Exocrine Pancreatic Insufficiency (EPI)Phase 4NCT03859869

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

A Phase 4 study testing Pancrelipase in people with Exocrine Pancreatic Insufficiency (EPI), run by AbbVie at 33 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Exocrine Pancreatic Insufficiency (EPI)
What is being tested?: Pancrelipase
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1 participants
Where: 33 sitesUnited States
Study dates: 25 Feb 2020to 23 Mar 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

33 sites in 1 country.

City, postcode or hospital

33 sites in 1 country

United States33 sites

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

Other trials in United States

About this study

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

Conditions: Exocrine Pancreatic Insufficiency (EPI)
Being tested: Pancrelipase, Placebo
Keywords: Exocrine Pancreatic Insufficiency (EPI), Pancreatic Cancer, Creon, Pancrelipase
Medical subject headings: Exocrine Pancreatic Insufficiency, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PancrelipaseDrug
Also called Creon
Pancrelipase is administered orally as capsules with a meal or snack
PlaceboDrug
Placebo is administered orally as capsules with a meal or snack

Study groups in NCT03859869
Study group	Role	What they receive
Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase	Experimental	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. Receives: Drug: Pancrelipase; Drug: Placebo
Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase	Experimental	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. Receives: Drug: Pancrelipase; Drug: Placebo
Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase	Experimental	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. Receives: Drug: Pancrelipase

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1), Week 1 (Day 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 202023 Mar 2022

First posted1 Mar 2019
Study start25 Feb 2020
Primary completion23 Mar 2022
Study completion23 Mar 2022

Why it stopped: Business Considerations (difficulty with enrollment)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Exocrine Pancreatic Insufficiency (EPI)Studies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03859869
Sponsor's protocol ID: M16-142
Status last verified: Jun 2023
First submitted: 28 Feb 2019
Last updated: 5 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Exocrine Pancreatic Insufficiency (EPI) trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03859869
Acronym / sponsor ID: M16-142
Conditions: Exocrine Pancreatic Insufficiency (EPI)
Keywords: Exocrine Pancreatic Insufficiency (EPI), Pancreatic Cancer, Creon, Pancrelipase
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business Considerations (difficulty with enrollment)
Enrolment: 1 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 25 Feb 2020 (actual)
Primary completion: 23 Mar 2022 (actual)
Study completion: 23 Mar 2022 (actual)
First posted: 1 Mar 2019 (actual)
Results: Posted 5 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase	Experimental	Drug: Pancrelipase, Drug: PlaceboResected 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	Experimental	Drug: Pancrelipase, Drug: PlaceboResected 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	Experimental	Drug: PancrelipaseNon-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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PancrelipaseAlso: CreonPancrelipase is administered orally as capsules with a meal or snack	Drug	Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase, Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase, Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase
PlaceboPlacebo is administered orally as capsules with a meal or snack	Drug	Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase, Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase

Primary outcome

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

3 secondary outcomes

Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
Time frame: Baseline (Day 1), Week 1 (Day 8)
Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer
Time frame: 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
Time frame: Baseline (Day 1), Week 1 (Day 8)

Results and safety

Results posted to the registry on 5 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase	0	0
Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase	1	1
Non-Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase	0	0

Primary outcome: Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer

Time frame: Baseline (Day 1), Week 1 (Day 8). Mean (Standard Deviation). Unit: g/24 hours

Measure	Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase n = 0	Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase n = 1
Value	–	3.1

Population analysed: Participants who received at least one dose of study drug and who had evaluable stool fat at both Baseline and Week 1 visits

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase	0 of 0	0 of 0	0
Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Non-Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): This study was terminated due to low enrollment rates. The decision to terminate the study was not based on any safety or efficacy data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Exocrine Pancreatic Insufficiency (EPI)

RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ABBVIE INC. study director

AbbVie

33 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pancrelipase in people with Exocrine Pancreatic Insufficiency (EPI), run by AbbVie at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer (time frame: Baseline (Day 1), Week 1 (Day 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.