) c) Hepatic: Total bilirubin ? 1.5 x ULN, ALT, AST ? 3.0 x ULN OR ? 5.0 x ULN for patients with liver metastases d) Renal: Serum/plasma creatinine ? 1.5 x ULN, or for patients with serum/plasma creatinine > 1.5 ULN, creatinine clearance ? 50 mL/min Exclusion Criteria for Part B: The presence of any of the following will exclude the patient from the study:
AST and/or ALT ?5.0 x upper limit of normal (ULN) if liver metastases, or ?3 x ULN without liver metastases
S-creatinine and S-bilirubin ? 1.5 x ULN. S-ALAT and S-ASAT ? 2.5 x ULN (or ?5 in case of liver metastases)
AST/ALT ? 3 x ULN for patients without liver metastasis; ? 5 x ULN for patients with liver metastasis
Bilirubin =< 1.5 x ULN; for subjects with liver metastases =< 3 x ULN is allowed
AST and ALT ? 3 x ULN (? 5 x ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)
Absolute neutrophil count ? 1,000/µL; platelets ? 75,000/µL; creatinine ? 1.5x upper limit of normal (ULN); total bilirubin ? 1.5x ULN; AST/ALT ? 2.5x ULN. For subjects with documented liver metastases, the AST/ALT may be ? 5x ULN.
Liver Transaminases (ALT/AST) ? 2.5 x ULN, ? 5.0 x ULN if liver metastases present
Required Initial Laboratory Values: Leukocytes ?2000/ µl Hemoglobin >9.0 g/dL Platelets ?100,000/ µl ANC ?1,500/mcL Serum creatinine ? 1.5 x ULN or creatinine clearance (CrCl) ? 40 mL/min (if using the Cockcroft-Gault formula below): Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 Total Bilirubin <1.5 mg/dl (except for subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dl) SGOT (AST) <2.5 x ULN ALP <2.5 x ULN in absence of liver metastases (<5 x ULN if liver metastases present PTT <1.5 x ULN
Serum transaminases activity =< 2.5 x ULN, with the exception of serum transaminases (< 3 x ULN) if the patient has liver metastases
B-type Natriuretic Peptide (BNP) above 3 times the baseline value and above the ULN that is sustained consecutive, scheduled blood draws. Troponin I above ULN, high sensitive C-reactive protein (hsCRP) above ULN or Cystatin above ULN.
Chronic liver disease (bilirubin > 1.5 x ULN, ALT or AST > 2 x ULN)
Adequate liver function: Alanine transaminase (ALT) < 2 x Upper Limit of Normal (ULN) and bilirubin < 1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). If liver metastases are present ALT must be < 5 x ULN
Transaminases < 3 x ULN
Total bilirubin >1.5 x ULN if no liver metastases or >3 x ULN in the presence of liver metastases (except in the case of Gilbert's disease)
Hepatic and renal function meeting the strata below:\r\n* Group N: Hepatic: normal function (bilirubin =< ULN; AST =< ULN); renal: normal function (creatinine clearance [CrCl] >= 60 mL/min as estimated by the Cockcroft and Gault equation)\r\n* Group R3: Hepatic: normal function (bilirubin =< ULN; AST =< ULN); renal: severe dysfunction (CrCl >= 15 and < 30 mL/min as estimated by the Cockcroft and Gault equation)\r\n* Group R4: Hepatic: normal function (bilirubin =< ULN; AST =< ULN; renal: renal failure (hemodialysis)\r\n* Group H1: Hepatic: mild dysfunction (bilirubin =< ULN; AST > ULN); renal: acceptable function (CrCl >= 60 mL/min as estimated by the Cockcroft and Gault equation)\r\n* Group H2: Hepatic: moderate dysfunction (bilirubin > ULN and =< 3 x ULN; AST > ULN); renal: acceptable function (CrCl>=? 60 mL/min as estimated by the Cockcroft and Gault equation)\r\n* Group H3: Hepatic: severe dysfunction (bilirubin > 3 x ULN and up to investigators discretion; AST > ULN); renal: acceptable function (CrCl >= 60 mL/min as estimated by the Cockcroft and Gault equation)
Bilirubin < 2 x ULN (or < 5 x ULN if liver is involved)
Adequate liver function, as evidenced by a serum bilirubin </=2x the ULN (except for patients with a confirmed diagnosis of Gilbert's Disease) and an ALT or AST </=3x the laboratory ULN.
