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Trial · Interventional

Active, not recruitingPhase 2Registry data

Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

NCTNCT03796884 (opens ClinicalTrials.gov in a new tab)Other id18F.524Other idCDMRP-CA170223Other idJT 13271

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
20202022202420262028
  1. Ph 2

    Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

    NCT03796884

    30 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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
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 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

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