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

AbbVie

Status and phase: Terminated; Phase 4

Conditions: Exocrine Pancreatic Insufficiency (EPI)

Treatments: Drug: Placebo; Drug: Pancrelipase

Study type: Interventional

Funder types: Industry

Identifiers

NCT03859869

M16-142

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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 exocrine pancreatic insufficiency (EPI) as evidenced by fecal elastase-1 (FE-1) ≤ 150 µg/g 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 3 patient groups

Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase

Experimental group

Description:

Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.

Treatment:

Drug: Placebo

Drug: Pancrelipase

Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase

Experimental group

Description:

Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.

Treatment:

Drug: Placebo

Drug: Pancrelipase

Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase

Experimental group

Description:

Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.

Treatment:

Drug: Pancrelipase