Phase
Condition
Pancreatic Cancer
Carcinoma
Metastatic Cancer
Treatment
Glipizide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Cohort 1
Age ≥18 years
Biopsy-proven PDAC
Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)
Willing and able to comply with the requirements of the protocol
Willing to use their bluetooth-enabled wifi or cellular mobile device
Hemoglobin A1c (HbA1c) >8%, or fructosamine >325 mg/dL, or random glucose >200 mg/dL, or strong clinical suspicion that patient has hyperglycemia, makingit reasonable to expect their mean daily glucose is ≥183 mg/dL
Eastern Cooperative Oncology Group performance status ≤2
BMI <30 kg/m2
Cohort 2a
Age ≥18 years
Biopsy-proven PDAC
Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic pancreatic cancer)
Clinical diagnosis of diabetes mellitus
Active care at MSK (defined as at least 1 physician or APP encounter every 3 months)for PDAC during the period from which data were recorded in the electronic medicalrecord (in this retrospective study patients need not be under active care at thetime the research is conducted)
At least 1 electronic prescription for a sulfonylurea (glipizide, glimepiride, orglyburide) or metformin
Three-month baseline period before metformin or sulfonylurea initiation in which theparticipant does not receive either drug class or insulin
Body weight recorded within 3 months before start of metformin or a sulfonylurea
Cohort 2b
Age ≥18 years
Biopsy-proven PDAC
Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)
Active care at MSK (defined as at least 1 physician or APP encounter every 3 months)for PDAC during the period of data collection
Apparent current use based on chart review of metformin (but not sulfonylurea);sulfonylurea (but not metformin); or neither drug
Exclusion
Exclusion Criteria:
Cohort 1
Use during the past month of any antidiabetic medication other than metformin athome (sporadic use [fewer than 1 of 7 days during the past month] is permitted)
Changes in metformin dose in the past month
History of sulfonylurea intolerance or allergy
History of severe hypoglycemia (hypoglycemia requiring emergency medical assistance,emergency room or urgent care visit, or hospital admission)
AST or ALT >3 x upper limit of normal
Glomerular filtration rate <30 mL/min/1.73m2
Daily chronic use of any dose of corticosteroids (as distinct from intermittentexposure to steroids as part of cyclic chemotherapy)
Inability to wear CGM
Cohort 2a
- Greater than trace ascites documented on imaging or physical exam
Cohort 2b
- Greater than trace ascites documented on imaging or physical exam
Study Design
Connect with a study center
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553
United StatesActive - Recruiting
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