Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Colorectal Adenoma, Stage 0 Colorectal Cancer AJCC v8, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8
In brief
This phase II trial studies the how well linaclotide works in treating patients with stages 0-3 colorectal cancer. Linaclotide is a very small protein that binds to receptors on intestinal cells and makes them secrete water and salt.
Key facts
- Study ID
- NCT03796884
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- People needed
- 150
- Starts
- 2019-10-30
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Ability to understand and willingness to sign a written informed consent document and follow study procedures
- Ability to swallow capsules without difficulty
- Ability to maintain pill diaries
- Willingness to employ adequate contraception for men and women of childbearing potential for the duration of the study. Acceptable methods include double barrier methods, intrauterine device (IUD), postmenopausal status, and/or documentation of surgical sterilization
- Participants must have no chronic, clinically severe health issues which, in the opinion of their physician or the research team, could preclude trial activities including the one week drug exposure phase
You may not qualify if…
- History of gastroparesis
- History of celiac disease
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- Microscopic colitis, including collagenous colitis
- Has taken linaclotide within 30 days prior to consent
- Any malignancy except colorectal cancer or any active radiotherapy or cytotoxic chemotherapy within the last 6 months of baseline. Participants with a history of basal cell or squamous cell skin cancer may be enrolled at the discretion of the investigator
- Participants may not be receiving any other investigational agents, or be active participants in any clinical trials. If participants previously participated in a clinical trial, a 30 day washout period for the investigational drug is needed before the participant can be considered for this study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to linaclotide
- Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or lactating women
- History of bleeding/coagulation problems. Concurrent use of nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin is acceptable
- Any medical condition judged by the investigator to constitute a risk to safe participation
- At risk for obstructing or near-obstructing mechanical gastrointestinal obstruction
- Chronic use of anti-coagulants or non-NSAID anti-platelet agents will serve as an exclusion only when such medications cannot be safely discontinued before study related endoscopy or surgery
Where it is running
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- VA Puget Sound Health Care Sysem — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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