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Pancreatic AdenocarcinomaPhase 2PANCAX-3NCT04098237

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

A Phase 2 study testing Pancrelipase in people with Pancreatic Adenocarcinoma, run by Andrew Hendifar, MD at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Pancrelipase
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
17 Dec 2020to Jan 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • Age ≥ 18 years.
  • ECOG performance status 0-1 or Karnofsky PS >60%
  • Clinical diagnosis of exocrine pancreatic insufficiency
  • 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
  • Life expectancy of greater than 3 months, in the opinion of the investigator.
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  • 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.
  • 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.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • 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.
  • Women who are pregnant or are breastfeeding
  • Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
  • Unable to swallow intact capsules
  • 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.
  • 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.
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  • Coexistent other primary malignancy
  • Pregnancy, breastfeeding, or of childbearing potential and not willing to use methods of birth control during the study
  • Active drug abuse or intoxication with any substance including alcohol (blood alcohol content >0.08%, legal driving limit)
  • Known allergy to any of the active ingredients in pancreatic enzyme supplementation
  • Concurrent use of pancreatic enzyme supplementation or over the counter supplements which contain lipase, protease, and amylase as active ingredients

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: 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.

Being tested
Pancrelipase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PancrelipaseDrug

    Pancrelipase delayed-release capsules

Study groups in NCT04098237
Study groupRoleWhat they receive
Standard of care treatment with Pancreaze (pancrelipase)ExperimentalPancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks
Receives: Drug: Pancrelipase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Completing Pancreatic Enzyme Replacement Therapy During the First 8 Weeks of the Study: Daily Compliance Diary

    Adherence to therapy of at least 50% of the needed total lipase units, recorded using a daily compliance diary.

    Measured: 8 weeks

Secondary outcomes (17)

  1. Mean Change in Weight From Baseline Through the End-of-study Visit

    Measured: 6 months

  2. Mean Change in Calories Consumed From Baseline Through the End-of-study Visit

    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.

    Measured: 6 months

  3. Mean Change in Stool Frequency From Baseline Through Cycle 3 Day 1

    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.

    Measured: 8 weeks

  4. Mean Change in Stool Consistency From Baseline Through Cycle 3 Day 1

    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).

    Measured: 8 weeks

  5. Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin A

    Measured: 6 months

  6. Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin D

    Measured: 6 months

  7. Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin E

    Measured: 6 months

  8. Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K

    Measured: 6 months

  9. Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K PT

    Measured: 6 months

  10. Change in Microbiome From Baseline

    Microbiome analysis of stool samples

    Measured: 8 weeks

  11. Mean Change in Daily Activity (Steps Taken) From Baseline

    As measured by continuous daily wearable activity monitor

    Measured: 6 months

  12. Mean Change in Daily Activity (Stairs Climbed) From Baseline

    As measured by continuous daily wearable activity monitor

    Measured: 6 months

  13. Mean Change in Sleep Disturbance From Baseline

    As measured by continuous daily wearable activity monitor

    Measured: 6 months

  14. Mean Change in Duration of Sleep Disturbances From Baseline

    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).

    Measured: 6 months

  15. Mean Change in Average Heart Rate From Baseline

    As measured by continuous daily wearable activity monitor

    Measured: 6 months

  16. Mean Change in Peak Heart Rate From Baseline

    As measured by continuous daily wearable activity monitor

    Measured: 6 months

  17. Mean Change in Daily Active Minutes From Baseline

    As measured by continuous daily wearable activity monitor

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start17 Dec 2020
  3. Primary completion12 Jan 2024
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04098237
Sponsor's protocol ID
IIT2018-29-HENDIFAR-PNCX3
Acronym
PANCAX-3
Status last verified
Jan 2026
First submitted
19 Sep 2019
Last updated
23 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pancrelipase in people with Pancreatic Adenocarcinoma, run by Andrew Hendifar, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Completing Pancreatic Enzyme Replacement Therapy During the First 8 Weeks of the Study: Daily Compliance Diary (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04098237.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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