AST < . x ULN (. x ULN in the presence of liver metastasis)
ALT < . x ULN (. x ULN in the presence of liver metastasis).
AST and ALT must be less than or equal to . 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 x ULN.
ALP, ALT, and AST > x ULN (> x ULN if subject has liver metastases)
Has adequate hepatic function, defined as: AST/ALT levels =< x ULN (if liver metastases are present, =< x ULN) Bilirubin =< . x ULN.
AST ?. x ULN (if liver or bone mets are present, ? x ULN)
ALT ?. x ULN (if liver or bone metastases are present, ? x ULN)
Aspartate transaminase (AST) =< x ULN, except for patients with liver metastasis, who are included if AST =< x ULN, at the screening visit
Alanine transaminase (ALT) =< x ULN, except for patients with liver metastasis, who are only included if ALT =< x ULN, at the screening visit
For subjects with liver metastasis, adequate liver function is demonstrated by AST/ALT =< . x ULN
AST and/or ALT ?. ULN, < ULN w/liver metastases
Liver Transaminases (ALT/AST) ? . x ULN, ? . x ULN if liver metastases present
AST (aspartate aminotransferase) =< x ULN\r\n* NOTE: ALT and/or AST may be =< x ULN if due to liver metastases. If ALT or AST is > and =< x ULN in patients with liver metastases
ALT and AST ? x ULN or ? x ULN if documented liver infiltration with leukemia cells
ALT or AST > . ULN in patients (pts) without liver metastasis
For pts with liver metastasis: ALT or AST > . ULN
Aspartate aminotransaminase (AST), alanine aminotransaminase (ALT) within . x institutional upper limits of normal unless there are liver metastases in which case AST and ALT within . x ULN
If liver metastasis present, then AST/ALT =< x ULN
CERITINIB INCLUSION CRITERIA: AST (SGOT) and ALT (SGPT) =< x ULN if no liver metastases are present? =< x ULN if liver metastases are present
REGORAFENIB INCLUSION CRITERIA: AST (SGOT) and ALT (SGPT) =< . x ULN if no liver metastases are present? =< x ULN if liver metastases are present
ENTRECTINIB INCLUSION CRITERIA: AST (SGOT) and ALT (SGPT) =< . x ULN if no liver metastases are present? =< x ULN if liver metastases are present
Aspartate transaminase (AST) < . x ULN, except for patients with liver metastasis, who are only included if AST < x ULN; alanine transaminase (ALT) < . x ULN, except for patients with liver metastasis, who are only included if ALT < x ULN
AST and ALT ? x ULN for age unless elevation can be clearly attributed to liver leukemia or metastases
ARM B COHORT : AST and ALT =< X ULN; if liver metastases are present then must be < X the ULN
ARM B COHORT : AST and ALT =< X ULN; if liver metastases are present then must be < X the ULN
For subjects with liver metastasis, adequate liver function is demonstrated by serum bilirubin =< x ULN and AST/ALT =< . x ULN
AST and ALT ? x ULN or ? x ULN for subjects with known liver metastases
Aspartate transaminase (AST) =< . x ULN, except for patients with liver metastasis, who are only included if AST =< x ULN; alanine transaminase (ALT) < . x ULN, except for patients with liver metastasis, who are only included if ALT < x ULN
AST/ALT > .-fold above ULN (>-fold above ULN if liver metastases)
For Phase I and II: Adequate liver (bilirubin </=x ULN, ALT </=.x ULN) and renal (creatinine </=x ULN) function. For patients with suspected liver infiltration from leukemia ALT should be </= ULN.
Exception for patients with liver metastasis: total bilirubin =< x ULN; ALT (SGPT) =< X ULN
Obtained =< days prior to randomization:\r\nAspartate transaminase (AST) =< . x ULN (or =< x ULN in presence of liver metastases)
AST and ALT must be less than or equal to . 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 x ULN.
DOSE ESCALATION COHORT: \r\n* Note: Subjects with bone metastasis and no liver metastasis on screening image may enroll if ALP is < X ULN; subjects with liver metastasis may enroll if all of AST/ALT/ALP are < X ULN; however, subjects with extensive liver metastasis occupying more than % of liver parenchyma will be excluded per epacadostat investigators brochure
DOSE EXPANSION COHORT: \r\n* Note: subjects with bone metastasis and no liver metastasis on screening image may enroll if ALP is < X ULN; subjects with liver metastasis may enroll if all of AST/ALT/ALP are < X ULN; however, subjects with extensive liver metastasis occupying more than % of liver parenchyma will be excluded per epacadostat investigators brochure
If the patient has liver metastases, ALT and AST < x ULN
AST and/or ALT ?. x upper limit of normal (ULN) if liver metastases, or ? x ULN without liver metastases
AST/ALT =< . x ULN if with liver metastases
Patients who do not have hepatocellular carcinoma but who have liver lesions or liver metastases may be eligible if they have AST < . x ULN and AST < . x ULN if agreed upon by the investigator and medical monitor for the sponsor.
