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

Creon (Pancrelipase) Therapy for Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Pancreatic Cancer: A Double-blind, Randomized, Parallel Design With 2 Dose Cohorts of Pancrelipase in Resected Pancreatic Cancer Subjects and an Open-label Single Dose Cohort in Non-resected Pancreatic Cancer Subjects

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.

Study Overview

• Status: Terminated
• Conditions: Exocrine Pancreatic Insufficiency (EPI)
• Intervention / Treatment: Drug: Pancrelipase; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35223-2437
      • Alabama Oncology /ID# 207770
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University of Arizona Medical Center Phoenix /ID# 208402
  • California
    • Fresno, California, United States, 93701-2302
      • UCSF Fresno /ID# 205757
    • Stanford, California, United States, 94305-2200
      • Stanford University School of Med /ID# 208821
  • Colorado
    • Colorado Springs, Colorado, United States, 80909-4533
      • UCH-MHS Memorial Hospital Central /ID# 207093
    • Fort Collins, Colorado, United States, 80528-3400
      • UCHealth Cancer Care and Hematology Clinic /ID# 207091
  • District of Columbia
    • Washington, District of Columbia, United States, 20037-3201
      • George Washington University Medical Faculty Associates /ID# 203363
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida - Archer /ID# 202679
  • Georgia
    • Columbus, Georgia, United States, 31904-8915
      • Columbus Regional Research Institute /ID# 211394
  • Illinois
    • Arlington Heights, Illinois, United States, 60005-2355
      • Northwest Community Hospital /ID# 202270
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem /ID# 209026
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hosp /ID# 203962
    • Oak Lawn, Illinois, United States, 60453-2600
      • Advocate Christ Medical Center /ID# 203132
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 204407
    • Southfield, Michigan, United States, 48075-4825
      • Ascension Providence Hospital /ID# 203449
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • St. Louis University /ID# 205769
    • Saint Louis, Missouri, United States, 63128
      • Mercy Hospital South /ID# 221766
  • New York
    • Manhasset, New York, United States, 11030-3815
      • Northwell Health Center for Liver Diseases /ID# 207321
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital /ID# 207513
    • New York, New York, United States, 10016
      • New York University Langone Me /ID# 202290
    • New York, New York, United States, 10032-3729
      • Columbia University Medical Center /ID# 204165
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • East Carolina University /ID# 206661
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research /ID# 208030
    • Columbus, Ohio, United States, 43210
      • Ohio State Cancer Center /ID# 203131
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center /ID# 202288
    • Reading, Pennsylvania, United States, 19611
      • Reading Hospital /ID# 206869
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Musc /Id# 210727
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Tennessee Cancer Specialists /ID# 208235
    • Nashville, Tennessee, United States, 37232-0011
      • Vanderbilt University Medical Center /ID# 204231
  • Texas
    • Dallas, Texas, United States, 75246-2003
      • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 206156
    • Houston, Texas, United States, 77030
      • UT MD Anderson Cancer Center /ID# 202271
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 205746
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Medical College of Wisconsin /ID# 205714

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase; 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.	Drug: Pancrelipase; Pancrelipase is administered orally as capsules with a meal or snack; Other Names: Creon; Drug: Placebo; Placebo is administered orally as capsules with a meal or snack
Experimental: Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase; 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.	Drug: Pancrelipase; Pancrelipase is administered orally as capsules with a meal or snack; Other Names: Creon; Drug: Placebo; Placebo is administered orally as capsules with a meal or snack
Experimental: Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase; 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.	Drug: Pancrelipase; Pancrelipase is administered orally as capsules with a meal or snack; Other Names: Creon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer	Stool samples were collected during the 48 hours prior to the Day 1 and Week 1 visits and analyzed for fat content.	Baseline (Day 1), Week 1 (Day 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer	Participants recorded stool frequency using an electronic diary (eDiary). The average daily stool frequency was calculated from the last 3 days prior to the Baseline and Week 1 visits.	Baseline (Day 1), Week 1 (Day 8)
Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer	Participants recorded stool consistency using an electronic diary (eDiary). The change from Baseline to Week 1 is the proportion of days having watery stool consistency in the last 7 days prior to each of Baseline and Week 1 visits. Negative changes from Baseline indicate less frequent watery stools.	Baseline (Day 1), Week 1 (Day 8)
Change in the Total EPI Symptoms Score From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer	The EPI Symptoms Questionnaire consists of 12 questions. The response scores range from 0 to 4 for each question (0 corresponding to None to 4 corresponding to Very Severe), with the total score ranging from 0 to 48. Positive changes indicate worsening from Baseline.	Baseline (Day 1), Week 1 (Day 8)

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Actual): March 23, 2022
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Pancrelipase; Creon; Exocrine Pancreatic Insufficiency (EPI)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Exocrine Pancreatic Insufficiency; Gastrointestinal Agents; Pancrelipase; Pancreatin
• Other Study ID Numbers: M16-142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link: https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No