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.