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Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE

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

Record History

  1. Secondary endpoints: details revised at 1 of 1 entry Site details revised at 9 of 42 sitesv29 Show 1 more changeShow less
    • Site details revised at 9 of 42 sites
  2. Site details revised at 9 of 42 sitesv28
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 250 to confirmed 259 · Study sites: 45 to 42v27 Show 2 more changesShow less
    • Enrollment target: estimated 250 to confirmed 259
    • Study sites: 45 to 42
  4. Re-verified, no change to tracked fieldsv26
  5. Study sites: 43 to 45v25
Show 23 earlier versionsHide 23 earlier versions
  1. Site contacts updated at 1 of 43 sitesv24
  2. Enrollment target: 202 to 250v23
  3. Study sites: 42 to 43v22
  4. Study sites: 41 to 42v21
  5. Primary completion date: Sep 2024 to Jun 2027 Completion date: Sep 2026 to Sep 2027 · Site details revised at 3 of 41 sitesv20 Show 2 more changesShow less
    • Completion date: Sep 2026 to Sep 2027
    • Site details revised at 3 of 41 sites
  6. Study sites: 40 to 41v19
  7. Study sites revised (40)v18 See this version in full on ClinicalTrials.gov ↗
  8. Study sites: 38 to 40v17
  9. Study sites: 37 to 38v16
  10. Study sites: 36 to 37v15
  11. Study sites: 34 to 36v14
  12. Site contacts updated at 9 of 34 sitesv13
  13. Study sites: 33 to 34v12
  14. Study sites: 32 to 33v11
  15. Study sites: 31 to 32v10
  16. Study sites: 30 to 31v9
  17. Site details revised at 7 of 30 sitesv8
  18. Study sites: 18 to 30v7
  19. Study sites: 14 to 18v6
  20. Study sites: 10 to 14v5
  21. Study sites: 9 to 10v4
  22. Study sites: 8 to 9v3
  23. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 8 · Start date changed from estimate of Sep 2021 to Dec 21, 2021 · Interventions: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT (Drug), Amino-Acid Solution (Other), CAPTEM (Capecitabine and Temozolomide)… to 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT (Drug), Amino-Acid Solution (Other), CAPTEM (Capecitabine and Temozolomide)…v2 Show 3 more changesShow less
    • Study sites: 0 to 8
    • Start date changed from estimate of Sep 2021 to Dec 21, 2021
    • Interventions: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT (Drug), Amino-Acid Solution (Other), CAPTEM (Capecitabine and Temozolomide)… to 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT (Drug), Amino-Acid Solution (Other), CAPTEM (Capecitabine and Temozolomide)…
  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 the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
Trial Details
NCT Number NCT04919226
Lead Sponsor ITM Solucin GmbH
Conditions Neuroendocrine Tumors
Enrollment 259 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov