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| a | b/clusters/3009knumclusters/clust_105.txt | ||
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| 1 | Total bilirubin =< 1.5 x normal institutional limits; this will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia [predominantly unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician |
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| 2 | Total bilirubin within normal limits (must be obtained =< 2 weeks prior to randomization) |
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| 3 | Bilirubin =< 1.5 x institutional upper limits of normal (ULN); if patient has documented Gilbert’s syndrome bilirubin must be < 3 x institutional ULN |
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| 4 | Total bilirubin within normal institutional limits |
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| 5 | Total bilirubin < 1.5 x upper limits of normal (ULN) |
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| 6 | Serum bilirubin =< 1.5 x institutional upper limits of normal (ULN); must be obtained within 28 days prior to registration |
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| 7 | Within 14 days of registration: Bilirubin =< 1.5 x upper limits of normal (ULN) |
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| 8 | Total bilirubin < 1.5 x upper limits of normal (ULN) |
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| 9 | RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin < 1.5 x upper limits of normal (ULN) |
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| 10 | Creatinine no greater than the institutional upper limits of normal |
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| 11 | Bilirubin =< 2.0 x upper limits of normal (ULN) |
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| 12 | Obtained within 14 days prior to treatment start: Potassium (K) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 13 | Obtained within 14 days prior to treatment start: Total calcium (CA) (corrected for serum albumin) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 14 | Obtained within 14 days prior to treatment start: Magnesium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 15 | Obtained within 14 days prior to treatment start: Sodium (NA) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 16 | Obtained within 14 days prior to treatment start: Phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 17 | total bilirubin within normal institutional limits |
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| 18 | Patients must have serum creatinine =< 2 x institutional upper limits of normal (IULN) within 7 days prior to registration |
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| 19 | Total bilirubin within normal institutional limits |
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| 20 | Serum bilirubin less than two times the institutional upper limits of normal (ULN); higher levels are acceptable if these can be attributed to active hemolysis, ineffective erythropoiesis, or Gilbert’s disease |
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| 21 | Total bilirubin within normal institutional limits |
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| 22 | Total bilirubin =< 1.5 x upper limits of normal (ULN) (=< 28 days prior to registration) |
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| 23 | Total bilirubin within normal institutional limits |
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| 24 | Creatinine within 1.5 x the ULN institutional limits |
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| 25 | Total bilirubin within normal institutional limits within 14 days of registration |
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| 26 | Creatinine within normal institutional limits |
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| 27 | Serum bilirubin =< 2.5 times ULN except for participants who are on atazanavir or indinavir, provided that the participant’s direct bilirubin is within normal institutional limits |
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| 28 | Creatinine ? 1.5 x upper limits of normal |
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| 29 | Bilirubin ? 1.5 x upper limits of normal |
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| 30 | Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 31 | Total bilirubin within normal institutional limits |
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| 32 | Adequate organ function as defined by System Laboratory Values; Hematologic (Absolute neutrophil count [ANC] >=1.5x10^9/ liter [L], Lymphocyte count >1,000/cubic millimeter [mm^3], Hemoglobin >=9 grams/deciliter [g/dL], Platelets >=100x10^9/L), Hepatic (Total bilirubin <=1.5x upper limit of normal [ULN] [For subjects with Gilbert's Syndrome, only if direct bilirubin <=35%, <=3.0xULN], alanine aminotransferase [ALT] <=1.5xULN); Renal (Serum Creatinine <=1.5xULN OR Calculated creatinine clearance [CrCl >50 mL/min) and Endocrine (Thyroid stimulating hormone [TSH] within normal limits. If TSH is not within normal limits at baseline, the subject may still be eligible if total T3 or free T3 and free T4 are within the normal limits. |
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| 33 | Potassium, total calcium (corrected for serum albumin), magnesium, and phosphorus within normal limits for the institution or corrected to within normal limits with supplements |
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| 34 | Total bilirubin within normal institutional limits (or < 2 X the upper limit of normal in those with Gilbert’s disease) |
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| 35 | Potassium, total calcium (corrected for serum albumin), magnesium, and sodium within normal limits for the institution or corrected to within normal limits before first dose of study medication |
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| 36 | Total bilirubin within normal laboratory limits |
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| 37 | Creatinine within normal laboratory limits |
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| 38 | Total bilirubin within normal institutional limits |
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| 39 | Total bilirubin =< upper normal institutional limits |
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| 40 | Creatinine =< upper normal institutional limits |
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| 41 | PIK3CA WILD TYPE COHORT (closed 03/17/2016): Total bilirubin =< upper normal institutional limits |
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| 42 | PIK3CA WILD TYPE COHORT (closed 03/17/2016): Creatinine =< upper normal institutional limits |
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| 43 | ENDOCRINE RESISTANT AND ADJUVANT COHORT: Total bilirubin =< upper normal institutional limits |
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| 44 | ENDOCRINE RESISTANT COHORT: Creatinine =< upper normal institutional limits |
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| 45 | Bilirubin should be within normal limits (CTCAE v4.0, grade 1) |
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| 46 | Free T4 within institutional normal limits. |
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| 47 | Total bilirubin within normal institutional limits |
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| 48 | Creatinine within normal institutional limits |
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| 49 | Total serum bilirubin within normal institutional limits |
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| 50 | Serum creatinine within normal institutional limits OR |
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| 51 | Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 52 | Creatinine within normal institutional limits |
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| 53 | Total bilirubin within normal institutional limits |
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| 54 | Total bilirubin within normal institutional limits |
