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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 : Terminated (Business Considerations (difficulty with enrollment))
First Posted : March 1, 2019
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency (EPI) Drug: Pancrelipase Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 25, 2020
Actual Primary Completion Date : March 23, 2022
Actual Study Completion Date : March 23, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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
Experimental: Non-Resected Participants Receiving Pancrelipase Dose B
Non-resected participants are administered with Pancrelipase dose B.
 Drug: Pancrelipase
Pancrelipase is administered orally as capsules with a meal or snack
Other Name: Creon


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859869


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03859869    
Other Study ID Numbers: M16-142
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing, please refer to the link below.
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://vivli.org/ourmember/abbvie/

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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
Keywords provided by AbbVie:
Exocrine Pancreatic Insufficiency (EPI)
Pancreatic Cancer
Creon
Pancrelipase
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Exocrine Pancreatic Insufficiency
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
 Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents