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Trial record 1 of 1 for:    Not yet recruiting Studies | Interventional Studies | EPI | AbbVie [Lead] | M16-142
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A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)

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ClinicalTrials.gov Identifier: NCT03859869
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 exploratory cohort in non-resected participants.

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

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Study Type : Interventional
Estimated Enrollment : 92 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
Estimated Study Start Date : June 28, 2019
Estimated Primary Completion Date : December 4, 2021
Estimated Study Completion Date : December 4, 2021

Resource links provided by the National Library of Medicine


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 placebo.
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 placebo.
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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



Information from the National Library of Medicine

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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 a surgical removal of the entire pancreas.
  • 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.

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


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03859869     History of Changes
Other Study ID Numbers: M16-142
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
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)
Analytic Code
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

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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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Exocrine Pancreatic Insufficiency
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents