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Guanylate Cyclase-C Agonist

Linaclotide for Colorectal Cancer

Phase 2
Waitlist Available
Led By Scott Waldman, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of 1 or more sporadic colorectal adenoma on previous endoscopy (adenoma cohort) or stage 0-3 biopsy proven colorectal cancer (CRC) (colorectal cancer cohort) who are scheduled for a surgical procedure
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing how well linaclotide works in treating patients with early stage colorectal cancer. Linaclotide is a protein that makes intestinal cells secrete water and salt.

Who is the study for?
This trial is for individuals with stages 0-3 colorectal cancer or those who've had colorectal adenomas. Participants must be able to swallow capsules, sign consent forms, maintain pill diaries, and use effective contraception if of childbearing potential. Exclusions include certain digestive diseases, recent linaclotide use, other cancers treated within the last 6 months (except some skin cancers), current participation in other trials or severe health issues.Check my eligibility
What is being tested?
The study is testing how well linaclotide works for patients with early-stage colorectal cancer by comparing it to a placebo. Linaclotide is a small protein that encourages intestinal cells to release water and salt. The trial will see if this treatment can benefit patients awaiting surgery.See study design
What are the potential side effects?
Linaclotide may cause side effects such as diarrhea due to increased intestinal secretion of water and salt. It might also lead to abdominal pain, bloating, gas, or an urgent need to go to the bathroom.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had at least one non-hereditary colorectal adenoma or I have stage 0-3 colorectal cancer and am scheduled for surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Pharmacodynamics effect on cGMP levels
Secondary outcome measures
GUCY2C expression
Guanylin levels
Incidence of adverse events (AEs)
+1 more
Other outcome measures
Axin and c-Myc messenger ribonucleic acid (mRNA) levels
Beta-catenin levels
Beta-catenin nuclear localization
+2 more

Side effects data

From 2018 Phase 4 trial • 828 Patients • NCT02590432
26%
Diarrhoea
2%
Flatulence
100%
80%
60%
40%
20%
0%
Study treatment Arm
LINZESS® 145 μg (CIC)
LINZESS® 290 μg (IBS-C)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (linaclotide)Experimental Treatment1 Intervention
Patients receive linaclotide PO daily on days 1-7 and undergo standard of care colonoscopy or surgery on day 7.
Group II: Arm II (placebo)Placebo Group1 Intervention
Patients receive placebo PO QD on days 1-7 and undergo standard of care colonoscopy or surgery on day 7.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Linaclotide
2008
Completed Phase 4
~9200

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
861 Previous Clinical Trials
226,964 Total Patients Enrolled
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,681 Total Patients Enrolled
Scott Waldman, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

Media Library

Linaclotide (Guanylate Cyclase-C Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03796884 — Phase 2
Colorectal Adenomas Research Study Groups: Arm I (linaclotide), Arm II (placebo)
Colorectal Adenomas Clinical Trial 2023: Linaclotide Highlights & Side Effects. Trial Name: NCT03796884 — Phase 2
Linaclotide (Guanylate Cyclase-C Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03796884 — Phase 2

Frequently Asked Questions

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

Who is eligible to participate in this experiment?

"Participants hoping to join this trial must have adenoma and be between 18-80 years of age. The enrolment goal is 230 individuals."

Answered by AI

Does this trial represent a fresh approach?

"Since its initial clinical trial in 2007, sponsored by Baxter Healthcare Corporation, Linaclotide has become a Phase 4 drug with 51 active studies occurring across 1132 cities and 21 countries."

Answered by AI

Is there still room to participate in this research endeavor?

"Affirmative. Information available on clinicaltrials.gov indicates that this experiment, initially posted on October 30th 2019 and subsequently updated November 29th 2022, is actively seeking 230 individuals across 3 sites."

Answered by AI

To what extent does Linaclotide pose a risk to patients?

"While linaclotide has not been approved by the FDA yet, there is some evidence suggesting that it may be safe. Our team at Power gave this medication a score of 2 to reflect its status as a Phase 2 trial with preliminary safety data but no efficacy data available."

Answered by AI

Have prior experiments revealed any noteworthy findings related to Linaclotide?

"Linaclotide was first explored in a Surgical Intensive Care Unit Regional Hospital Jessa in 2007. Since then, 18375 trials have been concluded while 51 are still ongoing at various locations, mainly centered around Philadelphia, Pennsylvania."

Answered by AI

What medical conditions is Linaclotide commonly prescribed to treat?

"Linaclotide is often prescribed to assist patients with constipation-predominant irritable bowel syndrome (IBS-C). It has also shown promise as a supplement treatment for renal dysfunction, and amino acid supplementation."

Answered by AI

What is the uppermost participant limit for this research project?

"Affirmative, the clinical trial is presently recruiting participants. It was first listed on October 30th 2019 and most recently revised on November 29th 2022. The study requires 230 volunteers from 3 different locations."

Answered by AI

Does this trial impose any age qualifications on potential participants?

"For this research endeavour, participants must be of legal age and have not exceeded the octogenarian stage of life."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
scott waldman 2019. "Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03796884.
All > Colorectal Cancer Baltimore > Colorectal Cancer
~42 spots leftby Apr 2025
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