Trial Search Results

A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)

This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer that has been resected. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected participants.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

AbbVie

Stanford Investigator(s):

Intervention(s):

  • Drug: Pancrelipase
  • Drug: Placebo

Phase:

Phase 4

Eligibility


Inclusion Criteria:

   - Participant has diagnosed cancer of pancreas with biopsy and/or radiography, with a
   life expectancy of at least 5 months at screening.

   - Participant's pancreatic cancer must involve the head and/or neck of the pancreas.

   - Confirmed EPI as evidenced by fecal elastase-1 (FE-1) <= 150 microgram/gram stool at
   screening.

   - A positive Sudan stain for participants without history of fat malabsorption (fat
   malabsorption is defined as clinical steatorrhea, or measured stool fat > 7 g/day, or
   positive stool results by Sudan stain) within 1 week of screening.

      - Positive stool results are defined as increased level of neutral OR total fats.

Exclusion Criteria:

   - Participant has neuroendocrine pancreatic cancer.

   - Participant has fibrosing colonopathy

   - Participant has any other malignancy within 1 year of screening.

   - Participant has uncontrolled gout, including those with a recent flare within 60 days
   of screening.

   - Participant has other significant organ or bone marrow abnormality within 60 days of
   screening.

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Jacobs
1 650-721-3541
Recruiting