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Trial of ERapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 9, 2025 (before its estimated March 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Rapamycin Holdings, Inc. dba Emtora Biosciences to Rapamycin Holdings Inc.
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 4 of 4 sites
    • Collaborators: 1 to 2
    v27
  2. Trial status: Active, Not Recruiting to Recruitingv26 Show 6 more changesShow less
    • Primary and study completion dates: Feb 2023 to Mar 2025
    • Study sites: 7 to 4
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 26 words
    • Collaborator revised
    • Study arms: 3 to 4
  3. Collaborator revisedv25
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 7 of 7 sites
    v24
  5. 2 versions Re-verified since Apr 29, 2022, no change to tracked fieldsv22-v23
Show 20 earlier versionsHide 20 earlier versions
  1. Site contacts updated at 2 of 7 sitesv21
  2. Site details revised at 1 of 7 sitesv20
  3. Site details revised at 2 of 7 sitesv19
  4. Re-verified, no change to tracked fieldsv18
  5. Study sites: 4 to 7v17
  6. Start date: Feb 3, 2021 to Jan 18, 2021v16
  7. Site details revised at 2 of 4 sitesv15
  8. Primary and study completion dates: Jan 2023 to Feb 2023
    • Start date changed from estimate of Jan 2021 to Feb 3, 2021
    v14
  9. Study sites: 3 to 4
    • Primary and study completion dates: Dec 2022 to Jan 2023
    • Start date: Dec 2020 to Jan 2021
    v13
  10. Primary and study completion dates: Nov 2022 to Dec 2022
    • Start date: Nov 2020 to Dec 2020
    v12
  11. Study sites: 2 to 3v11
  12. Start date: Sep 2020 to Nov 2020
    • Primary and study completion dates: Aug 2022 to Nov 2022
    v10
  13. Study sites: 1 to 2
    • Start date: Aug 2020 to Sep 2020
    v9
  14. Primary endpoints revised (3)
    • Primary and study completion dates: Jun 2022 to Aug 2022
    • Start date: Jul 2020 to Aug 2020
    • Eligibility criteria expanded, about 24 words
    v8
  15. Start date: Jun 2020 to Jul 2020v7
  16. Eligibility criteria shortened, about 23 words
    • Study description expanded, about 25 words
    v6
  17. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: May 2022 to Jun 2022
    • Start date: May 2020 to Jun 2020
    • Site details revised
    v5
  18. Study sites: 0 to 1v4
  19. Start date: Feb 2020 to May 2020
    • Primary and study completion dates: Feb 2022 to May 2022
    v3
  20. Re-verified, no change to tracked fieldsv2
  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.
Patients with Familial Adenomatous Polyposis (FAP) who are undergoing endoscopic surveillance will be given Encapsulated Rapamycin (eRapa) at one of three escalating doses/schedules for 12 months with the aim of reducing polyp burden.
Trial Details
NCT Number NCT04230499
Lead Sponsor Rapamycin Holdings Inc.
Collaborators: Cancer Insight, LLC, Biodexa Pharmaceuticals
Conditions
(from sponsor)		 Familial Adenomatous Polyposis
Related terms Adenomatous Polyposis Coli
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov