Pertzye for Pancreatic Cancer

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

17 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

The main purpose of this study is to see how pancrelipase affects the body mass index (BMI) in people with metastatic PDAC. BMI is a measure based on a person's height and weight. Other study goals are to explore two different dosing schedules of pancrelipase and to evaluate pancrelipase in people who do not have symptoms of EPI.

Research Team

Eileen O'Reilly, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+