Pancreaze for Pancreatic Cancer

(PANCAX-3 Trial)

Overseen by Andrew Hendifar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Andrew Hendifar, MD

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests Pancreaze capsules in pancreatic cancer patients who have trouble digesting food. The medication provides missing enzymes to help them digest food better and improve their quality of life. Pancreatic enzyme supplementation is an important part of management for a number of gastrointestinal conditions.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use pancreatic enzyme supplements or over-the-counter supplements containing lipase, protease, and amylase during the trial.

What data supports the idea that Pancreaze for Pancreatic Cancer is an effective drug?

The available research does not provide direct evidence that Pancreaze is effective for treating pancreatic cancer. Instead, the studies focus on its use for conditions like cystic fibrosis and pancreatic insufficiency. For example, one study compared Pancrease and Creon in children with cystic fibrosis and found no significant differences in effectiveness. Another study showed that Creon significantly reduced fat malabsorption in patients with chronic pancreatitis. However, these studies do not address pancreatic cancer specifically. ^{1 2 3 4 5}

What safety data is available for Pancreaze and similar treatments?

Safety data for Pancreaze and similar treatments, such as CREON and Zenpep, show that these pancreatic enzyme replacement therapies (PERT) are generally well-tolerated. Common adverse events include gastrointestinal disorders and allergic skin reactions. Clinical trials have demonstrated their safety in patients with exocrine pancreatic insufficiency (EPI) due to conditions like cystic fibrosis and chronic pancreatitis. The risk of fibrosing colonopathy and viral transmission from porcine-derived products is monitored. Overall, these treatments have a favorable risk-benefit profile. ^{2 4 6 7 8}

Is Pancreaze a promising drug for pancreatic cancer?

The information provided does not directly address Pancreaze as a treatment for pancreatic cancer. The studies focus on pancreatic enzyme replacement therapies like Pancrelipase for conditions like cystic fibrosis and chronic pancreatitis, not cancer. Therefore, we cannot conclude that Pancreaze is a promising drug for pancreatic cancer based on this information. ^{1 2 4 6 9}

Research Team

Andrew Hendifar, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I have lost at least 5% of my weight in the last 6 months due to a chronic illness.

Absolute Neutrophil Count (ANC) ≥ 500/mcL

My organ and bone marrow functions are normal.

Exclusion Criteria

I cannot swallow whole capsules.

Pregnancy, breastfeeding, or of childbearing potential and not willing to use methods of birth control during the study

I am able to understand and give consent for my treatment.

Treatment Details

Interventions

• Pancrelipase (Enzyme Replacement Therapy)

Trial Overview 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.

Participant Groups

Group I: Standard of care treatment with Pancreaze (pancrelipase) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Andrew Hendifar, MD

Lead Sponsor

Trials

6

Recruited

130+

VIVUS LLC

Industry Sponsor

Trials

44

Recruited

10,600+

Findings from Research

In a study involving 39 children with cystic fibrosis, two pancreatin preparations, Pancrease and Creon, were compared for their effectiveness in fat absorption and other health indicators over four weeks.

The results indicated no significant differences in fat absorption, nitrogen excretion, weight change, or symptom scores between the two preparations, suggesting they are equally effective when dosed on a capsule-for-capsule basis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two enteric coated microspheres in cystic fibrosis. Williams, J., MacDonald, A., Weller, PH., et al.[2019]

EUR-1008 (Zenpep) is an effective treatment for cystic fibrosis patients with exocrine pancreatic insufficiency, showing significant improvements in fat and nitrogen absorption compared to placebo in a study of 34 older patients.

The treatment was safe and well tolerated across all ages, with no serious drug-related adverse events reported, and it effectively controlled malabsorption symptoms in both younger and older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. Wooldridge, JL., Heubi, JE., Amaro-Galvez, R., et al.[2021]

A new pancreatic enzyme preparation, Creon, demonstrated superior efficacy in reducing steatorrhea (fat in stool) compared to traditional pancreatin tablets, even with significantly lower lipase activity and dosage, achieving a 57% reduction in steatorrhea.

Patients using Creon experienced significant weight gain and a 70% reduction in steatorrhea after 30 days of treatment, indicating its effectiveness in managing malabsorption due to pancreatic insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of a new microencapsulated pancreatin versus a conventional preparation, in the treatment of steatorrhea of pancreatic origin]. Aparisi, L., Rodrigo, JM., Serra, MA., et al.[2009]

In a study involving 54 patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis or pancreatic surgery, pancrelipase significantly improved fat absorption (CFA) and nitrogen absorption (CNA) compared to placebo, indicating its efficacy in treating maldigestion.

