← Back to Search

Sulindac for Pancreatic Cancer Prevention

Phase 2
Recruiting
Led By Peter Allen, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is a man or woman between the ages of 21 and 85 (inclusive) years.
Female subjects who are of childbearing potential or are capable of becoming pregnant must be willing to use appropriate methods of contraception for the length of the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing whether sulindac can prevent progression of high-risk intraductal papillary mucinous neoplasms (IPMNs) of the pancreas. Patients without contraindications will be considered to be eligible and will have a cross-sectional imaging study of the pancreas. Patients will be randomized to receive either sulindac (200 mg p.o. BID) plus standard radiographic and endoscopic surveillance or placebo plus standard radiographic and endoscopic surveillance.

Who is the study for?
This trial is for adults aged 21-85 with high-risk IPMN of the pancreas, who are medically fit for an endoscopic ultrasound and can undergo imaging studies. Women able to have children must use contraception during the study. Exclusions include heart failure, recent cancer treatments, certain surgical histories, severe drug reactions to contrast agents or NSAIDs, recent heart attacks or bypass surgery, and ongoing renal insufficiency or other conditions that conflict with sulindac use.Check my eligibility
What is being tested?
The trial tests if sulindac (a nonsteroidal anti-inflammatory drug) can prevent progression of pancreatic lesions in patients with high-risk IPMNs compared to a placebo. Participants will receive either sulindac (400 mg daily) or a placebo alongside standard surveillance over up to three years. The process includes random assignment into groups considering prior dysplasia and metformin usage.See study design
What are the potential side effects?
Potential side effects from sulindac may include gastrointestinal issues like ulcers and bleeding, allergic reactions especially in those sensitive to NSAIDs, kidney problems due to reduced function from long-term use, cardiovascular events such as heart attack or stroke risk increase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 85 years old.
Select...
I am willing to use birth control during the study.
Select...
I am able to care for myself and perform daily activities.
Select...
I have a pancreatic cyst larger than 1 cm or specific markers indicating IPMN.
Select...
I am medically cleared to have an endoscopic ultrasound.
Select...
My condition is classified as high-risk IPMN.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of patients with IPMN progression as measured by a composite of several indicators
Secondary outcome measures
Percent of patients with cyst progression as measured by radiographic images
Other outcome measures
Percent of patients with Inflammatory Marker Progression

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SulindacExperimental Treatment1 Intervention
Patients will be randomized to receive standard radiographic/endoscopic surveillance plus sulindac. The sulindac starting dose is 200 mg by mouth 2x daily. Patients will continue drug for 3 years during follow-up.
Group II: PlaceboPlacebo Group1 Intervention
Patients will be randomized to receive standard radiographic/endoscopic surveillance plus placebo. Patients will continue placebo for 3 years during follow-up.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,969 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,259 Previous Clinical Trials
14,820,553 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,255 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04207944 — Phase 2
Intraductal Papillary Mucinous Neoplasm Research Study Groups: Sulindac, Placebo
Intraductal Papillary Mucinous Neoplasm Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04207944 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04207944 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in the current clinical research?

"To fulfil the requirements of this trial, 200 qualifying individuals must take part. Patients have the option to join at various sites including Baltimore's Johns Hopkins University and Durham's Duke University Medical Center."

Answered by AI

What are the safety implications of administering Sulindac 400 MG to patients?

"Despite the lack of efficacy data, a score of 2 has been assigned to sulindac 400 MG on account of its safety record in previous Phase 2 trials."

Answered by AI

May I be considered for enrollment in this study?

"To qualify as a participant in this medical experiment, applicants must possess ipmn and be between 21 to 85 years of age. A maximum of 200 patients will be chosen for the clinical trial."

Answered by AI

Are there still opportunities for individuals to join this research effort?

"According to the official records on clinicaltrials.gov, this medical research project is currently recruiting suitable participants. This trial was initially listed back in July of 2020 and has seen its most recent update as recently as February 16th 2022."

Answered by AI

Are there multiple American sites carrying out this research endeavor?

"This research is currently running at 4 separate locations, situated in Baltimore, Durham and Boston among others. To reduce the burden of transportation for participants, we urge them to select a nearby clinic when enrolling."

Answered by AI

Is the participant pool limited to adults over 18 years of age?

"The participation requirements of this clinical trial stipulate that potential subjects must be aged between 21 and 85."

Answered by AI

Is this an unprecedented research endeavor?

"Presently, there are 4 ongoing Sulindac 400 MG trials in 623 cities across 2 countries. The original study for this drug was conducted by Cancer Prevention Pharmaceuticals Inc., and concluded its Phase 3 approval stage in 2013 with 1340 participants involved. In the eight years since then, an additional 18329 studies have been completed regarding Sulindac 400 MG."

Answered by AI

Have there been any other investigations involving Sulindac 400 MG?

"Sulindac 400 MG was initially trialled in 2013 at Lake Norman Hematology Oncology Speicalists-Mooresville. Since then, 18329 clinical trials have been concluded with 4 still active studies happening primarily in Baltimore, Maryland."

Answered by AI

To what ailments is Sulindac 400 MG conventionally employed?

"Sulindac 400 MG is a viable remedy for treating acute subacromial bursitis, osteoarthritis (OA), and acute supraspinatus tendinitis."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
65+
What site did they apply to?
Memorial Sloan Kettering
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Memorial Sloan Kettering: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)
2020. "The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04207944.
~47 spots leftby Aug 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top