Clinical trial NCT03859869: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Exocrine Pancreatic Insufficiency (EPI)
Keywords: Exocrine Pancreatic Insufficiency (EPI)
Pancreatic Cancer
Creon
Pancrelipase
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-03-01
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
timeFrame: Baseline (Day 1), Week 1 (Day 8)
Secondary outcomes:
measure: Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
timeFrame: Baseline (Day 1), Week 1 (Day 8)
measure: Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer
timeFrame: Baseline (Day 1), Week 1 (Day 8)
measure: Change in the Total EPI Symptoms Score From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer
timeFrame: Baseline (Day 1), Week 1 (Day 8)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology /ID# 207770
state: Alabama
city: Phoenix
country: United States
facility: Banner University of Arizona Medical Center Phoenix /ID# 208402
state: Arizona
city: Fresno
country: United States
facility: UCSF Fresno /ID# 205757
state: California
city: Stanford
country: United States
facility: Stanford University School of Med /ID# 208821
state: California
city: Colorado Springs
country: United States
facility: UCH-MHS Memorial Hospital Central /ID# 207093
state: Colorado
city: Fort Collins
country: United States
facility: UCHealth Cancer Care and Hematology Clinic /ID# 207091
state: Colorado
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates /ID# 203363
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida - Archer /ID# 202679
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute /ID# 211394
state: Georgia
city: Arlington Heights
country: United States
facility: Northwest Community Hospital /ID# 202270
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem /ID# 209026
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hosp /ID# 203962
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center /ID# 203132
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 204407
state: Michigan
city: Southfield
country: United States
facility: Ascension Providence Hospital /ID# 203449
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis University /ID# 205769
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital South /ID# 221766
state: Missouri
city: Manhasset
country: United States
facility: Northwell Health Center for Liver Diseases /ID# 207321
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital /ID# 207513
state: New York
city: New York
country: United States
facility: New York University Langone Me /ID# 202290
state: New York
city: New York
country: United States
facility: Columbia University Medical Center /ID# 204165
state: New York
city: Greenville
country: United States
facility: East Carolina University /ID# 206661
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research /ID# 208030
state: Ohio
city: Columbus
country: United States
facility: Ohio State Cancer Center /ID# 203131
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center /ID# 202288
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital /ID# 206869
state: Pennsylvania
city: Charleston
country: United States
facility: Musc /Id# 210727
state: South Carolina
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists /ID# 208235
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center /ID# 204231
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 206156
state: Texas
city: Houston
country: United States
facility: UT MD Anderson Cancer Center /ID# 202271
state: Texas
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 205746
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin /ID# 205714
state: Wisconsin
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: