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Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

Study acronym: COMPETE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv36
  2. Results first posted: Apr 6, 2026v35
  3. Re-verified, no change to tracked fieldsv34
  4. Enrollment target: 309 to 324 Secondary endpoints: details revised at 1 of 2 entriesv33 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 2 entries
  5. Secondary endpoints revised (2) Primary endpoint revisedv32 Show 1 more changeShow less
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

Show 30 earlier versionsHide 30 earlier versions
  1. Primary completion date changed from estimate of Dec 2024 to Nov 27, 2024 Completion date: Dec 2029 to Nov 2029 · Secondary endpoints: 1 to 2v31 Show 2 more changesShow less
    • Completion date: Dec 2029 to Nov 2029
    • Secondary endpoints: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 53 to 52 Primary completion date: Jun 2024 to Dec 2024 · Completion date: Jun 2029 to Dec 2029v30 Show 2 more changesShow less
    • Primary completion date: Jun 2024 to Dec 2024
    • Completion date: Jun 2029 to Dec 2029
  3. Re-verified, no change to tracked fieldsv29
  4. Study sites: 56 to 53v28
  5. Enrollment target: 302 to 309v27
  6. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 300 to confirmed 302 · Study sites: 66 to 56v26 Show 2 more changesShow less
    • Enrollment target: estimated 300 to confirmed 302
    • Study sites: 66 to 56
  7. Site details revised at 4 of 66 sitesv25
  8. Study sites: 65 to 66v24
  9. Re-verified, no change to tracked fieldsv23
  10. Study sites: 64 to 65v22
  11. Study sites: 61 to 64 Eligibility criteria expanded, about 5 wordsv21 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

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  12. Secondary endpoints: details revised at 1 of 1 entryv20
  13. Study sites: 56 to 61 Primary completion date: Dec 2023 to Jun 2024 · Completion date: May 2024 to Jun 2029 · Eligibility criteria expanded, about 13 wordsv19 Show 3 more changesShow less
    • Primary completion date: Dec 2023 to Jun 2024
    • Completion date: May 2024 to Jun 2029
    • Eligibility criteria expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 49 to 56v18
  15. Study sites: 47 to 49v17
  16. Study sites: 44 to 47v16
  17. Re-verified, no change to tracked fieldsv15
  18. Study sites: 42 to 44 Collaborators: 1 to 2v14 Show 1 more changeShow less
    • Collaborators: 1 to 2

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  19. Study sites: 41 to 42v13
  20. Study sites: 39 to 41v12
  21. Primary completion date: Dec 2020 to Dec 2023 Completion date: May 2021 to May 2024 · Site details revised at 1 of 39 sitesv11 Show 2 more changesShow less
    • Completion date: May 2021 to May 2024
    • Site details revised at 1 of 39 sites
  22. Study sites: 38 to 39v10
  23. Site details revised at 2 of 38 sitesv9
  24. Study sites: 26 to 38v8
  25. Site details revised at 2 of 26 sitesv7
  26. Eligibility criteria revised Site details revised at 8 of 26 sitesv6 Show 1 more changeShow less
    • Site details revised at 8 of 26 sites

    See this version in full on ClinicalTrials.gov ↗

  27. Eligibility criteria expanded, about 37 words Study sites revised (26)v5 Show 1 more changeShow less
    • Study sites revised (26)

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  28. Site details revised at 2 of 26 sitesv4
  29. Re-verified, no change to tracked fieldsv3
  30. Site details revised at 1 of 26 sitesv2
  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.
The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
Trial Details
NCT Number NCT03049189
Lead Sponsor ITM Solucin GmbH
Collaborators: ABX CRO, PSI CRO
Conditions Neuroendocrine Tumors
Enrollment 324 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov