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