Linaclotide for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies how well linaclotide works in patients with early-stage colorectal cancer. Linaclotide helps the intestines release water and salt by binding to cell receptors. Researchers want to see if it affects cancer-related markers. Linaclotide is an FDA-approved drug primarily used for treating chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on chronic anti-coagulants or non-NSAID anti-platelet agents, you may need to stop them if they can't be safely discontinued before study procedures.
How does the drug Linaclotide differ from other treatments for colorectal cancer?
Linaclotide is unique for colorectal cancer treatment because it contains linalool, a compound known for its ability to induce cancer cell death (apoptosis) by generating hydroxyl radicals specifically in cancer cells, which is different from traditional chemotherapy drugs like irinotecan that target rapidly dividing cells more broadly.12345
Who Is on the Research Team?
Scott Waldman, MD
Principal Investigator
Sidney Kimmel Cancer Center at Thomas Jefferson University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive linaclotide or placebo orally daily for 7 days and undergo standard of care colonoscopy or surgery on day 7
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for secondary outcomes and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Linaclotide
Linaclotide is already approved in United States, European Union, Canada for the following indications:
- Chronic idiopathic constipation
- Irritable bowel syndrome with constipation (IBS-C)
- Functional constipation in pediatric patients 6 to 17 years of age
- Chronic idiopathic constipation
- Irritable bowel syndrome with constipation (IBS-C)
- Chronic idiopathic constipation
- Irritable bowel syndrome with constipation (IBS-C)
- Functional constipation in pediatric patients 6 to 17 years of age
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Cancer Center at Thomas Jefferson University
Lead Sponsor
United States Department of Defense
Collaborator