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| 55 | Within 2 weeks prior to initiation of study treatment: Total bilirubin within normal institutional limits |
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| 56 | Total bilirubin =< 1.5 x upper limits of normal (ULN) |
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| 57 | Creatinine within institutional normal limits |
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| 58 | Bilirubin must be within or below normal institutional limits |
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| 59 | Patients must have the following laboratory values within the laboratory normal limits or corrected to within normal limits with supplements during screening:\r\n* Potassium\r\n* Magnesium\r\n* Phosphorus\r\n* Total calcium (corrected for serum albumin) |
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| 60 | Total bilirubin within normal institutional limits |
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| 61 | Total bilirubin within normal institutional limits |
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| 62 | Total bilirubin within 1.5 times normal institutional limits |
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| 63 | Total Ca (corrected for serum albumin) w/in normal limits |
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| 64 | COHORT I: Total bilirubin within normal institutional limits |
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| 65 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
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| 66 | Total bilirubin within normal limits; |
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| 67 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
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| 68 | Total bilirubin within normal institutional limits |
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| 69 | Total bilirubin within normal institutional limits unless due to Gilbert’s disease |
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| 70 | Bilirubin < 1.5 x upper limits of normal (ULN) |
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| 71 | Total bilirubin must be within normal limits. |
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| 72 | Total bilirubin within normal institutional limits |
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| 73 | Bilirubin =< 1.5 x institutional limits |
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| 74 | PART II: PT/PTT =< 1.5 x the upper limits of normal |
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| 75 | Total bilirubin within normal institutional limits |
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| 76 | Creatinine within normal institutional limits |
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| 77 | LVEF at or above institutional lower limits of normal (>= 50%), or at least 5% above lower limits of normal if prior anthracycline exposure (by echocardiogram or nuclear scan within 12 weeks of registration) |
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| 78 | Serum calcium within normal institutional limits |
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| 79 | Serum phosphorus within normal institutional limits |
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| 80 | Have adequate organ function, including: Absolute neutrophil count (ANC) at least 1.5 x 109/Liter (L), platelets at least 100 x 109/L, and hemoglobin at least 8 grams/deciliter (g/dL); bilirubin no more than 1.5 times upper limits of normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no more than 2.0 times upper limits of normal; Serum creatinine no more than 1.5 times upper limits of normal or calculated creatinine clearance >45 milliliters/minute (mL/min) |
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| 81 | Creatinine within normal institutional limits OR |
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| 82 | Creatinine within 1.5 x normal institutional limits. |
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| 83 | ARM I&II: Transaminases =< times above the upper limits of the institutional normal |
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| 84 | Total bilirubin within normal institutional limits; in patients with Gilbert’s, ? 3.0 mg/dL |
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| 85 | Creatinine within 1.5 x upper limit of normal institutional limits |
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| 86 | PTT & INR within institutional limits. |
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| 87 | Total bilirubin within normal institutional limits |
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| 88 | Total bilirubin within normal institutional limits |
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| 89 | Serum sodium and potassium within the institutional limits of normal, within 14 days of registration and within 7 days of the start of treatment |
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| 90 | Normal organ and marrow function: Leukocytes ? 3000/?L, Absolute neutrophil count ? 1500/?L, Platelets ? 100,000/?L, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ? 2.0 x ULN, AST(SGOT)/ALT (SGPT) ? 1.5 x institutional ULN, creatinine < 1.5 x institutional ULN |
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| 91 | Total bilirubin =< 1.5 x normal institutional limits; for patients (Pts) with liver metastasis: total bilirubin must be within normal limits; (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) |
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| 92 | Potassium within normal limits (WNL) |
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| 93 | Total bilirubin =< 1.5 mg/dL X institutional upper limits of normal (ULN) |
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| 94 | Total bilirubin within 1.5 x normal institutional limits |
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| 95 | Creatinine within 1.5 x normal institutional limits |
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| 96 | Total bilirubin < 2.5 times the upper limits of normal (ULN) |
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| 97 | Serum sodium within normal limits or corrected to within normal limits with supplements before starting treatment |
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| 98 | Potassium within normal limits or corrected to within normal limits with supplements before starting treatment |
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| 99 | Magnesium within normal limits or corrected to within normal limits with supplements before starting treatment |
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| 100 | Phosphorus within normal limits or corrected to within normal limits with supplements before starting treatment |
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| 101 | Total Bilirubin within normal institutional limits |
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| 102 | Magnesium within 0.85 to 1.25 x institutional normal limits |
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| 103 | Potassium within institutional normal limits |
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| 104 | Total bilirubin within normal institutional limits |
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| 105 | Total bilirubin within normal institutional limits |
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| 106 | Clotting parameters within normal limits or maximum 25% outside of the the normal ranges |
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| 107 | Total bilirubin within normal institutional limits |
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| 108 | 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. |
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| 109 | Total bilirubin within normal institutional limits 14 days or fewer from registration |
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| 110 | Total bilirubin =< 1.5 X institutional upper limits of normal; total bilirubin > 1.5 X above institutional upper limits of normal will be allowed if direct bilirubin is within normal limits or if patients has a documented history of Gilbert’s disease |
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| 111 | Creatinine within normal institutional limits OR |
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| 112 | Total bilirubin within normal institutional limits |
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| 113 | Total bilirubin within normal institutional limits |
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| 114 | Serum creatinine =< 1.5 x normal institutional limits |
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| 115 | serum troponin T levels within normal limits; |
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| 116 | Total bilirubin within normal institutional limits |
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| 117 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
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| 118 | Total bilirubin within normal institutional limits |
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| 119 | Potassium, total calcium (corrected for serum albumin), magnesium, and sodium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 120 | Total bilirubin within normal institutional limits |
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| 121 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) except for patients with Gilbert’s disease |
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| 122 | Total bilirubin within 1.5 x normal institutional limits |
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| 123 | Serum calcium, magnesium, and phosphorous with institutional normal limits (supplementation is permissible) |
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| 124 | Within 14 days of registration: Bilirubin within normal institutional limits (or < 2 X the upper limit of normal (ULN) in those with Gilbert’s disease) |
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| 125 | Total bilirubin within normal institutional limits |
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| 126 | Total bilirubin within normal institutional limits |
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| 127 | To be performed within 10 business days prior to day 1: Total bilirubin within 1.5 x the upper limit of normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible |
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| 128 | Creatinine within normal institutional limits, assessed within 14 days prior to registration OR |
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| 129 | Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 130 | Potassium within normal limits prior to the first dose of study medication |
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| 131 | Magnesium within normal limits prior to the first dose of study medication |
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| 132 | Total calcium (corrected for serum albumin) within normal limits prior to the first dose of study medication |
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| 133 | Total bilirubin within normal institutional limits |
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| 134 | Bilirubin =< 1.5 times upper limits of normal (ULN) |
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| 135 | Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication |
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| 136 | Total bilirubin within normal institutional limits |
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| 137 | For pts with liver metastasis: total bilirubin outside of normal limits |
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| 138 | Total bilirubin outside of normal limits |
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| 139 | Total bilirubin within normal institutional limits unless thought due to hemolysis or to Gilbert’s syndrome |
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| 140 | PHASE II: Serum creatinine within normal institutional limits |
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| 141 | Total bilirubin within normal institutional limits |
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| 142 | Creatinine within normal institutional limits |
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| 143 | Serum calcium & phosphorus within normal institutional limits |
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| 144 | Glucose within normal institutional limits |
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| 145 | Total bilirubin within normal institutional limits |
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| 146 | Total bilirubin within normal institutional limits |
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| 147 | Total bilirubin within normal institutional limits |
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| 148 | Total bilirubin =< 1.5 X upper limits of normal |
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| 149 | Total bilirubin within normal institutional limits |
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| 150 | Creatinine < 1.5 x institutional upper limits of normal (ULN) |
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| 151 | Total bilirubin =< 2.5 X institutional limits |
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| 152 | Transaminases =< 2 times above the upper limits of the institutional normal |
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| 153 | Creatinine within normal institutional limits OR according to Johns Hopkins MRI policy |
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| 154 | Inorganic phosphorus outside of normal limits |
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| 155 | Total and ionized serum calcium outside of normal limits |
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| 156 | Creatinine =< 1.5 X upper limits of normal |
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| 157 | Total bilirubin within normal institutional limits |
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| 158 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
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| 159 | Normal serum total bilirubin (lower and upper limits of local Laboratory) |
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| 160 | Total bilirubin within normal institutional limits |
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| 161 | Creatinine within normal institutional limits OR |
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| 162 | Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 163 | Bilirubin within normal limits unless patients has Gilbert’s disease and then bilirubin =< 3 x upper limits of normal (ULN) |
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| 164 | Total bilirubin within normal institutional limits |
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| 165 | Creatinine within normal institutional limits OR |
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| 166 | Total bilirubin within normal institutional limits (unless Gilbert’s disease with elevated indirect bilirubin only) |
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| 167 | Creatinine within or below normal institutional limits |
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| 168 | PHASE I STUDY ELIGIBILITY CRITERIA:\r\nTotal bilirubin =< 1.5 X the normal institutional limits |
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| 169 | Aspartate aminotransferase (AST) < 5.0 x normal institutional limits within 14 days of study entry |
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| 170 | Creatinine =< 1.5 X upper limits of normal (ULN) |
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| 171 | Serum total bilirubin > 2.0 and/or serum transaminases > 3 X the upper limits of normal |
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| 172 | Total bilirubin within normal institutional limits |
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| 173 | Bilirubin < 1.5 x institutional normal for age |
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| 174 | Total bilirubin within normal institutional limits, determined within 14 days of registration |
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| 175 | Total bilirubin within normal institutional limits |
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| 176 | Total bilirubin within normal institutional limits |
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| 177 | Bilirubin >= 2 x institutional upper limit of normal\r\n* Total bilirubin within normal institutional limits |
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| 178 | Liver function criteria: AST and ALT =< 2.5 times the institutional upper limits of normal |
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| 179 | Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed) |
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| 180 | Potassium within normal limits for the institution |
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| 181 | Total bilirubin within normal institutional limits |
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| 182 | Total bilirubin within normal institutional limits |
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| 183 | Total bilirubin within normal institutional limits |
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| 184 | Creatinine within normal institutional limits OR |
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| 185 | Total bilirubin within normal institutional limits |
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| 186 | For Phase I and II: Serum potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limits. |
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| 187 | Newly diagnosed MCL: Uric acid within normal limits (allopurinol is allowed to bring abnormal level to within normal limits) |
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| 188 | Total bilirubin within normal institutional limits |
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| 189 | Serum creatinine < 2.0 x the upper limits of institutional normal (ULN) |
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| 190 | Total bilirubin < 1.5 x the upper limits of institutional normal |
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| 191 | Bilirubin =< 1.5 x institutional normal for age |
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| 192 | Total bilirubin =< 1.5 X normal institutional limits (within 2 weeks prior to radiotherapy) |
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| 193 | Total bilirubin within normal institutional limits |
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| 194 | Total bilirubin within normal institutional limits (except for participants with Gilbert’s disease) |
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| 195 | Within 4 weeks of preregistration: Total bilirubin =< upper normal institutional limits (except for patients with Gilbert’s disease who are eligible despite elevated serum bilirubin level) |
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| 196 | ELIGIBILITY CRITERIA FOR REGISTRATION: total bilirubin =< upper normal institutional limits (except for patients with Gilbert’s disease who are eligible despite elevated serum bilirubin level) (within one week of registration if patient postop, otherwise within two weeks of registration) |
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| 197 | Total bilirubin within normal institutional limits |
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| 198 | Bilirubin =< 1.5x institutional normal for age |
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| 199 | Prothrombin time (PT) within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasty |
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| 200 | Partial thromboplastin time (PTT) within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasty |
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| 201 | Total bilirubin within normal institutional limits |
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| 202 | Thyroid function is within normal limits |
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| 203 | Total bilirubin =< 1.5 x normal institutional limits; this last criterion will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia [predominantly unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician |
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| 204 | Potassium, Magnesium, Phosphorus, total Calcium (corrected for serum albumin) outside of normal limits (patients may be enrolled if corrected to within normal limits with supplements during screening) |
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| 205 | Serum SGOT/AST <3.0 x upper limits of normal (ULN) |
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| 206 | Serum SGPT/ALT <3.0 x upper limits of normal (ULN) |
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| 207 | Total bilirubin within normal limits |
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| 208 | Creatinine within normal limits |
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| 209 | Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed) |
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| 210 | Potassium within normal limits for the institution |
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| 211 | total bilirubin within normal institutional limits |
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| 212 | Troponin blood level within normal limits. |
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| 213 | Serum total bilirubin =< 2X the upper limits of normal (ULN). |
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| 214 | 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. |
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| 215 | Total bilirubin within normal institutional limits |
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| 216 | Creatinine within normal institutional limits |
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| 217 | Urinalysis within normal institutional limits |
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| 218 | Serum creatinine < 2.0 x the upper limits of institutional normal (ULN) |
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| 219 | Total bilirubin < 1.5 x the upper limits of institutional normal |
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| 220 | Cardiac function within institutional normal limits on echocardiogram |
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| 221 | Total bilirubin within normal institutional limits |
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| 222 | Creatinine within normal institutional limits OR |
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| 223 | Total bilirubin within normal institutional limits |
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| 224 | Total bilirubin within normal institutional limits |
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| 225 | Total bilirubin within normal institutional limits |
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| 226 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
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| 227 | Total bilirubin within normal institutional limits |
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| 228 | Total bilirubin: within normal limits at each study site local laboratory |
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| 229 | Total bilirubin within normal institutional limits |
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| 230 | Performed within 14 days prior to study: Alanine aminotransferase (ALT) < 3 times the upper limits of the institutional normal |
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| 231 | Performed within 14 days prior to study: Aspartate aminotransferase (AST) < 3 times the upper limits of the institutional normal |
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| 232 | Performed within 14 days prior to study: Bilirubin < 3 times the upper limits of the institutional normal |
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| 233 | Total bilirubin within normal institutional limits |
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| 234 | Creatinine =< 1.5 x upper limits of normal |
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| 235 | Bilirubin =< 1.5 x upper limits of normal |
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| 236 | Total bilirubin within normal institutional limits |
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| 237 | DOSE ESCALATION COHORT: Total bilirubin within normal institutional limits |
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| 238 | DOSE EXPANSION COHORT: Total bilirubin within normal institutional limits |
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| 239 | Total bilirubin up to 1.5 X institutional normal reference range |
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| 240 | Albumin within normal limits |
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| 241 | Total bilirubin within normal institutional limits |
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| 242 | Creatinine within normal institutional limits OR |
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| 243 | Total bilirubin within normal institutional limits |
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| 244 | Total bilirubin within normal institutional limits |
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| 245 | Total bilirubin < 1.5 x upper limits of normal |
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| 246 | Potassium within normal limits for the institution, or corrected with supplements |
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| 247 | Total bilirubin within normal institutional limits |
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| 248 | Creatinine within normal institutional limits OR |
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| 249 | Total bilirubin within normal institutional limits |
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| 250 | Total bilirubin =< 2 X normal institutional limits |
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| 251 | Total bilirubin within normal institutional limits |
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| 252 | Total bilirubin within normal institutional limits |
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| 253 | Potassium within normal limits (oral supplementation is allowed) |
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| 254 | Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
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| 255 | Total bilirubin within normal institutional limits |
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| 256 | Total bilirubin within normal institutional limits |
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| 257 | Total bilirubin within normal institutional limits |
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| 258 | Creatinine =< 2 x institutional upper limits of normal |
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| 259 | Serum magnesium within normal limits |
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| 260 | Serum potassium within normal limits |
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| 261 | Serum sodium within normal limits |
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| 262 | Serum calcium within normal limits |
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| 263 | Total serum bilirubin within normal institutional limits |
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| 264 | Total bilirubin within normal institutional limits |
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| 265 | Total bilirubin within normal institutional limits (unless isolated indirect hyperbilirubinemia due to Gilbert’s disease) |
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| 266 | Total bilirubin within normal limits |
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| 267 | Total bilirubin within normal limits |
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| 268 | Thyroid stimulating hormone (TSH) within institutional limits (ie: normal); if TSH is greater or less than institutional limits patients may participate if their T4 is within normal limits (WNL); patients may be on a stable dose of replacement thyroid medication; dose adjustments are allowed if needed |
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| 269 | Total bilirubin within normal institutional limits |
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| 270 | Creatinine =< 1.5 x upper limits of normal (ULN) |
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| 271 | Total bilirubin =< 1.5 x upper limits of normal (ULN) |
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| 272 | Aspartate aminotransferase (AST) =< 2.5 x upper limits of normal (ULN); for patients with liver metastasis: =< 5 x upper limits of normal (ULN) |
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| 273 | PT, PTT (in seconds) not to be prolonged beyond >20% of the upper limits of normal. |
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| 274 | Total bilirubin ? 1.5 x Upper Limits of Normal (ULN) |
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| 275 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
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| 276 | Total bilirubin =< normal institutional limits |
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| 277 | Creatinine =< normal institutional limits OR |
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| 278 | Total bilirubin within normal institutional limits |
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| 279 | Bilirubin =< 1.5 x institutional normal |
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| 280 | Potassium within normal limits or correctable with supplements. |
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| 281 | Total bilirubin within normal institutional limits, patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible |
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| 282 | Serum potassium within institutional limits of normal (may be corrected with potassium repletion) |
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| 283 | Bilirubin within institutional normal limits |
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| 284 | Total bilirubin within normal institutional limits or < 3 x the upper limit of normal in patients with Gilbert’s disease |
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| 285 | Total bilirubin ? 1.5 x the upper limits of normal (ULN) |
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| 286 | Total bilirubin within institutional normal limits (or < 2.5 X the ULN for patients with Gilbert’s disease) |
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| 287 | Bilirubin, AST and ALT not more than 2 x Upper Limits of Normal |
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| 288 | Patients have the following laboratory values outside of the laboratory normal limits or cannot be corrected to within normal limits with supplements during screening: Potassium, Magnesium, Phosphorus, Total calcium (corrected for serum albumin) |
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| 289 | Total bilirubin within normal institutional limits |
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| 290 | Bilirubin =< 1.5 x upper limits of normal (unless due to liver involvement, hemolysis, or Gilbert’s disease) |
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| 291 | Total bilirubin within normal institutional limits |
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| 292 | Obtained within 30 days of registration: Total bilirubin within normal institutional limits (may be elevated if direct bilirubin normal) |
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| 293 | Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within institutional upper limit of normal (IULN) or corrected to within normal limits with supplements before first dose of study medication; (supplements used for this purpose to be approved by primary investigator [PI]) |
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| 294 | Total bilirubin within normal institutional limits within 4 weeks of pre-registration |
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| 295 | Total bilirubin within 3 times the upper limits of normal |
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| 296 | Total serum bilirubin within normal limits regardless of liver metastases |
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| 297 | Total bilirubin outside of normal limits; for pts with liver metastasis: total bilirubin outside of normal limits |
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| 298 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
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| 299 | Total bilirubin within normal institutional limits |
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| 300 | Total bilirubin within normal institutional limits |
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| 301 | Renal insufficiency: anything over institutional normal limits for creatinine that is also clinically documented |
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| 302 | Total bilirubin must be within 1.5 X the normal institutional limits; if total bilirubin is outside the normal institutional limits, assess direct bilirubin |
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| 303 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
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| 304 | Total bilirubin within normal limits (WNL) for the institution, unless the bilirubin abnormality is considered due to Gilbert's syndrome. |
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| 305 | Total bilirubin within normal institutional limits |
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| 306 | Thyroid stimulating hormone (TSH) within institutional limits (i.e.: normal); if TSH is greater or less than institutional limits patients may participate if their T4 is within normal limits (WNL); patients may be on a stable dose of replacement thyroid medication; dose adjustments are allowed if needed (labs should be performed within 14 days of treatment initiation) |
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| 307 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
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| 308 | Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed) |
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| 309 | Potassium within normal limits for the institution |
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| 310 | Total bilirubin within normal institutional limits (unless known Gilbert’s syndrome) |
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| 311 | Serum sodium within normal limits |
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| 312 | Total bilirubin within normal institutional limits |
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| 313 | Within 14 days of registration: Creatinine within normal institutional limits OR |
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| 314 | Total bilirubin =< 2.0 x the upper limits of normal (ULN) |
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| 315 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
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| 316 | Total bilirubin =< 1.5 x upper limits of normal (ULN) |
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| 317 | Bilirubin within the institutional limits of normal |
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| 318 | 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 |
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| 319 | PHASE I: Total bilirubin within normal institutional limits |
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| 320 | PHASE II: Total bilirubin within normal institutional limits |
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| 321 | Total bilirubin up to 1.5 X institutional upper limits of normal (IULN) |
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| 322 | Creatinine < 2 x institutional limits |
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| 323 | Total bilirubin within normal institutional limits |
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| 324 | Serum potassium and magnesium-within normal limits (WNL) |
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| 325 | Bilirubin =< 1.5 X institutional limits |
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| 326 | Serum potassium, magnesium and calcium within normal limits (supplementation to maintain normal electrolyte levels is acceptable) |
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| 327 | Total bilirubin within normal institutional limits |
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| 328 | Creatinine =< 2 x upper limits of normal (ULN) |
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| 329 | Total bilirubin within institutional normal limits |
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| 330 | Total bilirubin within institutional normal limits |
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| 331 | Potassium within normal limits or correctable with supplements |
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| 332 | Total calcium (corrected for serum albumin) within normal limits |
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| 333 | Potassium within normal limits for the institution |
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| 334 | Total bilirubin within normal institutional limits |
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| 335 | Patients must have normal organ and marrow function as defined below: leukocytes ?3,000/mcL, absolute neutrophil count ?1,500/mcL, platelets ?100,000/mcL, total bilirubin within normal institutional limits, aspartate aminotransferase AST(SGOT)/ alanine aminotransferase ALT(SGPT) ?2.5 X institutional upper limit of normal, creatinine within normal institutional limits OR creatinine clearance ?60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal. |
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| 336 | Obtained within 2 weeks from study entry: Creatinine =< 1.5 X upper limits of normal |
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| 337 | Potassium within normal limits |
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| 338 | Total calcium (corrected for serum albumin) within normal limits or corrected with supplements |
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| 339 | REGISTRATION INCLUSION CRITERIA: Total bilirubin within institutional upper limits of normal unless related to primary disease |
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| 340 | Total bilirubin within normal institutional limits |
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| 341 | Total bilirubin =< the institutional upper limit of normal (exception permitted in patients with Gilbert’s syndrome after discussion with study principal investigator [PI], on a case by case basis and if liver function tests are within normal limits) |
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| 342 | Total bilirubin < 1.5 x normal institutional limits |
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| 343 | Patients must have the following electrolyte values ? LLN (lower limit of normal) limits or corrected to within normal limits with supplements prior to the first dose of study medication: |
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| 344 | Free thyroxine (T4) within normal limits |
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| 345 | Creatinine within normal institutional limits OR |
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| 346 | Serum bilirubin > 1.5 x upper limits of normal (ULN) |
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| 347 | Total bilirubin =< institutional upper limits of normal |
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| 348 | total bilirubin <1.5X upper limits of normal |
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| 349 | creatinine within normal institutional limits OR |
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| 350 | Total bilirubin =< 1.5 x institutional limits unless documented Gilbert's syndrome (then < 2.5 x institutional upper limit) |
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| 351 | Total bilirubin within normal institutional limits |
||
| 352 | Total bilirubin within normal institutional limits |
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| 353 | Creatinine < 1.5 x institutional upper limits of normal |
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| 354 | Serum phosphorus >= lower limits of normal (LLN) |
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| 355 | Liver function tests >= 2 times the institutional upper limits of normal |
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| 356 | Total bilirubin within normal institutional limits |
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| 357 | Obtained within 14 days prior to registration: Bilirubin within the institutional limits of normal |
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| 358 | Total bilirubin =< 2 X institutional upper limits of normal (ULN) |
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| 359 | Total bilirubin =< 1.5 x normal institutional limits |
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| 360 | Creatinine =< 2 x normal institutional limits |
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| 361 | Total bilirubin =< 1.5 x normal institutional limits |
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| 362 | Serum calcium, magnesium, potassium within normal limits, or if outside of normal limits, must be deemed clinically insignificant by the investigator |
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| 363 | Total bilirubin within normal institutional limits |
||
| 364 | Total bilirubin within normal institutional limits |
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| 365 | 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 |
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| 366 | Serum potassium within normal limits (WNL) |
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| 367 | Total bilirubin =< 1.5 X normal institutional limits |
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| 368 | EXPANSION COHORT ONLY: Total bilirubin =< 1.5 X normal institutional limits |
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| 369 | Serum SGOT/AST <3.0 x upper limits of normal (ULN) |
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| 370 | Serum SGPT/ALT <3.0 x upper limits of normal (ULN) |
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| 371 | Subject with liver failure as defined by a serum total bilirubin > 2.0 and/or serum transaminases > 3 x the upper limits of normal |
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| 372 | Total bilirubin within 1.5 times the upper limit of normal institutional limits |
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| 373 | Troponin T or I within normal institutional limits |
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| 374 | Potassium (K) levels: preferred normal limits with no clinical abnormalities |
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| 375 | Magnesium (Mg) levels: preferred normal limits with no clinical abnormalities |
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| 376 | Potassium levels within normal limits |
||
| 377 | Magnesium levels within normal limits |
||
| 378 | Bilirubin =< 1.5 x normal limits |
||
| 379 | Hepatic Function: Bilirubin ? 1.5 times institutional normal; SGPT (ALT) < 3 times institutional normal |
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| 380 | Serum creatinine within normal limits within 90 days prior to registration |
||
| 381 | Bilirubin within normal limits within 90 days prior to registration |
||
| 382 | Total bilirubin within normal institutional limits |
||
| 383 | Total bilirubin\r\n* For patients on FOLFIRI, within normal limits\r\n* For patients on FOLFOX, =< 3 X normal institutional limits |
||
| 384 | Total bilirubin within normal institutional limits |
||
| 385 | Total bilirubin within normal institutional limits |
||
| 386 | total bilirubin within normal institutional limits (or <2X the upper limit of normal in those with Gilbert's disease) |
||
| 387 | creatinine within normal institutional limits OR |
||
| 388 | Total bilirubin within normal institutional limits |
||
| 389 | Total bilirubin outside of normal limits; for patients (pts) with liver metastasis: total bilirubin outside of normal limits |
||
| 390 | Total calcium (corrected for serum albumin) within normal limits (biphosphonate use for malignant hypercalcemia control is not allowed) |
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| 391 | Potassium within normal limits for the institution |
||
| 392 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
||
| 393 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
||
| 394 | Total bilirubin within normal institutional limits |
||
| 395 | Cardiac function within institutional normal limits on echocardiogram |
||
| 396 | Serum potassium and magnesium levels within normal limits |
||
| 397 | Uric acid within normal limits |
||
| 398 | Total bilirubin within normal institutional limits |
||
| 399 | Total bilirubin within normal institutional limits |
||
| 400 | Serum creatinine within normal institutional limits |
||
| 401 | Potassium, magnesium, and calcium (corrected for albumin) > normal limits for the institution |
||
| 402 | Bilirubin within normal institutional limits within 14 days prior to registration |
||
| 403 | Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal. |
||
| 404 | Total bilirubin within normal limits |
||
| 405 | Total bilirubin within normal limits |
||
| 406 | Serum potassium, and magnesium within normal limits |
||
| 407 | Troponin I or T within normal limits |
||
| 408 | Total bilirubin within normal institutional limits |
||
| 409 | TREATMENT: Total bilirubin < 1.5 x upper limits of normal |
||
| 410 | Total bilirubin within normal institutional limits |
||
| 411 | Serum total bilirubin is less than or equal to the upper limits of normal |
||
| 412 | Total bilirubin within normal institutional limits |
||
| 413 | Total bilirubin within normal limits |
||
| 414 | Electrocardiogram (ECG) within normal limits |
||
| 415 | Performed within 10 days of treatment initiation: Thyroid stimulating hormone (TSH) within institutional limits (ie: normal); if TSH is greater or less than institutional limits patients may participate if their thyroxine (T4) is within normal limits (WNL); patients may be on a stable dose of replacement thyroid medication; dose adjustments are allowed if needed |
||
| 416 | Serum creatinine (Cr) within normal limits (WNL) or |
||
| 417 | Total bilirubin < 1.5 x within normal institutional limits (unless due to lymphoma involvement of liver or a known history of Gilbert’s disease) |
||
| 418 | Total bilirubin within normal institutional limits |
||
| 419 | Electrolytes within normal limits |
||
| 420 | Potassium and calcium (corrected for albumin), sodium and magnesium within institutional normal limits |
||
| 421 | Inorganic phosphorus outside of normal limits |
||
| 422 | Total and ionized serum calcium outside of normal limits |
||
| 423 | Coagulation: INR within normal limits, PTT within normal limits |
||
| 424 | Total bilirubin must be within 1.5 X the normal institutional limits; if total bilirubin is outside the normal institutional limits, assess direct bilirubin; the direct bilirubin must be within normal parameters |
||
| 425 | Total bilirubin within normal limits |
||
| 426 | Total Bilirubin ? 1.5 x upper limits of normal |
||
| 427 | AST (SGOT) ? 2.5 x upper limits of normal |
||
| 428 | ALT (SGPT) ? 2.5 x upper limits of normal |
||
| 429 | Total bilirubin within normal institutional limits |
||
| 430 | Magnesium within 0.85 to 1.25 * institutional normal limits, Sodium greater than or equal to 130 milli equivalent per liter, Potassium within institutional normal limits (within 14 days prior to Day 1 of Cycle 1 up until pre-dose of Cycle 1) |
