Trial · Interventional
Active, not recruitingPhase 2Registry dataLinaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
Overview
- Status
- Active, not recruiting
- Phase
- Phase 2
- Enrollment
- 150 participants (actual)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- 30 Oct 2019
- Primary completion
- Nov 2026 (estimated)
- Completion
- Jan 2027 (estimated)
- First posted
- 8 Jan 2019
- Last update posted
- 8 Oct 2026
- Conditions
- 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
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
NCT0379688430 Oct 2019 to est. Jan 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- LinaclotideDrug
- PlaceboOther
Arms2
Experimental
Arm I (linaclotide)
Patients receive linaclotide PO daily on days 1-7 and undergo standard of care colonoscopy or surgery on day 7.
Placebo comparator
Arm II (placebo)
Patients receive placebo PO QD on days 1-7 and undergo standard of care colonoscopy or surgery on day 7.
Primary outcomes1
Outcomes the sponsor listed as primary.
Pharmacodynamics effect on cGMP levels
Time frame · Up to 2 years, plus an additional 12 months for primary analysis
Registry description
Will compare cGMP levels in adenomas between study arms using a two-sample t-test (alpha=.05; two-sided) or Wilcoxon rank sum test.
Secondary outcomes(4)
Incidence of adverse events (AEs)
Time frame · From the time of first dose of linaclotide or placebo until resolution, if related to linaclotide, or through 30 days after occurrence
Registry description
All participants will be evaluated for toxicity. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be used to summarize adverse events associated with linaclotide.
Ki-67 expression
Time frame · Up to 2 years
Registry description
Wilcoxon rank sum test will be used to compare Ki-67 expression in adenomas across arms.
GUCY2C expression
Time frame · Up to 2 years
Registry description
Wilcoxon rank sum and Fisher's exact tests will be used to compare GUCY2C expression between study arms.
Guanylin levels
Time frame · Up to 2 years
Registry description
Wilcoxon rank sum and Fisher's exact tests will be used to compare guanylin levels between study arms.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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