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Pancreaze for Pancreatic Cancer (PANCAX-3 Trial)

Phase 2
Recruiting
Led By Andrew Hendifar, MD, MPH
Research Sponsored by Andrew Hendifar, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Patients must have normal organ and marrow function as defined below:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

PANCAX-3 Trial Summary

This trial will study the effects of an advanced formulation of Pancreaze on weight, function, and quality of life in patients with pancreatic cancer.

Who is the study for?
This trial is for adults with pancreatic cancer who are experiencing weight loss and digestive issues due to the cancer affecting their pancreas' ability to aid in digestion. They should be relatively active, not have severe liver or heart conditions, and expect to live more than 3 months. Pregnant women or those unable to use birth control are excluded.Check my eligibility
What is being tested?
The study tests whether Pancreaze (pancrelipase), a medication helping with digestion, can stabilize weight and improve life quality when added to standard care in patients whose pancreas doesn't produce enough digestive enzymes due to cancer.See study design
What are the potential side effects?
Potential side effects of Pancreaze may include gastrointestinal symptoms like stomach pain, nausea, diarrhea; allergic reactions; and possibly colon strictures if used long-term at high doses.

PANCAX-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have lost at least 5% of my weight in the last 6 months due to a chronic illness.
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My organ and bone marrow functions are normal.
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I have been diagnosed with a condition where my pancreas does not produce enough enzymes.
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My pancreatic cancer is advanced and I am referred to SOCCI-CSMC.
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My kidney function, measured by creatinine or its clearance, is within the required range.
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I agree to use effective birth control or abstain from sex during and for 30 days after the study.
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I am 18 years old or older.
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I am fully active or able to carry out light work.

PANCAX-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of completing pancreatic enzyme replacement therapy during the first 8 weeks of the study: daily compliance diary
Secondary outcome measures
Change in microbiome from baseline
Mean change in average heart rate from baseline
Mean change in calories consumed from baseline through the end-of-study visit
+10 more

Side effects data

From 2022 Phase 4 trial • 36 Patients • NCT03924947
4%
NAUSEA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2 DB Creon AAPIS
Part 1 DB Creon
Part 2 DB Creon
Part 2 OL Creon Post-Randomization
Part 1 OL Creon Pre-Randomization
Part 1 DB Creon MP
Part 1 OL Creon Post-Randomization
Part 2 OL Creon Pre-Randomization

PANCAX-3 Trial Design

1Treatment groups
Experimental Treatment
Group I: Standard of care treatment with Pancreaze (pancrelipase)Experimental Treatment1 Intervention
Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pancrelipase
2011
Completed Phase 4
~160

Find a Location

Who is running the clinical trial?

VIVUS LLCIndustry Sponsor
43 Previous Clinical Trials
10,576 Total Patients Enrolled
Andrew Hendifar, MDLead Sponsor
5 Previous Clinical Trials
83 Total Patients Enrolled
Andrew Hendifar, MD, MPHPrincipal Investigator - Cedars-Sinai Medical Center
Cedars-Sinai Medical Center, Sound Physicians Platinum Group Pc
Tulane University School Of Medicine (Medical School)
2 Previous Clinical Trials
17 Total Patients Enrolled

Media Library

Pancrelipase Clinical Trial Eligibility Overview. Trial Name: NCT04098237 — Phase 2
Pancreatic Adenocarcinoma Research Study Groups: Standard of care treatment with Pancreaze (pancrelipase)
Pancreatic Adenocarcinoma Clinical Trial 2023: Pancrelipase Highlights & Side Effects. Trial Name: NCT04098237 — Phase 2
Pancrelipase 2023 Treatment Timeline for Medical Study. Trial Name: NCT04098237 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ceiling of participants in this clinical trial?

"Affirmative. According to the information located on clinicaltrials.gov, this medical research is actively seeking volunteers for participation. Initially posted in December of 2020 and recently updated in July 2022, the study needs 30 patients from a single site."

Answered by AI

Has Pancrelipase been given the green light by the FDA?

"Our company's analysis rates the safety of Pancrelipase as a 2, due to Phase 2 trial data that provides evidence supporting its security but lacks proof of effectiveness."

Answered by AI

Is this clinical trial pioneering a new approach to treatment?

"First investigated in 2011, Pancrelipase has been granted it N/A drug approval and is presently the focus of 7 active clinical trials spanning 10 countries and 38 cities. This initial research was sponsored by Boehringer Ingelheim and involved 60 participants."

Answered by AI

In what situation is Pancrelipase typically prescribed?

"Pancrelipase is a recommended treatment for diarrheal symptoms, impaired fat digestion, and post-surgical gastric resection."

Answered by AI

Are there any additional investigations involving Pancrelipase?

"Currently, there are seven active studies related to Pancrelipase. Two of these investigations have reached Phase 3 and the majority of them originate from Kansas City, Missouri with a total of fifty two trial sites across the country."

Answered by AI

Has recruitment for this study already begun?

"According to clinicaltrials.gov, this medical trial is actively recruiting with its initial posting on December 17th 2020 and most recent update occurring July 15th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency
Andrew Hendifar, MD 2020. "Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04098237.
~9 spots leftby Apr 2025
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