AST/ALT =< . x ULN and bilirubin =< ULN for patients with liver metastases
Alanine aminotransferase (ALT) =< . x ULN for patients without liver metastases; for patients with liver metastasis ALT =< x ULN is allowed
AST and/or ALT ?. x upper limit of normal (ULN) if liver metastases, or ? x ULN without liver metastases
S-creatinine and S-bilirubin ? . x ULN. S-ALAT and S-ASAT ? . x ULN (or ? in case of liver metastases)
Patients with liver metastasis may not be included if AST and/or ALT > xULN
AST/ALT ? x ULN for patients without liver metastasis; ? x ULN for patients with liver metastasis
Bilirubin =< . x ULN; for subjects with liver metastases =< x ULN is allowed
AST and ALT ? x ULN (? 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 days)
Absolute neutrophil count ? ,/L; platelets ? ,/L; creatinine ? .x upper limit of normal (ULN); total bilirubin ? .x ULN; AST/ALT ? .x ULN. For subjects with documented liver metastases, the AST/ALT may be ? x ULN.
AST/ALT ? X ULN [with underlying Liver Metastasis]
AST and ALT =< . x ULN (=< x ULN if liver metastases are present) obtained =< days prior to registration
Liver Transaminases (ALT/AST) ? . x ULN, ? . x ULN if liver metastases present
ALT or AST > . ULN in patients (pts) without liver metastasis; for pts with liver metastasis: ALT or AST > x ULN
Chronic liver disease (bilirubin > . x ULN, ALT or AST > x ULN)
AST/ALT levels ? . x ULN, or ? x ULN if liver metastases are present.
Alanine aminotransferase (ALT) =< . x ULN for patients without liver metastases; for patients with liver metastasis ALT =< x ULN is allowed
AST level ?. x ULN and ALT ? . ULN. For patients with liver metastases, AST ?. x ULN, and AST ?. x ULN may be enrolled if agreed upon by the investigator and medical monitor for the sponsor.
Adequate liver function, defined as bilirubin ?.x ULN, ALT ?.x ULN, and AST ?.x ULN
ALT =< . x =< x ULN if liver metastases persist
For subjects with liver metastases: ALT and AST =< x ULN
Adequate liver function Total Serum Bilirubin <=. x upper limit of normal (ULN) Transaminases (AST/ALT) <=.ULN (if liver metastases are present, then <=ULN is allowed) ALP <=.ULN (if liver and/or bone metastases are present, then <=ULN is allowed)
Exception for patients with liver metastasis: ALT (SGPT) =< x ULN
AST and ALT ? ULN (? x ULN for subjects with liver metastases)
Adequate liver function Total Serum Bilirubin <=. x upper limit of normal (ULN) Transaminases (AST/ALT) <=.ULN (if liver metastases are present, then <=ULN is allowed) ALP <=.ULN (if liver and/or bone metastases are present, then <=ULN is allowed)
AST and ALT ? . x ULN or ? x ULN if subject has documented liver metastases
For patients with tumor involvement of the liver AST or ALT > x ULN
ALT and AST ? . upper limit normal (ULN), or < x ULN if liver metastases are present; serum total bilirubin ? ULN or . x ULN if liver metastases are present or total x ULN with direct bilirubin ? ULN in patients with well documented Gilbert Syndrome.
Adequate hepatic function: AST and ALT <. x ULN, Total and Direct Bilirubin <. x ULN. However, in the presence of liver metastases, AST and ALT must be < x ULN
AST and ALT ?. x ULN for subjects without liver metastases and ?. x ULN for subjects with liver metastases
- Hepatic function: aspartate aminotransferase (AST)/ Alanine Amino Transferase (ALT) = . X Upper Limit of Normal (ULN) and bilirubin = ULN for patients without liver metastases. AST/ALT = . X ULN and bilirubin = ULN for patients with liver metastases. Patients with Gilbert syndrome and bilirubin < X ULN and normal AST/ALT are eligible
Has adequate hepatic function, defined as: AST/ALT <= X ULN (if liver metastases are present, <= X ULN) Bilirubin <= . X ULN
Adequate hepatic function including ALT ? . x upper limit of normal (ULN) if liver metastasis is NOT present or ? x ULN if liver metastasis is present, and total bilirubin ? . x ULN.
Adequate liver function defined as: bilirubin (sum of conjugated + unconjugated) <=. x upper limit of normal (ULN) for age, aspartate aminotransaminase (AST) and alanine transaminase (ALT) <=. x ULN; AST/ALT may be < x ULN at baseline if disease under treatment involves the liver (requires radiographic confirmation of liver involvement).
ALT or AST < . X ULN in the absence of liver metastases
Liver Function If bilirubin, AST, and/or ALT are >ULN
Aspartate transaminase (AST) > . x ULN, except for patients with liver metastasis who are excluded if AST > . x ULN
Alanine transaminase (ALT) > . x ULN, except for patients with liver metastasis who are excluded if ALT > . x ULN
Abnormal liver function (total bilirubin > X ULN or liver enzymes alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > .X ULN for subjects without liver metastasis or ? X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening. Subjects with documented Gilbert's Disease may be eligible.
- AST and ALT < . x ULN (< x ULN in patients with known liver metastases)
AST and ALT =< . X ULN or =< x ULN if liver metastases are present (evaluated within days of randomization); concomitant elevations in bilirubin and AST/ALT above . x ULN are not permitted
ALT/AST ? . x ULN or ? x ULN if documented liver metastases
- AST and ALT < . x ULN (< x ULN in patients with known liver metastases)
Alanine transaminase (ALT) =< x ULN (=< x ULN acceptable for pancreatic subjects with known liver metastasis only)
AST and ALT ? . x ULN, independently of the presence of liver metastases.