Total bilirubin within normal limits (must be obtained =< 2 weeks prior to randomization)
Total bilirubin < 1.5 x upper limits of normal (ULN)
Within 14 days of registration: Bilirubin =< 1.5 x upper limits of normal (ULN)
Total bilirubin < 1.5 x upper limits of normal (ULN)
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin < 1.5 x upper limits of normal (ULN)
Bilirubin =< 2.0 x upper limits of normal (ULN)
Total bilirubin =< 1.5 x upper limits of normal (ULN) (=< 28 days prior to registration)
Bilirubin ? 1.5 x upper limits of normal
PIK3CA WILD TYPE COHORT (closed 03/17/2016): Total bilirubin =< upper normal institutional limits
ENDOCRINE RESISTANT AND ADJUVANT COHORT: Total bilirubin =< upper normal institutional limits
Bilirubin should be within normal limits (CTCAE v4.0, grade 1)
Total bilirubin =< 1.5 x upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Bilirubin < 1.5 x upper limits of normal (ULN)
Total bilirubin =< 1.5 mg/dL X institutional upper limits of normal (ULN)
Total bilirubin < 2.5 times the upper limits of normal (ULN)
Hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits, LDH, SGOT and SGPT>2 times upper limits of normal or albumin <3.5 g/dL.
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN) except for patients with Gilbert’s disease
Bilirubin =< 1.5 times upper limits of normal (ULN)
For pts with liver metastasis: total bilirubin outside of normal limits
Total bilirubin outside of normal limits
Total bilirubin =< 1.5 X upper limits of normal
Total bilirubin with normal institutional limits; NOTE: for this study, subjects with bilirubin levels > 1.5 upper limit of normal (ULN) are excluded from this enrollment in this study
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Normal serum total bilirubin (lower and upper limits of local Laboratory)
Bilirubin within normal limits unless patients has Gilbert’s disease and then bilirubin =< 3 x upper limits of normal (ULN)
Serum total bilirubin > 2.0 and/or serum transaminases > 3 X the upper limits of normal
Total bilirubin < 2.0 x the upper limit of normal and direct bilirubin within normal limits
Serum SGOT/AST <3.0 x upper limits of normal (ULN)
Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
Serum total bilirubin =< 2X the upper limits of normal (ULN).
TSH within normal limits at baseline, (if not WLN, then total T3 or free T3 and free T4 should be within normal limits) or stable with treatment.
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin: within normal limits at each study site local laboratory
Performed within 14 days prior to study: Bilirubin < 3 times the upper limits of the institutional normal
Bilirubin =< 1.5 x upper limits of normal
Total bilirubin < 1.5 x upper limits of normal
Total bilirubin =< 1.5 x upper limits of normal (ULN)
Aspartate aminotransferase (AST) =< 2.5 x upper limits of normal (ULN); for patients with liver metastasis: =< 5 x upper limits of normal (ULN)
Total bilirubin ? 1.5 x Upper Limits of Normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin ? 1.5 x the upper limits of normal (ULN)
Bilirubin, AST and ALT not more than 2 x Upper Limits of Normal
Total bilirubin within 3 times the upper limits of normal
Total serum bilirubin within normal limits regardless of liver metastases
Total bilirubin outside of normal limits; for pts with liver metastasis: total bilirubin outside of normal limits
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 2.0 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x upper limits of normal (ULN)
Patients must have the following laboratory values: ANC greater than 1500/mcL, platelet count greater than 100,000/mcL, hemoglobin greater than 10 g/dL, bilirubin less than 1.5 x upper limits of normal, AST less than 1.5 x upper limits of normal
REGISTRATION INCLUSION CRITERIA: Total bilirubin within institutional upper limits of normal unless related to primary disease
Serum bilirubin > 1.5 x upper limits of normal (ULN)
total bilirubin <1.5X upper limits of normal
Total bilirubin =< 2 X institutional upper limits of normal (ULN)
Part A: Serum alpha fetoprotein greater than or equal to 1.5 Upper Limits of Normal, Part B: Serum alpha fetoprotein less than 1.5 Upper Limits of Normal. Not applicable for Part C or D
Serum SGOT/AST <3.0 x upper limits of normal (ULN)
Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
Subject with liver failure as defined by a serum total bilirubin > 2.0 and/or serum transaminases > 3 x the upper limits of normal
Bilirubin =< 1.5 x normal limits
Bilirubin within normal limits within 90 days prior to registration
total bilirubin within normal institutional limits (or <2X the upper limit of normal in those with Gilbert's disease)
Total bilirubin outside of normal limits; for patients (pts) with liver metastasis: total bilirubin outside of normal limits
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
TREATMENT: Total bilirubin < 1.5 x upper limits of normal
Serum total bilirubin is less than or equal to the upper limits of normal
Total Bilirubin ? 1.5 x upper limits of normal
AST (SGOT) ? 2.5 x upper limits of normal
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin < 1.5 x upper limits of normal
Total bilirubin =< 1.5 x upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Bilirubin =< 1.5 x upper limits of normal
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin < 1.5 x upper limits of normal
Total bilirubin < 2.0 x upper limits of normal
Bilirubin > 2.0 x ULN (institutional upper limits of normal)
Bilirubin > 1.5 x ULN (institutional upper limits of normal)
Bilirubin =< 2.5 x upper limits of normal if no liver metastases present; serum total bilirubin must be =< 3 x upper limits of normal for patients with Gilbert disease; total bilirubin =< 5 x upper limits of normal if liver metastases present
Bilirubin > 1.5 x institutional upper limits of normal (ULN)
Total bilirubin =< 1.5x upper limit of normal (ULN) (or if =< 4 gm/dL and direct bilirubin is within normal limits [WNL])
Bilirubin within normal limits