Direct or total bilirubin < 1.5 x ULN (unless related to Gilbert’s or Meulengracht’s syndrome); the values must be obtained within 48 hours prior to randomization
Total bilirubin =< 1.5 x ULN; except subjects with known Gilbert’s syndrome
Total serum bilirubin =< 1.5 X ULN (except participants with Gilbert’s syndrome, who can have a total bilirubin [bili] < 5 X ULN), performed within 14 days of treatment initiation
Total bilirubin ? 1 X ULN (subjects with Gilbert’s disease can have bilirubin of up to 1.5 X ULN)
Total bilirubin: =< 1.5 x ULN (in case of known Gilbert’s syndrome, < 2 x ULN is allowed) within 8 weeks of pre-registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Total bilirubin: =< 1.5 x ULN (in case of known Gilbert’s syndrome, < 2 x ULN is allowed) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): Total bilirubin: =< 1.5 x ULN (in case of known Gilbert’s syndrome, < 2 x ULN is allowed) within 2 weeks of registration
Bilirubin =< 2.5 x ULN (=< 4 x ULN for subjects with Gilbert’s disease)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) except for previously documented Gilbert’s disease, defined as a mild unconjugated hyperbilirubinemia with no other identifiable cause and bilirubin values < 6 mg/dL; patients with hyperbilirubinemia secondary to presumed Gilbert’s disease who are being considered for enrollment in the study MUST have a fractionated bilirubin included in their screening labs when determining eligibility
Total bilirubin =< 2.0 x institutional ULN, unless documented Gilbert’s syndrome
Serum total bilirubin =< 2 x ULN (except for patients with Gilbert’s Syndrome)
Total bilirubin ? 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin ? 3.0 x ULN
Total bilirubin =<1.5 x ULN (excepting Gilbert’s syndrome)
Bilirubin =< 1.5 x ULN, (Patients with documented Gilbert’s syndrome and conjugated bilirubin within the normal range may be allowed into the study; in this event, it will be documented that the patient was eligible based on\r\nconjugated bilirubin levels)
Bilirubin =< 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin =< 3.0 x ULN
Bilirubin: =< 1.5 x ULN (except for subjects with Gilbert’s Syndrome or of non-hepatic cause)
Total bilirubin < 2.5 ULN. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible.
Total bilirubin =< 1.5 x ULN (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 x ULN)
Total bilirubin ? ULN (except in patients who have Gilbert’s syndrome or patients with recently placed stents for biliary obstruction when bilirubin should be < 1.5 X ULN) obtained ? 14 days prior to randomization
Direct bilirubin (bili) =< 40% if total bili > ULN in patients with Gilbert’s syndrome
Known Gilbert’s disease
Patients with known Gilbert’s disease
Total bilirubin =< 1.5 x ULN (except if the patient has Gilbert’s syndrome who can have total bilirubin =< 2 x ULN) must be met during screening (within 21 days) and also prior to study drug administration on cycle 1 day 1
Total bilirubin =<1.5 X institutional ULN (or =< 3 X institutional ULN for patients with documented Gilberts syndrome) (unless dysfunction is secondary to lymphoma involvement)
Total bilirubin =< 1.5 x ULN (In the expansion cohort, subjects with Gilbert’s syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN).
Total bilirubin ? 1.5 x ULN (AST, ALT, and total bilirubin ? 3 × ULN in subjects with documented Gilbert’s syndrome or hyperbilirubinemia clearly attributed to lymphoma involvement of the liver)
ALT, AST > 2.5 ULN or total bilirubin > 1.5 ULN (not attributable to Gilbert’s)
Subjects with Gilbert’s syndrome, confirmed by genotyping or Invader UGTIA1 molecular assay prior to study entry, must have total bilirubin < 3.0 times ULN
Total bilirubin > or = 1.5 x ULN, unless due to Gilbert’s disease.
Total bilirubin =< 3 x ULN in patients with documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or in the presence of liver metastases
Direct bilirubin =< 1.5 x ULN except for i) patients with documented Gilbert’s syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range)
Bilirubin =< 1.5 x ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 x ULN
Total serum bilirubin =< 2.0 x ULN (except if Gilbert’s disease)
Bilirubin =< 1.0 x ULN (exceptions for Gilbert’s syndrome)
Within 14 days prior to registration: Total bilirubin =< 1.5 x ULN (except in patients with Gilbert’s disease)
Total bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)
PHASE II SCLC: Total bilirubin =< 1.5 x ULN (unless Gilbert’s disease)
UROTHELIAL CARCINOMA EXPANSION COHORT: Total bilirubin =< 1.5 x ULN (=< 3 x ULN for subjects with Gilbert’s disease)
mCRPC EXPANSION COHORT: Total bilirubin =< 1.5 x ULN (=< 3 x ULN for subjects with Gilbert’s disease)
Total serum bilirubin ? 1.5 x ULN (? 3.0 x ULN if Gilbert’s disease)
Total bilirubin > 2 x institutional ULN (except for known Gilbert’s syndrome/familial non-hemolytic jaundice)
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nTotal bilirubin =< 1.5 X ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 X ULN
Total serum bilirubin =< 1.5 x ULN (=< 3 x ULN for Gilbert’s syndrome)
Bilirubin =< 1.5 x ULN or =< 3 x ULN for subjects with documented/suspected Gilbert’s disease
Total bilirubin =< 1.5 x ULN for the laboratory (total bilirubin criteria may be waived if a patient has documented Gilbert’s disease)
Total bilirubin ? 1.5 x ULN (excepting Gilbert’s syndrome)
Within 14 days of first dose of study drug: Bilirubin =< 1.5 x ULN (< 2 x ULN if hyperbilirubinemia is due to Gilbert’s syndrome)
Bilirubin must be =< 1.5 x ULN, except participants with Gilbert’s syndrome where bilirubin must be =< 2.0 x ULN
BLADDER: Clinical laboratory values at screening: bilirubin ? 1.5 x the ULN; for subjects with known Gilbert’s disease, bilirubin ? 3.0 mg/dL
Total bilirubin =< 1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert’s syndrome, then =< 2.5 x ULN
Total bilirubin =< 1.5 x ULN for the laboratory; Note: Patients with known Gilbert’s syndrome are not eligible for this study
Total bilirubin =< 1.5 x ULN unless if evidence of indirect hyperbilirubinemia due to for example Gilbert’s syndrome
Total bilirubin =< 1.5 x ULN (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 ULN)
Total bilirubin =< 1.5 x ULN unless Gilbert’s syndrome of disease infiltration of the liver is present
Total bilirubin (TBil) and direct bilirubin (DBil) =< ULN with an exception of patients with confirmed Gilbert’s syndrome; for patients with confirmed Gilbert’s syndrome, the TBil should be =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN for the laboratory (total bilirubin criteria may be waived if a subject has documented Gilbert’s syndrome)
Total bilirubin within 1.5 x ULN, except those with Gilberts syndrome for whom this must be <3 x ULN
* Patients with a history of Gilbert’s syndrome may be eligible provided total bilirubin is less than or equal to 1.5 x ULN and the AST, ALT, and alkaline phosphatase meet the criteria detailed
Bilirubin =< 1.5 x ULN within 14 days prior to study registration; unless patient has Gilbert’s disease
Total bilirubin < 1.5 x ULN unless the patient has Gilbert’s syndrome, in which case total (T) bilirubin < 2.5 x ULN required
Total bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)
Bilirubin =< 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin =< 3.0 x ULN
Total-value bilirubin (TBil) and direct bilirubin (DBil) =< ULN with an exception of patients with confirmed Gilbert’s syndrome; for patients with confirmed Gilbert’s syndrome, the TBil should be =< 1.5 x ULN
Obtained =< 7 days prior to registration:\r\nTotal bilirubin =< 1.5 x ULN (does not apply to patients with isolated hyperbilirubinemia [e.g., Gilbert’s disease], in that case direct bilirubin should be =< 2 x ULN)
Serum bilirubin =< 1.5 x ULN (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total serum bilirubin =< 1.5 x ULN; patients with Gilbert’s syndrome with baseline serum bilirubin exceeding this limit are allowed to participate
Bilirubin < 2.0 x ULN, unless subject has Gilbert’s disease
Bilirubin must not be more than 1.5 x ULN (does not apply to patients with Gilbert’s disease)
Total bilirubin =< ULN (patient’s with Gilbert’s syndrome are eligible, even if total bilirubin is > ULN)
Bilirubin >= 3 x ULN (unless Gilbert’s syndrome)
Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 x ULN (does not apply to patients with isolated hyperbilirubinemia [e.g., Gilbert’s disease], in that case direct bilirubin should be =< 2 x ULN)
Total bilirubin =< 1.5 X ULN; patients with increased bilirubin due to Gilberts disease will not be excluded, if increased bilirubin is the only protocol exclusion criteria met
Total bilirubin =<1.5 x ULN unless increase is due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin
Total bilirubin =< 1.5 x ULN (< 3.0 x ULN in the presence of Gilbert’s disease)
Serum bilirubin =< 2 x the laboratory normal range (except for patients with Gilbert’s disease)
Bilirubin =< 1.5 x ULN, except in cases of patients with Gilbert’s disease, where =< 4 x ULN will be allowed
Total bilirubin =< 2.0 x ULN, unless elevated bilirubin is attributable to Gilbert’s syndrome or to HIV medications (e.g., indinavir, tenofovir, atazanavir)
Bilirubin =< 1.5 ULN (subjects with documented diagnosis of Gilbert’s syndrome are eligible provided total bilirubin < 3.0 x ULN)
Total bilirubin =< 2 x ULN, or < 5 ULN if Gilbert’s disease
Total bilirubin =< 2, unless due to Gilbert’s disease
Total bilirubin =< 2 x ULN (in the expansion cohort, patients with Gilbert’s syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN)
Bilirubin < 1.5 x ULN (unless Gilbert’s is suspected in which case total bilirubin < 3 x ULN)
Total serum bilirubin =< 1.5 x ULN (if documented Gilberts syndrome =< 3 x ULN) obtained =< 14 days prior to registration
Total bilirubin < 1.5 x ULN (if thought to be > 1.5 x ULN due to Gilbert’s disease or the patient’s AML, must discuss with the principal investigator [PI])
Serum bilirubin =< 4.0 x ULN or LLN (except for patients with Gilbert’s disease)
Greater than 3 x the ULN for total bilirubin (except for known cases of Gilbert’s syndrome, where the levels of conjugated bilirubin must be less than 3 x the ULN)