Pertzye for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen ByEileen O'Reilly, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

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

No Placebo Group

Trial Summary

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.

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.

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.

+6 more

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.

+2 more

Trial 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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment1 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 1Experimental Treatment1 Intervention

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