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Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later across 2 updates Jun 30, 2026 → Nov 2026
See other at-risk trials from Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 30, 2026 to Nov 2026
    • Study completion pushed from Sep 30, 2026 to Jan 2027
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 3 of 4 entries
  2. Primary and study completion pushed from Jun 30, 2026 to Sep 30, 2026v22
  3. Enrollment reduced: 230 → 150 participants
    • Study sites revised (3)
    v21
  4. Re-verified, no change to tracked fieldsv20
  5. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2026v19
Show 17 earlier versionsHide 17 earlier versions
  1. Re-verified, no change to tracked fieldsv18
  2. Primary completion date: Dec 30, 2022 to Jun 30, 2025
    • Study completion date: Dec 30, 2024 to Jun 30, 2025
    v17
  3. Re-verified, no change to tracked fieldsv16
  4. Primary completion date changed from estimate of Oct 2023 to Dec 30, 2022
    • Study completion date: Oct 2023 to Dec 30, 2024
    v15
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v14
  6. Primary and study completion dates: Oct 1, 2022 to Oct 2023v13
  7. Re-verified, no change to tracked fieldsv12
  8. Primary and study completion dates: Oct 1, 2021 to Oct 1, 2022v11 Show 4 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description expanded, about 124 words
    • Site contacts updated at 1 of 3 sites
  9. Primary completion date: Oct 1, 2020 to Oct 1, 2021v10
  10. Site details revised at 1 of 3 sitesv9
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2019 to Oct 30, 2019
    • Site details revised at 3 of 3 sites
    v8
  12. Start date: Sep 2019 to Oct 2019v7
  13. Start date: Jul 2019 to Sep 2019v6
  14. Start date: May 2019 to Jul 2019
    • Eligibility criteria expanded, about 42 words
    v5
  15. Start date: Feb 22, 2019 to May 2019v4
  16. Study sites: 1 to 3
    • Study description shortened, about 13 words
    v3
  17. Start date: Mar 2019 to Feb 22, 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03796884
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 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 +3 more
Related terms Colorectal Neoplasms
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov