Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Arm 1

Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack

Group Type EXPERIMENTAL

Pertzye

Intervention Type DRUG

Treatment with standard dose or higher dose Pancrelipase will continue for 20 weeks from enrollment. Participants will consume assigned blinded weight based Pancrelipase dose concurrent with first bite of every meal and snack for the duration of enrollment.

Arm 2

Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack

Group Type EXPERIMENTAL

Pertzye

Intervention Type DRUG

Treatment with standard dose or higher dose Pancrelipase will continue for 20 weeks from enrollment. Participants will consume assigned blinded weight based Pancrelipase dose concurrent with first bite of every meal and snack for the duration of enrollment.

Interventions

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Pertzye

Treatment with standard dose or higher dose Pancrelipase will continue for 20 weeks from enrollment. Participants will consume assigned blinded weight based Pancrelipase dose concurrent with first bite of every meal and snack for the duration of enrollment.

Intervention Type DRUG

Other Intervention Names

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Pancrelipase

Eligibility Criteria

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Inclusion Criteria

* Histopathologic or cytologic diagnosis of pancreatic adenocarcinoma, or adenosquamous cancer, or any non-neuroendocrine primary pancreas variant, including acinar cancer.
* De novo or recurrent diagnosis of previously untreated stage IV PDAC with intent to receive FOLFIRINOX/mFOLFIRINOX.
* ECOG 0-2.
* No use of pancreatic enzyme replacement therapy within prior 2 weeks.
* Patients with biliary obstruction are eligible provided biliary stenting has or will occur before treatment with FOLFIRINOX.
* Ability to understand and the willingness to sign an informed consent document.
* Ability to swallow capsules.
* Age ≥18 years.
* Anticipated life expectancy of at least 6 months.

Exclusion Criteria

* Chronic illness associated with malabsorption (celiac disease, cystic fibrosis, chronic pancreatitis, Crohn's disease).
* Fibrosing colonopathy.
* Prior history of surgical resection of the pancreas or gastric bypass.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pancrelipase.
* Patients cannot receive radiation, IRE, or other localized therapy directed to the pancreas while on study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No