Bilirubin =< 1.5 x normal
Patients with bilirubin =< 2 x upper limit of normal
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Bilirubin =< 1.5 X the upper limit of normal
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Bilirubin =< 1.5 X the upper limit of normal
Bilirubin =< 1.5 x laboratory normal
Bilirubin =< 1.5 x upper limit of normal range
TREATMENT: Bilirubin =< 2 x upper limit of normal
Patients with bilirubin =< 3 x normal
Bilirubin < 1.5 mg/dL, ALT < 3 x upper limit of normal
Patients with bilirubin ? 2 x upper limit of normal
Liver function: total bilirubin < 2x the upper limit of normal and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5x the upper normal limit (Patients with Gilbert's Disease are permitted to exceed the defined bilirubin value of 2x the upper limit of normal, however measurements of direct bilirubin should be done to confirm this diagnosis).
INCLUSION - INFUSION: Patients with bilirubin ? 3 x upper limit of normal
Bilirubin > 1.5 x the upper limit of normal
Bilirubin ? 2X upper limit of normal
Bilirubin ? 2 x upper limit of normal
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Patients with bilirubin ? 3 x upper limit of normal
Patients with bilirubin ? 2x upper limit of normal
Bilirubin ? 1.5 x upper limit of normal
Total bilirubin < 1.5 x upper limit of reference range (< 3 x upper limit of reference range in patients with Gilbert's disease)
Baseline serum troponin above the upper limit of normal
Patients with 5-­hydroxyindoleacetic acid (HIAA) levels above or below the upper limit of normal range (normal: 0 to 15 mg/24 hours) and those with unknown values at baseline are allowed to participate
Bilirubin < 1.5 x upper limit of normal
Bilirubin level above the normal reference range
Serum conjugated (direct) bilirubin < 2 x upper limit of normal for age as per local laboratory
Cardiac troponin value above the Upper Limit of Normal (ULN);
Total bilirubin ? 1.5 X the upper normal limit of institution's normal range
PT and PTT must be ? 1.5 X upper normal limit of institution's normal range
Total bilirubin =< 1.5 x the upper normal limit of institution's normal range, at the time of enrollment; for subjects with liver metastases, total bilirubin > 1.5 - 3.0 x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
Must have had an elevated serum CA125 level twice the upper limit of normal (per reference lab normal range) measured within 4 weeks of enrollment.
Bilirubin =< to 2.0 x normal.
Within 4 weeks prior to the registration: bilirubin =< 1.5 X upper limit of normal
Total bilirubin =< 1.5 x the upper normal limit of institution's normal range; for subjects with liver metastases, total bilirubin > 1.5 - 3.0 x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
Serum bilirubin < 1.5 x upper limit of normal values
Total bilirubin =< 1.5 x upper limit of reference range ( < 3 x upper limit of reference range in patients with Gilbert’s disease)
Documented bilirubin and hepatic transaminases of =< 2.5 x upper limit of normal (ULN)
AT THE TIME OF INFUSION: Bilirubin ? 3 x normal
TREATMENT: Patients with bilirubin ? 2 x upper limit of normal
PART 2: Transaminases must be < 3 x the upper limit of normal
Patients must have bilirubin < 1.5 x normal
Serum bilirubin =< twice the upper limit of normal
Transaminases > 5x upper limit of normal for age
Conjugated (direct) bilirubin less than 2 x upper limit of normal
Bilirubin =< 1.5 x the upper limit of normal
Bilirubin =< 2x upper limit of normal
Bilirubin less than or equal to 2 x upper limit of normal
Bilirubin =< 3 x upper limit of normal
Bilirubin =< 1.5 fold the upper limit of normal
Bilirubin =< 2.5 X the upper normal limit of institution's normal range
Bilirubin =< 1.5 x normal
Direct bilirubin > 3x upper limit of normal
Bilirubin =< 3 x upper limit of normal
Bilirubin < 5 x upper limit of normal
Bilirubin < 5 x normal
Liver: transaminases < 5 x upper limit of normal and bilirubin < 3 x upper limit of normal
Bilirubin < 1.5 x upper limit of normal
Bilirubin level above the normal reference range
Bilirubin =< to 2.0 x normal
Bilirubin < 2 x the upper limit of normal (except patients with Gilbert Syndrome in whom bilirubin level of > 2 x upper normal limit will be allowed)
Transaminases must be < 3 x the upper limit of normal per reference values of treating institution
Non-fasting bilirubin =< 1.5 X the upper normal limit of institution's normal range
Bilirubin =< 1.5 x upper limit of normal
Patients must have serum direct bilirubin =< 2.0 mg/dl and transaminases =< 3x institution upper limit of normal
Transaminases < 2.5 x upper limit of normal
Non-fasting direct bilirubin =< 1.5 × the upper normal limit of institution's normal range
Transaminases < 5.0 x upper limit of normal (ULN)
Total bilirubin =< upper limit of normal (or =< 1.5 x upper limit of normal if live metastases are present; or total bilirubin =< 3.0 x upper limit of normal with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome, which is defined as presence of several episodes of unconjugated hyperbilirubinemia with normal results from complete blood count [CBC] count [including normal reticulocyte count and blood smear], normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)
Bilirubin < 1.5 x ULN of the institutional normal reference range
Bilirubin =< 2 x upper limit of normal value
Transaminases < 2.5 x upper limit of normal (up to 5 x upper limit of normal [ULN] in patients with liver metastases)
Bilirubin =< 3 x upper limit of normal
Bilirubin =< 1.5 X laboratory normal
Bilirubin* within normal range
Transaminases < 3x upper limit of normal
Total bilirubin > 1.5 x the upper limit of reference range (ULRR)
Serum bilirubin < 2 x upper limit of normal, or considered not clinically significant by the study doctor or designee
Bilirubin < 2 x the upper limit of normal
Bilirubin =< 1.5 x upper limit of normal
AT THE TIME OF INFUSION: Bilirubin ? 3 x upper limit of normal
Transaminases must be < 3 x the upper limit of normal per reference values of referring institution
Patients who test positive for hepatitis C antibody (Ab) are eligible provided all of the following criteria are met: 1) total bilirubin =< 2 x upper limit of normal; 2) AND aspartate aminotransferase (AST) =< 3 x upper limit of normal; AND 3) liver biopsy (pathology) demonstrates =< grade 2 fibrosis and no cirrhosis
Non-fasting direct bilirubin =< 1.5 × the upper normal limit of institution's normal range; for subjects with liver metastases, non-fasting direct bilirubin > 1.5-3.0 x the upper normal limit of institution's normal range are acceptable AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia; the combination of 5-FU and oxaliplatin is known to be safe to be administered in patients with such abnormal liver function tests
Within 14 days prior to registration: Bilirubin =< 1.5 x upper limit of normal range
Transaminases =< 5 x the upper limit of normal for age appropriate indices
Patients with bilirubin =< 2 x upper limit of normal
Bilirubin =< 1.5 x normal
Bilirubin less than or equal to 1.5 x upper limit of normal, CTCAE v 4.0 grade 1
Bilirubin =< 1.5 x upper limit of normal
Sodium >= 130 mg/dl and =< upper limit of normal
Bilirubin >= 3 x upper limit of normal
Bilirubin < 5 x upper limit of normal
Non-fasting bilirubin =< 1.5 X the upper normal limit of institution's normal range; non-fasting bilirubin 1.5 - 3.0 X the upper normal limit of institution's normal range are acceptable AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
Bilirubin =< to 2.0 x normal
Conjugated bilirubin less than twice the upper limit of normal
Bilirubin =< 1.5 x upper limit normal
Bilirubin: ? 1.5 × the upper normal limit of institution's normal range.
Bilirubin < 2.0 mg/mL x upper limit of normal; this requirement reflects the excretion of CPX-351 by the liver
Bilirubin =< 1.5 x normal
Bilirubin ? 1.5 X upper limit of normal
Direct bilirubin 5 x upper limit of normal (based on institutional standards)
Bilirubin less than 1.5 x normal limit (NL)
Bilirubin > 5 x upper limit of normal if documented in the last month and not lowered to < 5 x normal prior to study enrollment; extra blood work will not be drawn unless the patient already has the lab abnormalities documented and need to be corrected
Serum bilirubin > 1.5 x the upper limit of reference range (ULRR)
Bilirubin\t< 1.5 x normal
Bilirubin =< 2 x upper limit normal
Bilirubin < 5 x upper limit of normal
Bilirubin =< 3 x upper limit of normal
Bilirubin > 1.5 × upper limit of normal (CTCAE grade 2)
Bilirubin =< 3 x normal
Serum bilirubin > 1.5 x the upper limit of reference range (ULRR)
Liver function: total bilirubin < 1.5 x the upper limit of normal and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5x the upper normal limit. Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.
Individuals with bilirubin > 2.5 x normal upper limit any time during the previous 2 months
Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109/l), adequate renal function (serum creatinine ? 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ? 2.5 x upper limit of normal, alkaline phosphatase ? 2.5 x upper limit of normal and total bilirubin ? 2.0 x upper limit of normal).
Bilirubin =< 1.5 x normal
bilirubin <2x upper limit of normal for age