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Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

NCT03796884 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-04-02

No results posted yet for this study

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.

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

Interventions

DRUG

Linaclotide

Given PO

OTHER

Placebo

Given PO

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Scott Waldman, MD · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03796884 on ClinicalTrials.gov