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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
Must not have
Has taken linaclotide within 30 days prior to consent
At risk for obstructing or near-obstructing mechanical gastrointestinal obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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
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I have had at least one non-hereditary colorectal adenoma or I have stage 0-3 colorectal cancer and am scheduled for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken linaclotide in the last 30 days.
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I am at risk for a severe blockage in my digestive tract.
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I do not have any uncontrolled illnesses that could affect my study participation.
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I have a history of delayed stomach emptying.
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I have inflammatory bowel disease (Crohn's or ulcerative colitis).
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I have been diagnosed with a type of colitis.
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I have been diagnosed with celiac disease.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Linaclotide, a treatment for Colorectal Adenomas, functions by binding to receptors on intestinal cells, leading to increased secretion of water and salt into the intestinal lumen. This action helps to soften stools and promote bowel movements, which is crucial for patients suffering from constipation associated with Colorectal Adenomas. Effective management of bowel movements can significantly improve the quality of life for these patients by reducing symptoms such as abdominal pain, bloating, and straining. Other treatments may also target similar pathways to enhance intestinal fluid secretion and improve colonic motility.
Cyclic nucleotide concentrations in 1,2-dimethylhydrazine induced rat colon adenocarcinoma.Laxative Effects of Yangyin Tongmi Capsule on a Model of Diphenoxylate-Induced Constipation in Mice.Aldosterone induces myofibroblast EGF secretion to regulate epithelial colonic permeability.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
875 Previous Clinical Trials
329,756 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
~37 spots leftby Jun 2025