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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859869
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE February 28, 2019
First Posted Date  ICMJE March 1, 2019
Last Update Posted Date April 21, 2021
Actual Study Start Date  ICMJE February 25, 2020
Estimated Primary Completion Date June 24, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
Change in stool for Resected Dose A and Resected Dose B [ Time Frame: From Baseline (Day 1) to Week 1 (Day 8) ]
Change in stool fat for Resected Dose A and Resected Dose B. Stool fat change is assessed using a paired t-test.
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
  • Change in stool fat [ Time Frame: From Baseline (Day 1) to Week 1 (Day 8) ]
    Stool fat change is assessed using a paired t-test
  • Adverse Events (AEs) [ Time Frame: Up to Week 17 ]
    Adverse events are any unfavorable and unintended sign, symptom, or disease temporally associated with use of a medicinal product
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
  • Difference between Resected Dose A and Resected Dose B in change from baseline in stool fat [ Time Frame: From Baseline (Day 1) to Week 1 ]
    Change from baseline in stool fat will be analyzed using an analysis of covariance model.
  • Stool frequency from baseline for Resected Dose A and Resected Dose B [ Time Frame: From Baseline (Day 1) to Week 5, Week 9, and Week 13 ]
    Stool frequency is a patient reported outcome recorded using an electronic diary (eDiary).
  • Difference between Resected Dose A and Resected Dose B in change from baseline in stool frequency [ Time Frame: From Baseline (Day 1) to Week 1 ]
    Difference between Resected Dose A and Resected Dose B in change in stool frequency.
  • Stool consistency from baseline for Resected Dose A and Resected Dose B [ Time Frame: From Baseline (Day 1) to Week 5, Week 9, and Week 13 ]
    Stool consistency is a patient reported outcome recorded using an electronic diary (eDiary).
  • Difference between Resected Dose A and Resected Dose B in change from baseline in stool consistency [ Time Frame: From Baseline (Day 1) to Week 1 ]
    Difference between Resected Dose A and Resected Dose B in change in stool consistency.
  • Exocrine pancreatic insufficiency (EPI) symptoms from baseline for Resected Dose A and Resected Dose B [ Time Frame: From Baseline (Day 1) to Week 5, Week 9, and Week 13 ]
    EPI symptoms are patient reported outcomes recorded using an electronic diary (eDiary).
  • Difference between Resected Dose A and Resected Dose B in change from baseline in EPI symptoms [ Time Frame: From Baseline (Day 1) to Week 1 ]
    Difference between Resected Dose A and Resected Dose B in change in EPI symptoms.
  • European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) questionnaire from baseline for Resected Dose A and Resected Dose B [ Time Frame: From Baseline (Day 1) to Week 5, Week 9, and Week 13 ]
    Change in EORTC QOL questionnaire for Resected Dose A and Resected Dose B.
  • Difference between Resected Dose A and Resected Dose B in change in EORTC QOL questionnaire [ Time Frame: From Baseline (Day 1) to Week 1 ]
    Difference between Resected Dose A and Resected Dose B in change in EORTC QOL questionnaire.
  • Body weight from baseline for Resected Dose A and Resected Dose B [ Time Frame: From Baseline (Day 1) to Week 5, Week 9, and Week 13 ]
    Change body weight for Resected Dose A and Resected Dose B.
  • Body mass index (BMI) from baseline for Resected Dose A and Resected Dose B [ Time Frame: From Baseline (Day 1) to Week 5, Week 9, and Week 13 ]
    Change in body mass index (BMI) for Resected Dose A and Resected Dose B.
  • Chemotherapy tolerability [ Time Frame: From Baseline (Day 1) up to Week 13 ]
    Chemotherapy tolerability will be evaluated through adverse events monitoring, physical examination, vital sign measurements, and laboratory testing.
  • Serum albumin from baseline for Resected Dose A and Resected Dose B [ Time Frame: From Baseline (Day 1) to Week 5, Week 9, and Week 13 ]
    Change in serum albumin for Resected Dose A and Resected Dose B. Low albumin levels can indicate a problem with your liver or kidneys.
  • Serum pre-albumin from baseline for Resected Dose A and Resected Dose B [ Time Frame: From Baseline (Day 1) to Week 5, Week 9, and Week 13 ]
    Change in serum pre-albumin for Resected Dose A and Resected Dose B. If pre-albumin levels are lower than normal, it may be a sign of poor nutrition.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
  • Difference between 2 dose cohorts (Resected Dose A and Dose B) in change from baseline in stool fat [ Time Frame: At Week 1 ]
    Change from baseline in stool fat will be analyzed using an analysis of covariance model
  • Change in stool frequency for each dose cohort [ Time Frame: From Baseline (Day 1) to Week 1 (Day 8) ]
    Stool frequency is a patient reported outcome recorded using an electronic diary (eDiary)
  • Difference between 2 dose cohorts (Resected Dose A and Dose B) in change from baseline in stool frequency [ Time Frame: At Week 1 ]
    Difference between two dose cohorts (Resected Dose A and Dose B) in change in stool frequency is determined
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Official Title  ICMJE 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
Brief Summary This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer that has been resected. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected participants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Exocrine Pancreatic Insufficiency (EPI)
Intervention  ICMJE
  • Drug: Pancrelipase
    Pancrelipase is administered orally as capsules with a meal or snack
    Other Name: Creon
  • Drug: Placebo
    Placebo is administered orally as capsule with a meal or snack
Study Arms  ICMJE
  • Experimental: Resected Participants Receiving Pancrelipase Dose A
    Resected participants are administered with Pancrelipase dose A. At week 1,5, or 9, participants who meet dose modification criteria will be administered with Pancrelipase dose B. Participants will also receive a matching placebo for blinding purposes.
    Interventions:
    • Drug: Pancrelipase
    • Drug: Placebo
  • Experimental: Resected Participants Receiving Pancrelipase Dose B
    Resected participants are administered with Pancrelipase dose B. Participants will also receive a matching placebo for blinding purposes.
    Interventions:
    • Drug: Pancrelipase
    • Drug: Placebo
  • Experimental: Non-Resected Participants Receiving Pancrelipase Dose B
    Non-resected participants are administered with Pancrelipase dose B.
    Intervention: Drug: Pancrelipase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 19, 2021)
1
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2019)
92
Estimated Study Completion Date  ICMJE December 29, 2022
Estimated Primary Completion Date June 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT03859869
Other Study ID Numbers  ICMJE M16-142
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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 and 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP