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