Pertzye for Pancreatic Cancer

Not currently recruiting at 8 trial locations

Overseen By Eileen O'Reilly, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Celiac disease, Cystic fibrosis, Chronic pancreatitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how the drug Pertzye, which contains pancrelipase, affects the body mass index (BMI) of individuals with stage 4 pancreatic cancer. The study tests two different doses of Pertzye to determine which is most effective and how it functions in individuals without symptoms of exocrine pancreatic insufficiency (EPI), a condition affecting digestion. Suitable candidates for this trial have untreated stage 4 pancreatic cancer and have not used pancreatic enzyme therapy in the past two weeks. As a Phase 1, Phase 2 trial, this research seeks to understand the treatment's mechanism and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have used pancreatic enzyme replacement therapy in the two weeks before starting the trial.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that pancreatic enzyme replacement therapy, such as Pertzye, is usually well-tolerated. In past studies, patients with pancreatic cancer who used similar enzyme treatments reported few side effects. A meta-analysis, which combined results from several studies, found these therapies to be safe and helpful for patients.

These studies reported no major negative side effects, suggesting that Pertzye is likely safe for most people. However, individual experiences can differ, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Pertzye for pancreatic cancer because it offers a unique approach to managing nutritional challenges associated with the disease. Unlike standard treatments that focus solely on chemotherapy to target cancer cells, Pertzye provides enzyme supplementation to improve digestion and nutrient absorption. This treatment uses lipase, an enzyme that helps break down fats, which is particularly important for patients with pancreatic ductal adenocarcinoma who often suffer from malnutrition. By enhancing nutrient absorption, Pertzye may improve patients' quality of life and overall treatment outcomes.

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

Research has shown that pancreatic enzyme replacement therapy, such as Pertzye, can benefit people with pancreatic cancer. In this trial, participants will receive varying dosages of Pertzye: one group will receive 1350 units of lipase per kilogram of body weight per meal or snack, while another group will receive 384 units. Studies have found that these treatments can improve survival rates for those with advanced pancreatic cancer. Specifically, one study highlighted that using pancreatic enzymes reduced weight loss and helped maintain body weight during the first eight weeks of treatment. This suggests that Pertzye might enhance nutrition and health in patients with pancreatic cancer. Although more research is needed, early evidence indicates benefits in managing symptoms and possibly improving survival. ^{1 3 6 7 8}

Who Is on the Research Team?

Eileen O'Reilly, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific type of pancreatic cancer (PDAC) that hasn't been treated yet. They should be able to swallow pills, have not used enzyme therapy recently, and expect to live at least another 6 months. People can't join if they've had certain pancreas surgeries or conditions like chronic pancreatitis or Crohn's disease.

Inclusion Criteria

Anticipated life expectancy of at least 6 months.

I have stage IV pancreatic cancer and plan to receive FOLFIRINOX treatment.

I have or will have a stent for my bile duct blockage before starting FOLFIRINOX treatment.

Exclusion Criteria

I have been diagnosed with fibrosing colonopathy.

I have had surgery on my pancreas or a gastric bypass.

I have a chronic illness that affects how my body absorbs nutrients.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pancrelipase with two different dosing schedules for 4 months

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pertzye

Trial Overview The study tests how the drug Pancrelipase affects body weight and size in patients with advanced PDAC using two different dosing schedules. It also looks at its effects on those without symptoms of enzyme insufficiency.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack

Group II: Arm 1 Experimental Treatment 1 Intervention

Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11997656/

Pancreatic enzyme replacement therapy in advanced ... Pancreatic enzyme replacement therapy in advanced adenocarcinoma of the pancreas improved overall survival: a retrospective, single institution ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e16254

Effects of pancreatic enzyme replacement therapy (PERT ... Current NCCN guidelines recommend PERT in PDAC patients with PEI. However, little evidence exists regarding PERT use and clinical outcomes in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40231659/

Pancreatic enzyme replacement therapy in advanced ... Pancreatic enzyme replacement therapy in advanced adenocarcinoma of the pancreas improved overall survival: a retrospective, single institution ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S142439031830704X

Enzyme replacement improves survival among patients ... The recent ESPAC 4 study has estimated a 28% five year survival following surgery among those receiving adjuvant combination chemotherapy [1] and among patients ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.698

Effect of pancreatic enzyme replacement therapy (PERT) ... PERT usage prescribed per package insert guidance reduced wt loss/ change in BMI loss in APC over the 1st 8 weeks of therapy.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e24059

Pancreatic-enzyme replacement therapy with pancrelipase ... We report results of a single site phase 2 trial for PERT with Pancreaze® plus standard of care (SOC) chemotherapy in PDAC patients with cachexia and EPI.

7. oncotarget.com oncotarget.com/article/21659/text/

Efficacy and safety of pancreatic enzyme replacement ... In summary, our meta-analysis indicates that pancreatic enzyme replacement therapy has beneficial effects and tolerance in patients with ...

8. mdpi.com mdpi.com/2072-6694/12/2/275

Pancreatic Enzyme Replacement Therapy in ... It is expected to become the second most common cancer death by 2030 [4]. The five-year survival rate remains at a mere 9%, as patients with pancreatic cancer ...