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

Exocrine Pancreatic Insufficiency (EPI) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03859869
• Other study ID #: M16-142
• Status: Terminated
• Phase: Phase 4
• Start date: February 25, 2020
• Est. completion date: March 23, 2022

Study information

• Verified date: June 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Exocrine Pancreatic Insufficiency (EPI)
• Pancreatic Neoplasms

Intervention

Drug:
• Pancrelipase
Pancrelipase is administered orally as capsules with a meal or snack
• Placebo
Placebo is administered orally as capsules with a meal or snack

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 204407	Ann Arbor	Michigan
United States	Northwest Community Hospital /ID# 202270	Arlington Heights	Illinois
United States	Alabama Oncology /ID# 207770	Birmingham	Alabama
United States	Gabrail Cancer Center Research /ID# 208030	Canton	Ohio
United States	Musc /Id# 210727	Charleston	South Carolina
United States	UCH-MHS Memorial Hospital Central /ID# 207093	Colorado Springs	Colorado
United States	Columbus Regional Research Institute /ID# 211394	Columbus	Georgia
United States	Ohio State Cancer Center /ID# 203131	Columbus	Ohio
United States	Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 206156	Dallas	Texas
United States	NorthShore University HealthSystem /ID# 209026	Evanston	Illinois
United States	UCHealth Cancer Care and Hematology Clinic /ID# 207091	Fort Collins	Colorado
United States	UCSF Fresno /ID# 205757	Fresno	California
United States	University of Florida - Archer /ID# 202679	Gainesville	Florida
United States	East Carolina University /ID# 206661	Greenville	North Carolina
United States	Ingalls Memorial Hosp /ID# 203962	Harvey	Illinois
United States	UT MD Anderson Cancer Center /ID# 202271	Houston	Texas
United States	Tennessee Cancer Specialists /ID# 208235	Knoxville	Tennessee
United States	Northwell Health Center for Liver Diseases /ID# 207321	Manhasset	New York
United States	Medical College of Wisconsin /ID# 205714	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 205746	Milwaukee	Wisconsin
United States	NYU Winthrop Hospital /ID# 207513	Mineola	New York
United States	Vanderbilt University Medical Center /ID# 204231	Nashville	Tennessee
United States	Columbia University Medical Center /ID# 204165	New York	New York
United States	New York University Langone Me /ID# 202290	New York	New York
United States	Advocate Christ Medical Center /ID# 203132	Oak Lawn	Illinois
United States	Fox Chase Cancer Center /ID# 202288	Philadelphia	Pennsylvania
United States	Banner University of Arizona Medical Center Phoenix /ID# 208402	Phoenix	Arizona
United States	Reading Hospital /ID# 206869	Reading	Pennsylvania
United States	Mercy Hospital South /ID# 221766	Saint Louis	Missouri
United States	St. Louis University /ID# 205769	Saint Louis	Missouri
United States	Ascension Providence Hospital /ID# 203449	Southfield	Michigan
United States	Stanford University School of Med /ID# 208821	Stanford	California
United States	George Washington University Medical Faculty Associates /ID# 203363	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)

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