Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency (PANCAX-3)

January 20, 2026 updated by: Andrew Hendifar, MD

Pancreatic-enzyme Replacement Therapy With Pancreaze (Pancrelipase) Delayed-release in Addition to Standard of Care for Borderline Resectable, Locally Advanced, and Advanced Pancreatic Adenocarcinoma Patients (PANCAX-3) With Cachexia and Exocrine Pancreatic Insufficiency

The objective of this study is to assess weight stability, functional changes, and quality of life when Pancreaze (pancrelipase) delayed-release 84,000-lipase units (capsules), for main meals, and 42,000-lipase units (capsules), for snacks, are added to standard of care in patients with exocrine pancreatic insufficiency due to pancreatic adenocarcinoma. This will be the first prospective study of this particular formulation in addition to standard of care in advanced pancreatic cancer patients. We will treat 40 consecutive patients with borderline resectable, locally advanced and advanced pancreatic cancer patients who present with weight loss and exocrine pancreatic insufficiency with this advanced formulation of Pancreaze.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Borderline resectable, locally advanced, and advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC (Samuel Oschin Cancer Center - Cedars Sinai Medical Center)
  2. Age ≥ 18 years.
  3. ECOG performance status 0-1 or Karnofsky PS >60%
  4. Clinical diagnosis of exocrine pancreatic insufficiency
  5. Cachexia defined as at least 5% weight loss in the presence of chronic illness, within any 6-month period prior to screening OR as documented by the medical physician based on standard diagnosis of cachexia
  6. Life expectancy of greater than 3 months, in the opinion of the investigator.

  7. Patients must have normal organ and marrow function as defined below:

    • Absolute Neutrophil Count (ANC) ≥ 500/mcL
    • Platelets ≥ 50,000/mcL
    • Total bilirubin ≤ 5X upper limit of normal (ULN)
    • AST(SGOT)/ALT(SGPT) ≤ 5 X ULN
    • Creatinine OR creatinine clearance ≤ 3 times the upper limit of normal OR ≥ 30 mL/min/1.73 m² for patients with creatinine levels above normal.
    • Note: Patients with biliary stents are eligible provided that all other inclusion criteria are met.
  8. Woman of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of signing the informed consent form, for the duration of study participation, and for at least 30 days after discontinuing from study treatment.
  9. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  2. Women who are pregnant or are breastfeeding
  3. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
  4. Unable to swallow intact capsules
  5. Fibrosing colonopathy: Patients with history of fibrosing colonopathy have been reported to experience advancement to colonic strictures with doses of lipase>6000 units/kg/meal over prolonged periods of time.
  6. History of chronic illness associated with malabsorption or nutrient deficiency including but not limited to chronic pancreatitis, cystic fibrosis, celiac disease, Crohn's disease, pernicious anemia and/or prior intestinal resection.
  7. Coexistent other primary malignancy
  8. Pregnancy, breastfeeding, or of childbearing potential and not willing to use methods of birth control during the study
  9. Active drug abuse or intoxication with any substance including alcohol (blood alcohol content >0.08%, legal driving limit)
  10. Known allergy to any of the active ingredients in pancreatic enzyme supplementation
  11. Concurrent use of pancreatic enzyme supplementation or over the counter supplements which contain lipase, protease, and amylase as active ingredients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Standard of care treatment with Pancreaze (pancrelipase)
Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks
Drug: Pancrelipase
Pancrelipase delayed-release capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Completing Pancreatic Enzyme Replacement Therapy During the First 8 Weeks of the Study: Daily Compliance Diary
Time Frame: 8 weeks
Adherence to therapy of at least 50% of the needed total lipase units, recorded using a daily compliance diary.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in Weight From Baseline Through the End-of-study Visit
Time Frame: 6 months
6 months
Mean Change in Calories Consumed From Baseline Through the End-of-study Visit
Time Frame: 6 months
As measured by Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. The ASA24 is a system to collect 24-hour food recalls and provide complete nutrient analysis of the foods and beverages consumed during the collection timeframe. The tool is used in this study to measure total calories consumed.
6 months
Mean Change in Stool Frequency From Baseline Through Cycle 3 Day 1
Time Frame: 8 weeks
As measured by patient reported number of bowel movements in the past 24 hours. In this study, higher numbers represent more severe symptoms; a reduction in number of bowel movements in the past 24 hours represents improvement in symptoms.
8 weeks
Mean Change in Stool Consistency From Baseline Through Cycle 3 Day 1
Time Frame: 8 weeks
As measured by patient reported stool consistency using the Bristol Stool Chart.The Bristol Stool Chart is a diagnostic scale to classify stool into 7 different groups, ranging from Type 1-7 (indicating solid to liquid consistency or time spent longest in the bowel to least time in the bowel). A normal stool should be either Type 3 or Type 4 (middle of the scale). Worsening of stool consistency is denoted by classifications located closer to the extreme ends of the scale (Type 1 or Type 7).
8 weeks
Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin A
Time Frame: 6 months
6 months
Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin D
Time Frame: 6 months
6 months
Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin E
Time Frame: 6 months
6 months
Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K
Time Frame: 6 months
6 months
Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K PT
Time Frame: 6 months
6 months
Change in Microbiome From Baseline
Time Frame: 8 weeks
Microbiome analysis of stool samples
8 weeks
Mean Change in Daily Activity (Steps Taken) From Baseline
Time Frame: 6 months
As measured by continuous daily wearable activity monitor
6 months
Mean Change in Daily Activity (Stairs Climbed) From Baseline
Time Frame: 6 months
As measured by continuous daily wearable activity monitor
6 months
Mean Change in Sleep Disturbance From Baseline
Time Frame: 6 months
As measured by continuous daily wearable activity monitor
6 months
Mean Change in Average Heart Rate From Baseline
Time Frame: 6 months
As measured by continuous daily wearable activity monitor
6 months
Mean Change in Peak Heart Rate From Baseline
Time Frame: 6 months
As measured by continuous daily wearable activity monitor
6 months
Mean Change in Daily Active Minutes From Baseline
Time Frame: 6 months
As measured by continuous daily wearable activity monitor
6 months
Mean Change in Duration of Sleep Disturbances From Baseline
Time Frame: 6 months
As measured by continuous daily wearable activity monitor. An absolute change in the percentage of time during nighttime sleep in which participants experienced sleep disturbance is being reported.An absolute change in percent is understood to be calculated as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Andrew Hendifar, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
VIVUS LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Hendifar, MD, MPH, Cedars-Sinai Medical 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT2018-29-HENDIFAR-PNCX3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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