The safety profile of pancrelipase was comparable to that of placebo, with similar rates of treatment-emergent adverse events, suggesting it is a safe option for patients with EPI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancrelipase delayed-release capsules (CREON) for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery: A double-blind randomized trial. Whitcomb, DC., Lehman, GA., Vasileva, G., et al.[2022]

In a study involving 96 patients with cystic fibrosis and exocrine pancreatic insufficiency, Zenpep was found to be non-inferior to Kreon in terms of fat absorption, demonstrating similar efficacy with a coefficient of fat absorption of 84.1% for Zenpep compared to 85.3% for Kreon.

Both Zenpep and Kreon showed comparable safety and tolerability profiles, making Zenpep a viable alternative for treating EPI in adolescents and adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. Taylor, CJ., Thieroff-Ekerdt, R., Shiff, S., et al.[2018]

Pancrelipase delayed-release capsules (CREON) have been shown to significantly improve fat and nitrogen absorption, as well as clinical symptoms in patients with exocrine pancreatic insufficiency (EPI) due to conditions like cystic fibrosis and chronic pancreatitis, based on double-blind, randomized trials.

CREON is well tolerated with a low incidence of adverse events, primarily gastrointestinal disorders, and has a favorable safety profile, making it an effective treatment option for EPI across various age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CREON (Pancrelipase Delayed-Release Capsules) for the treatment of exocrine pancreatic insufficiency. Kuhn, RJ., Gelrud, A., Munck, A., et al.[2022]

ZENPEP (pancrelipase) significantly improves fat absorption in patients with chronic pancreatitis and exocrine pancreatic insufficiency, with both low and high doses showing better results than placebo in a study of 72 participants.

Patients with more severe exocrine pancreatic insufficiency benefited more from the high dose of ZENPEP, indicating that dosage may need to be adjusted based on the severity of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a novel pancreatic enzyme product, EUR-1008 (Zenpep), in patients with exocrine pancreatic insufficiency due to chronic pancreatitis. Toskes, PP., Secci, A., Thieroff-Ekerdt, R.[2021]

Pancreatic enzyme products (PEPs) like Creon, Zenpep, and Pancreaze are effective and safe treatments for exocrine pancreatic insufficiency (EPI) due to conditions such as cystic fibrosis, chronic pancreatitis, and pancreatectomy, with Creon being the first-line choice.

The FDA's review of PEPs revealed significant variability in response among unapproved products, leading to a requirement for all PEPs to undergo formal approval, ensuring their efficacy and safety in clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic enzyme products: digesting the changes. Giuliano, CA., Dehoorne-Smith, ML., Kale-Pradhan, PB.[2011]

In a study of 58 patients with chronic pancreatitis and exocrine pancreatic insufficiency, pancreatic enzyme replacement therapy (PERT) using microencapsulated pancreatin significantly improved nutritional status, as indicated by increases in body mass index (BMI) in both patient groups over 8-12 months.

Laboratory markers of nutritional status, such as total protein, vitamin D, and magnesium, showed significant improvement, particularly in patients with abnormal nutritional status, highlighting the efficacy of PERT in enhancing overall health in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of pancreatic enzyme replacement therapy using microencapsulated pancreatin preparations in the correction of nutritional status in patients with chronic pancreatitis: a prospective observational study]. Bideeva, TV., Maev, IV., Kucheryavyy, YA., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Two enteric coated microspheres in cystic fibrosis. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

[Efficacy of a new microencapsulated pancreatin versus a conventional preparation, in the treatment of steatorrhea of pancreatic origin]. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Pancrelipase delayed-release capsules (CREON) for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery: A double-blind randomized trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

CREON (Pancrelipase Delayed-Release Capsules) for the treatment of exocrine pancreatic insufficiency. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a novel pancreatic enzyme product, EUR-1008 (Zenpep), in patients with exocrine pancreatic insufficiency due to chronic pancreatitis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Pancreatic enzyme products: digesting the changes. [2011]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The effectiveness of pancreatic enzyme replacement therapy using microencapsulated pancreatin preparations in the correction of nutritional status in patients with chronic pancreatitis: a prospective observational study]. [2020]