Adequate liver function, defined as bilirubin ?1.5x ULN, ALT ?3.0x ULN, and AST ?3.0x ULN
Adequate liver functions: AST and ALT =< 3xULN, alkaline phosphatase =< 3.0x ULN, except if attributed to tumor, and bilirubin =< 2xULN.
For subjects with liver metastases: ALT and AST =< 5 x ULN
Adequate liver function Total Serum Bilirubin <=1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) <=2.5ULN (if liver metastases are present, then <=5ULN is allowed) ALP <=2.5ULN (if liver and/or bone metastases are present, then <=5ULN is allowed)
AST and ALT ? 3 ULN (? 5 x ULN for subjects with liver metastases)
Adequate hepatic function, defined as total bilirubin ?1.5 × upper limit of normal (ULN); AST ?2.5 × ULN; and ALT ?2.5 × ULN. For subjects with documented metastatic disease to the liver, AST and ALT: ?5 × ULN.
Adequate hepatic function, defined as total bilirubin ?1.5 × ULN; AST ?2.5 × ULN; and ALT ?2.5 × ULN.
Adequate liver function Total Serum Bilirubin <=1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) <=2.5ULN (if liver metastases are present, then <=5ULN is allowed) ALP <=2.5ULN (if liver and/or bone metastases are present, then <=5ULN is allowed)
1.5 x ULN
Adequate bone marrow, liver & renal function as assessed by the following laboratory requirements to be conducted w/in 7 days prior to start of first dose: Hemoglobin >/= 9.0 g/dL; Absolute neutrophil count (ANC) >/= 1,500/mm^3; Platelet count >/= 100,000/mm^3; Total bilirubin </= 1.5 times the upper limit of normal (ULN);ALT and AST </= 2.5 x ULN (</= 5 x ULN for pts w/ liver involvement); INR </= 1.5 and PTT w/in normal limits
AST and ALT ? 3.0 x ULN or ? 5 x ULN if subject has documented liver metastases
Adequate hepatic function (total bilirubin ? 1.5x ULN; AST and ALT ? 3x ULN).
Aspartate aminotransferase ?3 × ULN for the reference lab (?5 × ULN for subjects with known hepatic metastases)
ALT and AST ? 2.5 upper limit normal (ULN), or < 5 x ULN if liver metastases are present; serum total bilirubin ? ULN or 1.5 x ULN if liver metastases are present or total 3 x ULN with direct bilirubin ? ULN in patients with well documented Gilbert Syndrome.
Adequate hepatic function: AST and ALT <2.5 x ULN, Total and Direct Bilirubin <1.5 x ULN. However, in the presence of liver metastases, AST and ALT must be <5 x ULN
Hepatic function: total bilirubin ? 1.5 x ULN; ALT and AST ? 3 x ULN; alkaline phosphatase ? 2.5 x ULN
Transaminases =< 2 x ULN, except in known hepatic disease, wherein may be =< 5 x ULN
Transaminases =< 2 x ULN
AST and ALT ?2.5 x ULN for subjects without liver metastases and ?3.5 x ULN for subjects with liver metastases
Adequate hepatic function as evidenced by: serum total bilirubin ?1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease, a gene mutation in UGT1A1, or disease involvement, following approval by the Medical Monitor; AST, ALT, ALP ?2.5 × ULN, with the exception of subjects with bone metastases and/or suspected disease-related liver or biliary involvement, where ALP must be ?5 × ULN
Total bilirubin ? 1.5 × institutional ULN [? 2.0 x ULN in presence of liver metastases] within 14 days prior to randomization.
