Back to resultsA Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Primary Purpose
Exocrine Pancreatic Insufficiency (EPI)
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pancrelipase
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Exocrine Pancreatic Insufficiency (EPI) focused on measuring Exocrine Pancreatic Insufficiency (EPI), Pancreatic Cancer, Creon, Pancrelipase
Eligibility Criteria
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.
Sites / Locations
- Alabama Oncology /ID# 207770
- Banner University of Arizona Medical Center Phoenix /ID# 208402
- UCSF Fresno /ID# 205757
- Stanford University School of Med /ID# 208821
- UCH-MHS Memorial Hospital Central /ID# 207093
- UCHealth Cancer Care and Hematology Clinic /ID# 207091
- George Washington University Medical Faculty Associates /ID# 203363
- University of Florida - Archer /ID# 202679
- Columbus Regional Research Institute /ID# 211394
- Northwest Community Hospital /ID# 202270
- NorthShore University HealthSystem /ID# 209026
- Ingalls Memorial Hosp /ID# 203962
- Advocate Christ Medical Center /ID# 203132
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 204407
- Ascension Providence Hospital /ID# 203449
- St. Louis University /ID# 205769
- Mercy Hospital South /ID# 221766
- Northwell Health Center for Liver Diseases /ID# 207321
- NYU Winthrop Hospital /ID# 207513
- New York University Langone Me /ID# 202290
- Columbia University Medical Center /ID# 204165
- East Carolina University /ID# 206661
- Gabrail Cancer Center Research /ID# 208030
- Ohio State Cancer Center /ID# 203131
- Fox Chase Cancer Center /ID# 202288
- Reading Hospital /ID# 206869
- Musc /Id# 210727
- Tennessee Cancer Specialists /ID# 208235
- Vanderbilt University Medical Center /ID# 204231
- Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 206156
- UT MD Anderson Cancer Center /ID# 202271
- Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 205746
- Medical College of Wisconsin /ID# 205714
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase
Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03859869
Brief Title
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Business Considerations (difficulty with enrollment)
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
March 23, 2022 (Actual)
Study Completion Date
March 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exocrine Pancreatic Insufficiency (EPI)
Keywords
Exocrine Pancreatic Insufficiency (EPI), Pancreatic Cancer, Creon, Pancrelipase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase
Arm Type
Experimental
Arm 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.
Arm Title
Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
Arm Type
Experimental
Arm 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.
Arm Title
Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Pancrelipase
Other Intervention Name(s)
Creon
Intervention Description
Pancrelipase is administered orally as capsules with a meal or snack
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is administered orally as capsules with a meal or snack
Primary Outcome Measure Information:
Title
Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
Description
Stool samples were collected during the 48 hours prior to the Day 1 and Week 1 visits and analyzed for fat content.
Time Frame
Baseline (Day 1), Week 1 (Day 8)
Secondary Outcome Measure Information:
Title
Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
Description
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.
Time Frame
Baseline (Day 1), Week 1 (Day 8)
Title
Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer
Description
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.
Time Frame
Baseline (Day 1), Week 1 (Day 8)
Title
Change in the Total EPI Symptoms Score From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer
Description
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.
Time Frame
Baseline (Day 1), Week 1 (Day 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Oncology /ID# 207770
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35223-2437
Country
United States
Facility Name
Banner University of Arizona Medical Center Phoenix /ID# 208402
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
UCSF Fresno /ID# 205757
City
Fresno
State/Province
California
ZIP/Postal Code
93701-2302
Country
United States
Facility Name
Stanford University School of Med /ID# 208821
City
Stanford
State/Province
California
ZIP/Postal Code
94305-2200
Country
United States
Facility Name
UCH-MHS Memorial Hospital Central /ID# 207093
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909-4533
Country
United States
Facility Name
UCHealth Cancer Care and Hematology Clinic /ID# 207091
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528-3400
Country
United States
Facility Name
George Washington University Medical Faculty Associates /ID# 203363
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037-3201
Country
United States
Facility Name
University of Florida - Archer /ID# 202679
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Columbus Regional Research Institute /ID# 211394
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-8915
Country
United States
Facility Name
Northwest Community Hospital /ID# 202270
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005-2355
Country
United States
Facility Name
NorthShore University HealthSystem /ID# 209026
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hosp /ID# 203962
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Advocate Christ Medical Center /ID# 203132
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453-2600
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 204407
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Ascension Providence Hospital /ID# 203449
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075-4825
Country
United States
Facility Name
St. Louis University /ID# 205769
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Mercy Hospital South /ID# 221766
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Northwell Health Center for Liver Diseases /ID# 207321
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030-3815
Country
United States
Facility Name
NYU Winthrop Hospital /ID# 207513
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
New York University Langone Me /ID# 202290
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center /ID# 204165
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Facility Name
East Carolina University /ID# 206661
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 208030
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Ohio State Cancer Center /ID# 203131
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Fox Chase Cancer Center /ID# 202288
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Reading Hospital /ID# 206869
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Musc /Id# 210727
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Tennessee Cancer Specialists /ID# 208235
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 204231
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 206156
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2003
Country
United States
Facility Name
UT MD Anderson Cancer Center /ID# 202271
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 205746
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical College of Wisconsin /ID# 205714
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
Related Info
Learn more about this trial
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
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