Pancreaze for Pancreatic Cancer

(PANCAX-3 Trial)

Overseen By Andrew Hendifar, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Andrew Hendifar, MD

Must be taking: Pancreatic enzymes

Must not be taking: Pancreatic enzymes

Disqualifiers: Uncontrolled illness, Pregnancy, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

36 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

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

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. ^{1 2 3 4 5}

Is Pancreaze (pancrelipase) safe for humans?

Pancreaze, also known as pancrelipase, has been shown to be generally safe in humans when used for conditions like exocrine pancreatic insufficiency. Common side effects include stomach issues and skin reactions, but serious problems are rare. It has been well tolerated in clinical studies with few people stopping treatment due to side effects. ^{1 2 3 4 5}

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 3 6 7}

How does the drug Pancreaze differ from other treatments for pancreatic cancer?

Pancreaze is a pancreatic enzyme replacement therapy (PERT) typically used for conditions like cystic fibrosis and chronic pancreatitis to aid digestion by replacing enzymes the pancreas cannot produce. Its use in pancreatic cancer is unique as it may help manage digestive issues related to the disease, but it is not a direct cancer treatment like chemotherapy or targeted therapies. ^{1 2 3 6 7}

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 6 8 9}

Who Is on the Research Team?

Andrew Hendifar, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pancreaze (pancrelipase) capsules in addition to standard of care for pancreatic adenocarcinoma

24 weeks

Regular visits as per standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pancrelipase

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Two enteric coated microspheres in cystic fibrosis. [2019]

4. 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]

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]