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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new use of Pancreaze (pancrelipase), a medication that may help people with pancreatic cancer maintain their weight, improve daily function, and enjoy a better quality of life. It focuses on individuals with a type of pancreatic cancer who also experience weight loss and difficulty digesting food properly. Participants will take Pancreaze capsules with meals and snacks over 24 weeks. Individuals with pancreatic cancer who have experienced significant weight loss and digestive issues might be a good fit for this trial. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

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.

Is there any evidence suggesting that Pancreaze is likely to be safe for humans?

Research shows that pancrelipase, the treatment under study, is generally well-tolerated by patients. In earlier studies, patients using pancrelipase experienced better weight stability and digestive health. For example, one study found that pancrelipase reduced fat in stools and improved consistency, indicating enhanced digestion and nutrient absorption.

Pancrelipase is already used for other conditions requiring pancreatic enzyme replacement, and its safety profile is well-established. Some individuals might experience mild side effects like stomach pain or gas, but these are usually not serious. Overall, the treatment is considered safe when used as directed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Pancrelipase is unique because it specifically targets the digestive challenges associated with pancreatic cancer by supplementing the enzymes that the pancreas can no longer produce effectively. Unlike standard chemotherapy or radiation treatments, which directly target cancer cells, Pancrelipase focuses on improving nutritional absorption and overall digestive health in patients. Researchers are excited about this treatment because it could significantly enhance quality of life and nutritional status for pancreatic cancer patients, potentially supporting better outcomes alongside other cancer therapies.

What evidence suggests that Pancreaze might be an effective treatment for pancreatic cancer?

Studies have shown that pancreatic enzyme replacement therapy, such as Pancreaze, effectively treats pancreatic exocrine insufficiency, a condition often seen in people with pancreatic cancer. Research indicates that Pancreaze aids nutrient absorption, particularly fats and proteins, by providing essential digestive enzymes. One study found that patients using this therapy lived longer and maintained their weight better than those who did not. Another study reported that 96.7% of patients adhered to the treatment plan and experienced either stable disease or some improvement. In this trial, participants will receive standard care treatment with Pancreaze. Overall, Pancreaze is considered a safe and effective way to manage digestive issues related to pancreatic cancer. ^{1 3 4 6 7}

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

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]

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]

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]

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]

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]

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]

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]

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]

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