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Enzyme Replacement Therapy
Pertzye for Pancreatic Cancer
Phase 1 & 2
Recruiting
Led By Eileen O'Reilly, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
De novo or recurrent diagnosis of previously untreated stage IV PDAC with intent to receive FOLFIRINOX/mFOLFIRINOX.
Age ≥18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial looks at how a pancreatic enzyme affects BMI in people w/ metastatic pancreatic cancer, & whether 2 dosing schedules can help those w/out EPI symptoms.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Pancrelipase may cause allergic reactions in some people, especially those who are sensitive to similar drugs. Other potential side effects could include digestive issues due to the enzymes' action.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stage IV pancreatic cancer and plan to receive FOLFIRINOX treatment.
Select...
I am 18 years old or older.
Select...
I can swallow pills.
Select...
I can take care of myself and perform daily activities.
Select...
My cancer is a type of pancreatic cancer, but not related to the hormone-producing cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in body mass index/BMI from baseline to 4 months
Side effects data
From 2014 Phase 3 trial • 41 Patients • NCT021373822%
Constipation
2%
Diarrhea
2%
Abdominal pain lower
2%
decreased appetite
2%
Gastric pH decreased
2%
hypoglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Creon N
Creon®
Trial Design
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
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,841 Total Patients Enrolled
Eileen O'Reilly, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
880 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I have been diagnosed with fibrosing colonopathy.I have had surgery on my pancreas or a gastric bypass.I am 18 years old or older.I can swallow pills.I haven't used pancreatic enzyme replacement therapy in the last 2 weeks.I have a chronic illness that affects how my body absorbs nutrients.I can take care of myself and perform daily activities.My cancer is a type of pancreatic cancer, but not related to the hormone-producing cells.I am not receiving any local treatments to the pancreas during the study.You have had allergic reactions to similar medicines as Pancrelipase.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2
- Group 2: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants in this research endeavor?
"Affirmative. According to information posted on clinicaltrials.gov, the trial commenced enrollment on November 30th 2022 and is actively searching for 40 patients at a single centre."
Answered by AI
How many people are enrolled in the experiment?
"Affirmative. Clinicaltrials.gov reveals this medical trial is still recruiting participants and the initial posting date was November 30th 2022 with no updates since then. The study requires 40 individuals across a single location for participation."
Answered by AI
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