Status:
ACTIVE_NOT_RECRUITING
Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency
Lead Sponsor:
Andrew Hendifar, MD
Collaborating Sponsors:
VIVUS LLC
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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,...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04098237
Start Date
December 17 2020
End Date
January 1 2027
Last Update
May 31 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048