- Hepatic function: aspartate aminotransferase (AST)/ Alanine Amino Transferase (ALT) = 1.5 X Upper Limit of Normal (ULN) and bilirubin = ULN for patients without liver metastases. AST/ALT = 2.5 X ULN and bilirubin = ULN for patients with liver metastases. Patients with Gilbert syndrome and bilirubin < 2 X ULN and normal AST/ALT are eligible
Adequate hepatic function: serum total bilirubin ? 2X greater than the upper limit of normal (ULN) (? 3X ULN in subjects with liver metastases), aspartate aminotransferase) AST) / alanine aminotransferase (AST) ? 2X the ULN for the local reference lab (? 5X the ULN for subjects with liver metastases)
Has adequate hepatic function, defined as: AST/ALT <= 3 X ULN (if liver metastases are present, <= 5 X ULN) Bilirubin <= 1.5 X ULN
Hepatic: total bilirubin ? 1.5 X ULN, ALT and AST ? ULN;
Adequate hepatic function including ALT ? 2.5 x upper limit of normal (ULN) if liver metastasis is NOT present or ? 5 x ULN if liver metastasis is present, and total bilirubin ? 1.5 x ULN.
Adequate liver function defined as: bilirubin (sum of conjugated + unconjugated) <=1.5 x upper limit of normal (ULN) for age, aspartate aminotransaminase (AST) and alanine transaminase (ALT) <=2.5 x ULN; AST/ALT may be <5 x ULN at baseline if disease under treatment involves the liver (requires radiographic confirmation of liver involvement).
ALT or AST < 2.5 X ULN in the absence of liver metastases
Adequate hepatic function, defined as AST and ALT ?3.0X ULN and serum direct bilirubin ?1.5X ULN. Exceptions may be made for patients with elevated liver transaminases secondary to AML after discussion with the Medical Monitor
Adequate laboratory values. a) Hemoglobin >/=10 gm/dL. b) White blood cell count (WBC) >/= 3000/µL. c) Absolute neutrophil count (ANC) >/= 1500/µL. d) Platelet count >/=100,000/µL. e) PT </= 1.5 x upper limit of normal (ULN). f) Activated partial thromboplastin time (aPTT) </= 1.5 x ULN. g) AST </=1.5 x ULN. h) ALT </= 1.5 x ULN. i) Total bilirubin </= 1.5 x ULN. j) Creatinine </=1.5 x ULN.
Liver Function If bilirubin, AST, and/or ALT are >ULN
Patients with underlying liver disease, such as cirrhosis or chronic hepatitis, and do not have primary or metastatic cancer in the liver will be excluded if alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN) or total bilirubin (bili) > 3 x ULN; in the presence of primary or metastatic liver cancer, patients will be excluded if ALT/AST > 5 x ULN or total bili > 5 x ULN
Abnormal liver function (total bilirubin > 2X ULN or liver enzymes alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 2.5X ULN for subjects without liver metastasis or ? 5X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening. Subjects with documented Gilbert's Disease may be eligible.
Patients with abnormal liver function will be eligible and will be grouped according to the criteria below\r\n* Group A (normal hepatic function)\r\n** Bilirubin =< upper limit of normal (ULN) and aspartate aminotransferase (AST) =< ULN\r\n* Group B (mild hepatic dysfunction)\r\n** B1: bilirubin =< ULN and AST > ULN\r\n** B2: bilirubin > ULN but =< 1.5 x ULN and any AST\r\n* Group C (moderate hepatic dysfunction)\r\n** Bilirubin > 1.5 x ULN to =< 3 x ULN and any AST\r\n* Group D (severe hepatic dysfunction) \r\n** Bilirubin > 3 x ULN and up to investigators discretion and any AST\r\n* Patients with active hemolysis should be excluded; no distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes; registration laboratory investigations will be used to assign a patient to a hepatic function group; liver function tests should be repeated within 24 hours prior to starting initial therapy and may result in the patients' group assignment being altered if different to registration test results
- AST and ALT < 2.5 x ULN (< 5 x ULN in patients with known liver metastases)
ALT/AST ? 2.5 x ULN or ? 5 x ULN if documented liver metastases
Aspartate aminotransaminase (AST) =< 2.5 x upper limit of normal (ULN) (=< 5.0 x in case of liver [metastases] mets), within 2 weeks prior to study start
- AST and ALT < 2.5 x ULN (< 5 x ULN in patients with known liver metastases)
Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
AST and ALT ? 3.0 x ULN, independently of the presence of liver metastases.
AP ? 2.5 x ULN (? 5 x ULN if disease-related).
Cohort 1 (normal hepatic function): Bilirubin ? ULN; AST ? ULN
Creatinine =< 1.5 times ULN
Total bilirubin equal to or less than 1.5 times the ULN
Creatinine less than 1.5 times the ULN
Aspartate aminotransferase (AST) > 2.5 times ULN if no demonstrable liver metastases, or > 5 times ULN in presence of liver metastases
PT ? 1.5 times institutional ULN
PTT ? 1.5 times institutional ULN
Serum creatinine =< 2 times ULN; timeline: within 3 weeks prior to enrollment
Within 30 days prior to enrollment: Total bilirubin equal to or less than 1.5 times the ULN
Within 30 days prior to enrollment: Creatinine less than 1.5 times the ULN
Total serum bilirubin ?1.5 times ULN
Total bilirubin < 1.5 times the upper limit of normal (ULN) if no liver metastases or < 3 times the ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or liver metastases
Total bilirubin < 1.5 times the upper limit of normal (ULN) if no liver metastases or < 3 times the ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or liver metastases
Total serum bilirubin > 1.5 times ULN
Bilirubin =< 1.5 times ULN before starting therapy
Aspartate aminotransferase > 2.5 times the ULN if no demonstrable liver metastases or > 5 times the ULN in the presence of liver metastases.
Total bilirubin > 1.5 times the ULN if no liver metastases or > 3 times the ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases.
Total bilirubin >1.5 times ULN
Creatinine < 1.5 times ULN.
Has liver fibrosis either determined by imaging or laboratory testing (i.e. total serum bilirubin > 1.5 times ULN, AST and ALT > 2.5 times ULN, INR > 1.5 times ULN, albumin < 2.5 mg/dl)
Total bilirubin < 1.5 times ULN if no liver metastases or < 3 times ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinaemia) or liver metastases obtained =< 14 days prior to study initiation
Total bilirubin >1.5 times ULN if no liver metastases or 3 times ULN in the presence of liver metastases or documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia)
Total bilirubin > 1.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 3 times ULN in the presence of documented Gilbert’s syndrome or liver metastases
Total serum bilirubin ? 1.5 times the ULN
Bilirubin =< 1.5 ULN (for patients with liver metastasis up to =< 5 times of ULN is allowed)
Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) (or =< 3 times ULN in case of liver metastasis or Gilbert syndrome)
Total bilirubin </=2 times the ULN
Creatinine =< 1.5 times ULN
Creatinine < 1.5 times ULN
Aspartate aminotransferase (AST) >2.5 times ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases
Creatinine =< 1.5 times ULN
Total bilirubin ?1.5 times ULN; and
Total bilirubin ?1.5 times ULN; and
Aspartate aminotransferase > 2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases
Total bilirubin > 1.5 times ULN if no liver metastases or > 3 times ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or liver metastases
ALT/AST ? 2.5 times ULN, or < 5 times ULN for subjects with liver metastases
Within 14 days of first dose of study drug administration: Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) (or =< 3 times ULN in case of liver metastasis)
ALT/AST ? 2.5 times ULN, or < 5 times ULN for subjects with liver metastases
EXCLUSION CRITERIA FOR ENROLLMENT: Total bilirubin > 3 times the ULN
Failure to meet the following laboratory levels on preoperative screening:\r\n* Platelet count >= 100,000 mm^3\r\n* Hemoglobin >= 10 g/dl\r\n* Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)\r\n* Activated partial thromboplastin time =< 1.5 times ULN\r\n* Serum creatinine < 2.5 times ULN
Serum bilirubin < 1.5 times ULN
total bilirubin 1.5 times greater than the ULN, except if related to ALL/LBL,
Creatinine and total bilirubin ? 1.5 times ULN
Creatinine =< 1.5 times ULN
Bilirubin =< 1.5 times ULN
Bilirubin < 2 times ULN (performed within 14 days prior to registration)
Alanine aminotransferase > 2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases; aspartate aminotransferase > 2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases
Total bilirubin > 1.5 times ULN if no liver metastases or > 3 times ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or liver metastases
AST and ALT < 5 times ULN; ALP < 5 times ULN; Bilirubin ? 1.5 times ULN; Creatinine ? 1.5 times ULN and eGFR ? 50.
