ACTIVE_NOT_RECRUITING

Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

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Conditions

Metastatic Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic CancerMetastatic Pancreatic AdenocarcinomaMetastatic Pancreatic CarcinomaPancreatic CarcinomaPancreatic Carcinoma MetastaticPancreatic Carcinoma Non-resectablePancreatic CancerPancreatic Cancer Non-resectablePancreatic Cancer Stage IVPancreatic Cancer MetastaticPDACPDAC - Pancreatic Ductal AdenocarcinomaPancrelipaseMemorial Sloan Kettering Cancer Center21-419

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to see how pancrelipase affects the body mass index (BMI) in people with metastatic PDAC. BMI is a measure based on a person's height and weight. Other study goals are to explore two different dosing schedules of pancrelipase and to evaluate pancrelipase in people who do not have symptoms of EPI.

Official Title

A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Quick Facts

Study Start:2022-11-30
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05642962

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histopathologic or cytologic diagnosis of pancreatic adenocarcinoma, or adenosquamous cancer, or any non-neuroendocrine primary pancreas variant, including acinar cancer.
  2. * De novo or recurrent diagnosis of previously untreated stage IV PDAC with intent to receive FOLFIRINOX/mFOLFIRINOX.
  3. * ECOG 0-2.
  4. * No use of pancreatic enzyme replacement therapy within prior 2 weeks.
  5. * Patients with biliary obstruction are eligible provided biliary stenting has or will occur before treatment with FOLFIRINOX.
  6. * Ability to understand and the willingness to sign an informed consent document.
  7. * Ability to swallow capsules.
  8. * Age ≥18 years.
  9. * Anticipated life expectancy of at least 6 months.
  1. * Chronic illness associated with malabsorption (celiac disease, cystic fibrosis, chronic pancreatitis, Crohn's disease).
  2. * Fibrosing colonopathy.
  3. * Prior history of surgical resection of the pancreas or gastric bypass.
  4. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pancrelipase.
  5. * Patients cannot receive radiation, IRE, or other localized therapy directed to the pancreas while on study.

Contacts and Locations

Principal Investigator

Eileen O'Reilly, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Eileen O'Reilly, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-30
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2022-11-30
Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Metastatic Pancreatic Cancer
  • Pancrelipase
  • Memorial Sloan Kettering Cancer Center
  • 21-419

Additional Relevant MeSH Terms

  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Metastatic Pancreatic Cancer
  • Metastatic Pancreatic Adenocarcinoma
  • Metastatic Pancreatic Carcinoma
  • Pancreatic Carcinoma
  • Pancreatic Carcinoma Metastatic
  • Pancreatic Carcinoma Non-resectable
  • Pancreatic Cancer
  • Pancreatic Cancer Non-resectable
  • Pancreatic Cancer Stage IV
  • Pancreatic Cancer Metastatic
  • PDAC
  • PDAC - Pancreatic Ductal Adenocarcinoma