--- a +++ b/clusters/3009knumclusters/clust_294.txt @@ -0,0 +1,200 @@ +Amylase and lipase =< 1.5 x ULN without any symptoms of pancreatitis +PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum lipase and amylase < 1.5 x ULN, within 2 weeks prior to enrollment +PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum lipase and amylase < 1.5 x ULN, within 2 weeks prior to enrollment +Serum lipase =< ULN at baseline; patients with glucose intolerance should be on a stable regimen and be monitored +Serum amylase =< 1.5 x ULN +Serum lipase =< 1.5 x ULN +Patients must have amylase or lipase within =< 1.5 x IULN without symptoms of pancreatitis at registration, within 28 days prior to registration +Serum amylase =< 1.5 ULN +Serum lipase =< 1.5 ULN +Lipase: 1.5 x ULN. Subjects with lipase >1.5 x ULN may enrol if there are neither clinical or radiographic signs of pancreatitis +Amylase: 1.5 x ULN. Subjects with amylase >1.5 x ULN may enrol if there are neither clinical or radiographic signs of pancreatitis +Serum pancreatic amylase < 1.5 x ULN +Serum pancreatic lipase < 1.5 x ULN +Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis, within 14 days before the first dose of cabozantinib +Serum lipase and amylase =< 1.5 x ULN +Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis within 7 days before the first dose of cabozantinib +Amylase/lipase =< 1.5 x institutional ULN (without symptoms of pancreatitis) +Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis +EXCLUSION - INFUSION: Lipase > 70 U/ml +Asymptomatic serum amylase =< grade 2 and asymptomatic serum lipase =< grade 2; patients with grade 1 or grade 2 serum amylase or lipase at the beginning of the study must be confirmed to have no signs and/or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.), at the screening visit +Asymptomatic serum amylase =< 2 x ULN; patients with > ULN but =< 2 x ULN serum amylase at study start must be confirmed to have no signs and/or symptoms suggestion pancreatitis or pancreatic injury (e.g. elevated pancreatic [P]-amylase, abnormal imaging findings of pancreas, etc.) +Serum lipase =< ULN +History of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease. +Amylase =< 1 x ULN. +Lipase =< 1 x ULN. +Amylase and lipase =< 2 x ULN +Serum amylase =< 1.5 X institutional ULN +Lipase =< 1.5 X institutional ULN +Obtained within 28 days prior to the first dose of cabozantinib: lipase =< 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis. +Amylase and lipase < 1.5 x ULN obtained ? 14 days prior to randomization +Lipase =< 2.0 x ULN and no radiologic or clinical evidence of pancreatitis +Amylase and lipase =< 1.5 ULN; subjects with amylase or lipase > 1.5 ULN may enroll if there are neither clinical nor radiographic signs of pancreatitis +Serum lipase and amylase =< 1.5 x ULN. +Serum lipase > 1.5 x ULN +Serum lipase and amylase =< 1.5 x ULN. +Lipase =< 1.5 x ULN +Serum amylase/lipase =< 1.5 x ULN +Serum amylase =< 2 x ULN +Serum lipase =< ULN +Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease +Lipase =< 3 x ULN +Serum amylase =< ULN +Lipase =< ULN +FULL STUDY INCLUSION CRITERIA: Amylase and lipase =< 1.5 x ULN +Lipase < 2 ULN +Note: in the absence of clinical symptoms of pancreatitis, elevations of amylase or lipase are not contraindications to therapy on this trial +Serum amylase and lipase =< 2 x ULN +Serum amylase and lipase =< 1.5 x ULN +Serum amylase and lipase =< 1.5 x institutional ULN +Normal serum lipase and amylase (per institutional normal values) +Serum amylase =< 2 x ULN +Serum lipase =< ULN +History of pancreatitis or history of increased amylase or lipase that was due to pancreatitis +Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis +CAPMATINIB INCLUSION CRITERIA: Serum amylase =< grade 2 and asymptomatic; patients with grade 1 or 2 serum amylase at the beginning of the study must be confirmed to have no signs and/or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.) +CAPMATINIB INCLUSION CRITERIA: Serum lipase =< ULN +CERITINIB INCLUSION CRITERIA: Serum lipase =< ULN +CERITINIB EXCLUSION CRITERIA: History of pancreatitis, or history of increased amylase or lipase that was due to pancreatic disease +Serum amylase =< 2 x ULN +Serum lipase =< ULN +Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease +Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis +Have normal pancreatic status as defined by the following criterion: a. Serum lipase and amylase ? 1.5 × ULN +Amylase =< 2 X ULN +For patients being screened for Group 2, asymptomatic serum amylase > CTCAE Grade 2 (1.5-2.0 x ULN). Patients with Grade 1 or Grade 2 serum amylase at the beginning of the study must be confirmed to have no signs or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.) +For patients being screened for Group 2: Serum lipase > ULN +Lipase <=1.5*ULN and amylase <=1.5*ULN with no clinical symptoms suggestive of pancreatitis or cholecystitis. +Within 4 days prior to the first dose of cabozantinib: Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis +Serum amylase =< 2 x ULN +Serum lipase =< ULN +Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease +Serum lipase and amylase =< 1.5 x ULN +Serum lipase =< 2 x ULN +Serum amylase =< 2 x ULN +Lipase < 2.0 x ULN; no radiologic or clinical evidence of pancreatitis +Serum amylase =< ULN +Serum lipase =< ULN +Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis +Serum lipase and amylase =< 1.5 x ULN +Asymptomatic serum amylase grade > 2 (1.5-2.0 x ULN). Patients with grade 1 or grade 2 serum amylase at the beginning of the study must be confirmed to have no signs or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.) +Serum lipase > ULN +Serum amylase =< ULN +Serum lipase =< ULN +Within 14 days prior to first dose of study drug treatment: Amylase and lipase =< 1.5 x ULN +Within 7 days before the first dose of cabozantinib: Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis +Amylase < ULN +Lipase < ULN +Serum amylase and lipase within normal limits +Lipase =< 1.5 x the ULN +Amylase =< 1.5 x the ULN +Within 14 days prior to registration: Serum amylase =< 1.5 x institution’s ULN +Within 14 days prior to registration: Serum lipase =< 1.5 x institution’s ULN +Amylase and/or lipase =< 1.5 x ULN, obtained =< 7 days prior to registration +Lipase < 2.0 x ULN; no radiologic/clinical evidence of pancreatitis +Lipase > 1.5 ULN; participants with lipase > 1.5 ULN may enroll if there are neither clinical nor radiographic signs of a pancreatitis +Amylase > 1.5 ULN; participants with amylase > 1.5 ULN may enroll if there are neither clinical nor radiographic signs of a pancreatitis +Lipase < 1.5 times the ULN +Fasting serum amylase =< 2 x institutional ULN +Fasting serum lipase =< institutional ULN +Patients must have a lipase and amylase performed within 7 days prior to sub-study registration +Serum amylase and lipase =< 1.5 x the ULN +Amylase =< 1.5 x ULN +Lipase =< 1.5 x ULN +Within 14 days of subject registration: Serum amylase =< 2 x ULN and serum lipase within normal limits +Amylase or lipase within normal limit (per institutional standards) +Lipase =< 1.5 x upper limit of normal (ULN) +Amylase (0-160 U/L) and lipase (0-130 U/L) levels within 1.5 times the range of normal +Serum amylase =< ULN +Serum lipase =< ULN +Amylase and lipase =< 1.5 x the upper limit of normal +Patients must have a lipase, amylase, TSH with reflex free T3/T4 performed within 7 days prior to sub-study registration; (Note: For the Canadian sites, testing for lipase only is acceptable) +Amylase and lipase <=ULN [Applies to Phase 2]. +Lipase < 2 X the upper limit of normal (ULN) and no radiologic or clinical evidence of pancreatitis +Lipase performed within 28 days of randomization must be less than or equal to 1.5 x ULN for the lab. +Lipase =< 1.5 x the ULN +Serum amylase =< ULN +Serum lipase =< ULN +Amylase and lipase ? 2X upper limit of normal +Lipase ? 1.5 x ULN +Asymptomatic serum amylase or lipase > Grade 2 +Serum amylase or serum lipase CTCAE grade ? 1 with signs and/or symptoms suggesting pancreatitis or pancreatic injury (e.g. elevated P-amylase, abnormal imaging findings of pancreas, etc) +Adequate pancreatic function, defined as amylase and lipase less than or equal to 1.5 X ULN +Amylase and lipase =< 2 times institutional ULN for age +Obtained =< 7 days prior to registration:\r\nSerum amylase and lipase =< 1.5 x upper limit of normal (ULN) +Lipase =< 1.5 x the ULN +Lipase less than or equal to 2 x ULN +Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease. +Serum lipase and amylase =< 2.5 x ULN; NOTE: if subject has tumor involvement in the liver =< 3 x ULN +Lipase =< 1.5 x the ULN +Serum amylase =< ULN +Serum lipase =< ULN +Lipase =< 1.5 x the ULN +Amylase =< 1.5 x the ULN +Serum lipase/amylase ?1.5 x ULN +Lipase =< 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis +Serum amylase > 1.5 x ULN or serum lipase > 1.5 x ULN. +Amylase and lipase equal to, or less than, the institutional ULN +PART B: Serum lipase =< 1.5 X ULN +PART B: Serum amylase =< 1.5 X ULN +Normal serum amylase =< (ULN) OR normal +Serum lipase =< ULN +Obtained =< 7 days prior to registration: Serum lipase =< 1.5 x ULN +Serum lipase ? 2 x ULN +Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis +Serum amylase =< 1.5 x ULN +Serum lipase =< 1.5 x ULN +Have Amylase =< 2.5x ULN +Amylase and lipase levels =< ULN +Amylase and lipase =< 1.5 x ULN +Amylase < 1.5 times ULN +Amylase and lipase < 1.5 x of ULN +Serum amylase or lipase <1.5 x ULN; +Amylase and lipase =< 2 x ULN +Amylase and lipase ? 2.5 x ULN (? 5 x ULN for subjects with pancreas involvement with tumor) +Lipase levels < 1.5 X ULN +Amylase levels < 1.5 X ULN +Serum amylase =< ULN +Serum lipase =< ULN +Amylase =< 1.5 x the ULN +Lipase =< 1.5 x the ULN +Serum lipase ? 3 x ULN and serum amylase within the normal range +Serum lipase ? 3 x ULN and serum amylase within the normal range +Lipase and amylase =< 1.5 x ULN +Lipase</=1.5 times the ULN +Serum lipase > normal limits for the institution +Asymptomatic serum amylase > grade 2 +Lipase =< 1.5 x ULN +Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis +Serum amylase =< 2 x ULN +Serum lipase =< 1 x ULN +History of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease +Lipase and amylase =< 2.0 x ULN and no radiologic or clinical evidence of pancreatitis +Serum amylase =< upper limit of normal (ULN) (if > ULN, confirm pancreatic amylase < 1 .1ukat/L and serum lipase < ULN) +Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis +Serum amylase and lipase within normal limits +Amylase =< 1.5 x ULN +Lipase =< 1.5 x ULN +Amylase and lipase ? 1.5 x ULN +History of pancreatitis, or amylase > ULN +History of lipase > ULN +Serum amylase =< ULN +Serum lipase =< ULN +Amylase and Lipase < 1.5 x normal for age. +Lipase =< 1.5 x the ULN +Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis +>= grade 2 lipase increased (> 1.5 x ULN) +Any history of an immune-related Grade 4 adverse event attributed to prior CIT (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase) +Patients with a prior or current history of a second malignancy, impaired GI function, history of pancreatitis or increased amylase or lipase, known diagnosis of HIV, and clinically significant cardiac disease were excluded. +Amylase =< 1.5 x ULN +Lipase =< 1.5 x ULN +Serum amylase =< 2 x ULN +Serum lipase =< ULN +Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease +Lipase =< 1.5 x the ULN +Lipase =< 1.5 ULN +Lipase <=1.5*ULN and amylase <=1.5*ULN with no clinical symptoms suggestive of pancreatitis or cholecystitis. +Lipase ?1.5×ULN and amylase ?1.5×ULN with no clinical symptoms suggestive of pancreatitis or cholecystitis. +At least two episodes of acute pancreatitis in the past 12 months; acute pancreatitis is defined any 2 of the following: (1) typical upper abdominal pain; (2) elevation in serum amylase or lipase >= 3 times upper limit of normal; (3) features of acute pancreatitis on cross-sectional imaging +Serum lipase =< 1.5 x ULN +Lipase must be <=1.5*ULN and amylase <=1.5*ULN with no clinical symptoms suggestive of pancreatitis and cholecystitis.