Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer (NCT03796884) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
United States230 participantsStarted 2019-10-30
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 p…
What they're measuring
1
Pharmacodynamics effect on cGMP levels
Timeframe: Up to 2 years, plus an additional 12 months for primary analysis
Trial details
NCT IDNCT03796884
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University