Program Status
Active, not recruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
LinaclotideTags
MSS/ MMRpLocation | Location Status |
---|---|
United States | |
Fox Chase Cancer Center Philadelphia, Pennsylvania 19111 |
Active, not recruiting |
Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia, Pennsylvania 19126 |
Active, not recruiting |
VA Puget Sound Health Care Sysem Seattle, Washington 98108 |
Active, not recruiting |
Inclusion Criteria
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
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 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