Study Stopped
Business Considerations (difficulty with enrollment)
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
1 other identifier
interventional
1
1 country
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2020
Typical duration for phase_4
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2022
CompletedResults Posted
Study results publicly available
June 5, 2023
CompletedJune 5, 2023
June 1, 2023
2.1 years
February 28, 2019
March 17, 2023
June 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
Baseline (Day 1), Week 1 (Day 8)
Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer
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
Baseline (Day 1), Week 1 (Day 8)
Study Arms (3)
Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase
EXPERIMENTALResected 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.
Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
EXPERIMENTALResected 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.
Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
EXPERIMENTALNon-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.
Interventions
Pancrelipase is administered orally as capsules with a meal or snack
Placebo is administered orally as capsules with a meal or snack
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (33)
Alabama Oncology /ID# 207770
Birmingham, Alabama, 35223-2437, United States
Banner University of Arizona Medical Center Phoenix /ID# 208402
Phoenix, Arizona, 85006, United States
UCSF Fresno /ID# 205757
Fresno, California, 93701-2302, United States
Stanford University School of Med /ID# 208821
Stanford, California, 94305-2200, United States
UCH-MHS Memorial Hospital Central /ID# 207093
Colorado Springs, Colorado, 80909-4533, United States
UCHealth Cancer Care and Hematology Clinic /ID# 207091
Fort Collins, Colorado, 80528-3400, United States
George Washington University Medical Faculty Associates /ID# 203363
Washington D.C., District of Columbia, 20037-3201, United States
University of Florida - Archer /ID# 202679
Gainesville, Florida, 32610, United States
Columbus Regional Research Institute /ID# 211394
Columbus, Georgia, 31904-8915, United States
Northwest Community Hospital /ID# 202270
Arlington Heights, Illinois, 60005-2355, United States
NorthShore University HealthSystem /ID# 209026
Evanston, Illinois, 60201, United States
Ingalls Memorial Hosp /ID# 203962
Harvey, Illinois, 60426, United States
Advocate Christ Medical Center /ID# 203132
Oak Lawn, Illinois, 60453-2600, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 204407
Ann Arbor, Michigan, 48109, United States
Ascension Providence Hospital /ID# 203449
Southfield, Michigan, 48075-4825, United States
St. Louis University /ID# 205769
St Louis, Missouri, 63104, United States
Mercy Hospital South /ID# 221766
St Louis, Missouri, 63128, United States
Northwell Health Center for Liver Diseases /ID# 207321
Manhasset, New York, 11030-3815, United States
NYU Winthrop Hospital /ID# 207513
Mineola, New York, 11501, United States
New York University Langone Me /ID# 202290
New York, New York, 10016, United States
Columbia University Medical Center /ID# 204165
New York, New York, 10032-3729, United States
East Carolina University /ID# 206661
Greenville, North Carolina, 27858, United States
Gabrail Cancer Center Research /ID# 208030
Canton, Ohio, 44718, United States
Ohio State Cancer Center /ID# 203131
Columbus, Ohio, 43210, United States
Fox Chase Cancer Center /ID# 202288
Philadelphia, Pennsylvania, 19111, United States
Reading Hospital /ID# 206869
Reading, Pennsylvania, 19611, United States
Musc /Id# 210727
Charleston, South Carolina, 29425, United States
Tennessee Cancer Specialists /ID# 208235
Knoxville, Tennessee, 37909, United States
Vanderbilt University Medical Center /ID# 204231
Nashville, Tennessee, 37232-0011, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 206156
Dallas, Texas, 75246-2003, United States
UT MD Anderson Cancer Center /ID# 202271
Houston, Texas, 77030, United States
Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 205746
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin /ID# 205714
Milwaukee, Wisconsin, 53226-3522, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated due to low enrollment rates. The decision to terminate the study was not based on any safety or efficacy data.
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2019
First Posted
March 1, 2019
Study Start
February 25, 2020
Primary Completion
March 23, 2022
Study Completion
March 23, 2022
Last Updated
June 5, 2023
Results First Posted
June 5, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.