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

NCT04098237 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: IIT2018-29-HENDIFAR-PNCX3
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (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.

  8 weeks

Secondary Outcomes (17)

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

  6 months

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

  6 months

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

  8 weeks

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

  8 weeks

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

  6 months

Study Arms (1)

Standard of care treatment with Pancreaze (pancrelipase)

EXPERIMENTAL

Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks

Drug: Pancrelipase

Interventions

Pancrelipase DRUG

Pancrelipase delayed-release capsules

Standard of care treatment with Pancreaze (pancrelipase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Andrew Hendifar, MD: lead
• VIVUS LLC: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Pancrelipase

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Results Point of Contact

• Title: Dr. Andrew Hendifar, MD
• Organization: Cedars-Sinai Medical Center

andrew.hendifar@cshs.org

310-423-2217

Study Officials

• Andrew Hendifar, MD, MPH

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: December 17, 2020
• Primary Completion: January 12, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 23, 2026
• Results First Posted: March 7, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)