||
| 431 | Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed) |
||
| 432 | Potassium within normal limits for the institution |
||
| 433 | Serum creatinine within normal limits |
||
| 434 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
||
| 435 | Total serum bilirubin within normal institutional limits |
||
| 436 | Total bilirubin within normal institutional limits |
||
| 437 | Total bilirubin =< 1.5 x institutional upper limits of normal |
||
| 438 | Total bilirubin within normal institutional limits |
||
| 439 | Creatinine up to 1.5 X normal institutional limits |
||
| 440 | Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed) |
||
| 441 | Total bilirubin within normal institutional limits |
||
| 442 | Serum magnesium must be within institutional normal limits |
||
| 443 | Serum potassium must be within institutional normal limits |
||
| 444 | Total bilirubin within normal institutional limits |
||
| 445 | Serum calcium, magnesium and potassium must be within normal limits; supplementation to achieve normal values is permitted |
||
| 446 | Total bilirubin within normal institutional limits |
||
| 447 | Creatinine within normal institutional limits OR |
||
| 448 | Amylase =< 2 × upper limits of normal |
||
| 449 | Lipase =< 2 × upper limits of normal |
||
| 450 | Hemoglobin within institutional normal limits |
||
| 451 | Platelet count within institutional normal limits |
||
| 452 | Absolute neutrophil count within institutional normal limits |
||
| 453 | Absolute lymphocyte count within institutional normal limits |
||
| 454 | Serum chemistries within institutional normal limits or requirements for radical prostatectomy |
||
| 455 | Renal panels within institutional normal limits or requirements for radical prostatectomy |
||
| 456 | Liver panels within institutional normal limits or requirements for radical prostatectomy |
||
| 457 | Total bilirubin < 1.5 x upper limits of normal |
||
| 458 | Total bilirubin =< 1.5 x upper limits of normal (ULN) |
||
| 459 | Potassium with institutional limits (supplementation allowed) |
||
| 460 | Magnesium within normal limits (supplementation allowed) |
||
| 461 | Total bilirubin within normal institutional limits |
||
| 462 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
||
| 463 | Total bilirubin within normal institutional limits |
||
| 464 | Creatinine within normal institutional limits for age |
||
| 465 | Total bilirubin within normal institutional limits |
||
| 466 | Creatinine =< 1.5 x upper limits of normal |
||
| 467 | Bilirubin =< 1.5 x upper limits of normal |
||
| 468 | Resting blood pressure and/or heart rate within normal limits |
||
| 469 | Resting blood pressure and/or heart rate outside normal limits |
||
| 470 | Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal |
||
| 471 | Total bilirubin =< 1.5 x the upper limits of normal (ULN) |
||
| 472 | Serum electrolytes within normal limits: potassium, calcium (total, or corrected for serum albumin in case of hypoalbuminemia) and magnesium. If outside of normal limits, subject will be eligible when electrolytes are corrected; |
||
| 473 | Creatinine within normal limits |
||
| 474 | Total bilirubin within normal institutional limits |
||
| 475 | Corrected calcium within normal limits, previous hypercalcemia allowed |
||
| 476 | Creatinine =< institutional upper limits of normal (ULN) |
||
| 477 | Urinary testing results within institutional limits of normal or deemed clinically insignificant |
||
| 478 | Platelets >= the lower institutional limits |
||
| 479 | Total bilirubin within normal institutional limits |
||
| 480 | Creatinine =< the upper institutional limits |
||
| 481 | Total bilirubin within normal institutional limits |
||
| 482 | Creatinine within normal institutional limits |
||
| 483 | Platelets within institutional limits of normal or judged to be not clinically significant by the investigator |
||
| 484 | Hemoglobin within institutional limits of normal or judged to be not clinically significant by the investigator |
||
| 485 | Total bilirubin within institutional limits of normal or judged to be not clinically significant by the investigator |
||
| 486 | Creatinine within institutional limits of normal or judged to be not clinically significant by the investigator |
||
| 487 | Serum creatinine < 1.5 x upper limits of normal, or |
||
| 488 | Total bilirubin < 1.5 x upper limits of normal |
||
| 489 | Serum creatinine =< 2.0 x upper limits of normal, or |
||
| 490 | Total bilirubin < 2.0 x upper limits of normal |
||
| 491 | Serum total bilirubin within normal institutional limits |
||
| 492 | Total bilirubin within normal institutional limits; higher values (=< 3 x institutional upper limit of normal [ULN]) are acceptable in participants with: 1. known or suspected cholangitis associated with Crohn’s disease, or 2, known or suspected inborn errors of metabolism that lead to increased bilirubin |
||
| 493 | Creatinine within normal institutional limits |
||
| 494 | Total bilirubin within normal institutional limits |
||
| 495 | Normal renal function (defined as creatinine within normal institutional limits) |
||
| 496 | Known chronic kidney disease with creatinine greater than normal institutional limits |
||
| 497 | Total bilirubin within normal institutional limits |
||
| 498 | Potassium within normal limits |
||
| 499 | Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication |
||
| 500 | Renal insufficiency (i.e., serum creatinine outside of normal limits) |
||
| 501 | Participants must have an echocardiogram within normal limits within the last year |
||
| 502 | Hematocrit within normal institutional limits |
||
| 503 | Platelets within normal institutional limits |
||
| 504 | Creatinine =< the upper institutional limits |
||
| 505 | Creatinine within institutional normal limits |
||
| 506 | Participants must have an ionized serum calcium within normal limits |
||
| 507 | Total bilirubin within normal institutional limits |
||
| 508 | Total bilirubin within normal institutional limits |
||
| 509 | Total bilirubin within normal institutional limits |
||
| 510 | Bilirubin > 2.0 x ULN (institutional upper limits of normal) |
||
| 511 | Total bilirubin within normal institutional limits |
||
| 512 | SURGICAL ARM: total bilirubin within normal institutional limits |
||
| 513 | Creatinine clearance within normal limits |
||
| 514 | Bilirubin > 2 x institutional upper limits of normal (ULN), with exception of patients with Gilberts disease |
||
| 515 | Total bilirubin within normal institutional limits |
||
| 516 | Creatinine within normal institutional limits |
||
| 517 | Bilirubin > 1.5 x ULN (institutional upper limits of normal) |
||
| 518 | Hepatic enzymes 5 times greater than the upper limits of normal |
||
| 519 | 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 |
||
| 520 | Bilirubin > 1.5 x institutional upper limits of normal (ULN) |
||
| 521 | Total bilirubin within normal institutional limits |
||
| 522 | Total bilirubin within normal institutional limits |
||
| 523 | Total bilirubin < 2 x normal institutional limits or > 3.0 mg/dl in patients with Gilbert’s syndrome |
||
| 524 | Total bilirubin within normal institutional limits |
||
| 525 | Creatinine within normal institutional limits |
||
| 526 | Total bilirubin within normal institutional limits |
||
| 527 | Total bilirubin within normal institutional limits |
||
| 528 | Bilirubin within normal limits |
||
| 529 | Total bilirubin within normal institutional limits |
||
| 530 | Total bilirubin within normal institutional limits |
||
| 531 | total bilirubin within normal institutional limits |
||
| 532 | serum creatinine w/in normal limits or |
||
| 533 | Patients must have the following electrolyte values within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication: |
||
| 534 | total bilirubin within normal institutional limits |
||
| 535 | total bilirubin within normal institutional limits (except in cases of malignant biliary obstruction) |