ALT and AST >3.0 times the ULN if no liver involvement or >5 times the ULN with liver involvement.
Serum bilirubin < 1.5 times the upper limit of normal (ULN); unless due to Gilbert’s syndrome (in which < 2 times ULN acceptable)
Bilirubin > 1.5 times ULN
Total bilirubin <1.5 times ULN
ALT/AST ? 2.5 times ULN, or < 5 times ULN for subjects with liver metastases
Serum direct bilirubin (DB) =< 1.5 times ULN within 14 days prior to admission
Creatinine =< 1.5 times ULN
ALT/AST less than or equal to 3 times ULN or less than or equal to 5 times ULN in the setting of liver metastases.
Total bilirubin less =< to 1 times ULN
Total serum/plasma bilirubin ?1.5 times ULN.
Total bilirubin < 1.5 times ULN
Liver transaminases within 2.5 times ULN
Bilirubin < 1.5 times ULN, unless bilirubin elevation is related to Gilbert’s syndrome for which bilirubin must be < 4 times ULN
Alkaline phosphatase ? 2.5 times ULN (? 5 times ULN for patients with liver metastases);
Total bilirubin >= 1.5 times ULN
Total bilirubin =< 1.5 times ULN*
Serum bilirubin levels =< 1.5 times the ULN range for the laboratory
Bilirubin no greater than 1.5 times ULN
Bilirubin < 2 times ULN
Total bilirubin =< 2.5 times ULN
Total bilirubin should be < 1.5 times ULN
Ammonia < 1.5 times ULN
SGOT < 2.5 times ULN
Bilirubin =< 1.5 times ULN
Total bilirubin =< 1.5 times ULN and stable X 1 month
Serum bilirubin =< 2 times ULN
Inadequate hepatic function (Total bilirubin > 1.5 times the institutional upper limit of normal (ULN) (except known Gilbert's syndrome); Alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5 times the institutional ULN. ALT or AST up to 3 times the institutional ULN permitted if total bilirubin is normal
Carcinoembryonic antigen (CEA)</=3 times the ULN
PT or aPTT < 1.5 times the ULN
Creatinine >= 1.5 times ULN
Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), ALT, and aspartate transferase (AST) less than or equal to 2.0 times ULN. If the liver has tumor involvement AST and ALT equaling less than or equal to 5 times ULN are acceptable.
ALT < 3 times ULN and bilirubin < 1.5 mg/dL
Serum ALT < 2.5 times the ULN.
Bilirubin < 1.5 times ULN
Total bilirubin < 1.5 times ULN
Urea and serum creatinine < 2.5 times ULN
Total bilirubin < 1.5 times ULN
AST ? 2.5 times ULN (? 5 times ULN for patients with liver metastases);
Alkaline phosphatase ? 2.5 times ULN (? 5 times ULN for patients with liver metastases);
Obtained within 14 days prior to initiation of treatment: Serum creatinine =< 1.5 times ULN
Bilirubin ? 2.0 mg/dl; AST and ALT < 5.0 times the ULN
DONOR: Total creatinine kinase > 2 times the ULN
Total bilirubin level greater than 3 times the ULN
Aspartate aminotransferases (AST) =< 3 times ULN
DONOR: Total creatinine kinase > 2 times the ULN
Has laboratory results that are outside of normal limits at screening, as follows: a) Moderate or severe liver dysfunction, as defined as: Aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN), OR Alanine aminotransferase (ALT) > 5 times the ULN, OR Serum total bilirubin >2.5 times the ULN, OR AST or ALT > 3 times ULN with total bilirubin > 2 times ULN; b) Calculated creatinine clearance <30 mL/min.
Serum creatinine within 1.5 times the institution’s ULN
Bilirubin < 2 times ULN, performed within 28 days prior to registration
Total serum/plasma bilirubin ?1.5 times ULN.