Trials / Active Not Recruiting

Active Not RecruitingNCT03796884

Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

Phase II Randomized, Placebo-Controlled Trial of Linaclotide to Demonstrate Bioactivity in Patients With Sporadic Colorectal Adenomas and With Colorectal Cancer

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 230 (estimated)

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
Sex: Female
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether, compared to placebo, linaclotide administered as a single oral daily dose x 7 days, induces a pharmacodynamics (PD) effect on cGMP levels, based on biopsy samples of adenomas or resected colorectal adenocarcinomas. SECONDARY OBJECTIVES: I. To compare Ki-67, guanylin levels and GUCY2C expression in adenomas and cancers versus normal tissue after exposure to linaclotide or placebo. II. To confirm the safety and tolerability of linaclotide in sporadic adenoma and cancer patients. TRANSLATIONAL OBJECTIVE: I. To assess the pharmacodynamic effect of linaclotide on pathway-specific biomarkers relevant to GUCY2C signaling (i.e. VASP phosphorylation), markers of mutant APC-beta-catenin signaling (beta-catenin levels, beta-catenin nuclear localization, axin levels, c-Myc levels, guanylin levels, PCNA expression), based on adenoma/cancer and normal mucosa biopsy samples obtained by endoscopy following linaclotide or placebo exposure. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive linaclotide orally (PO) daily on days 1-7 and undergo standard of care colonoscopy or surgery on day 7. ARM II. Patients receive placebo PO QD on days 1-7 and undergo standard of care colonoscopy or surgery on day 7. After completion of study treatment, patients are followed up at day 14.

Conditions

Interventions

Type	Name	Description
DRUG	Linaclotide	Given PO
OTHER	Placebo	Given PO

Timeline

Start date: 2019-10-30
Primary completion: 2026-06-30
Completion: 2026-06-30
First posted: 2019-01-08
Last updated: 2026-04-02

Locations

3 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03796884. Inclusion in this directory is not an endorsement.