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A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

Study acronym: LIBRETTO-001
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 115 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Results first posted: Apr 16, 2026 Secondary endpoints: details revised at 2 of 17 entriesv115 Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 17 entries
  2. Primary endpoints revised (3) Secondary endpoints: 15 to 17 · Study description shortened, about 46 words · Study arms: 1 to 16v114 Show 3 more changesShow less
    • Secondary endpoints: 15 to 17
    • Study description shortened, about 46 words
    • Study arms: 1 to 16

    See this version in full on ClinicalTrials.gov ↗

  3. Completion date: Feb 2026 to Feb 2027v113
  4. Re-verified, no change to tracked fieldsv112
  5. Enrollment target: 856 to 857 Primary completion date changed from estimate of Feb 2025 to Feb 14, 2025v111 Show 1 more changeShow less
    • Primary completion date changed from estimate of Feb 2025 to Feb 14, 2025
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv110
  2. Lead sponsor: Loxo Oncology, Inc. to Eli Lilly and Company Study sites: 84 to 85 · Primary completion date: Feb 28, 2025 to Feb 2025 · Completion date: Feb 28, 2026 to Feb 2026 · 1 morev109 Show 4 more changesShow less
    • Study sites: 84 to 85
    • Primary completion date: Feb 28, 2025 to Feb 2025
    • Completion date: Feb 28, 2026 to Feb 2026
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 875 to confirmed 856 · Site details revised at 84 of 84 sitesv108 Show 2 more changesShow less
    • Enrollment target: estimated 875 to confirmed 856
    • Site details revised at 84 of 84 sites
  4. Study sites: 76 to 84v107
  5. Primary completion date: Mar 21, 2024 to Feb 28, 2025 Completion date: Sep 1, 2024 to Feb 28, 2026v106 Show 1 more changeShow less
    • Completion date: Sep 1, 2024 to Feb 28, 2026
  6. Study sites: 84 to 76v105
  7. Study sites: 85 to 84v104
  8. Study sites revised (85)v103 See this version in full on ClinicalTrials.gov ↗
  9. Site contacts updated at 1 of 85 sitesv102
  10. Site contacts updated at 3 of 85 sitesv101
  11. Site contacts updated at 1 of 85 sitesv100
  12. Study sites revised (85)v99 See this version in full on ClinicalTrials.gov ↗
  13. Site contacts updated at 1 of 85 sitesv98
  14. Site contacts updated at 1 of 85 sitesv97
  15. Primary completion date: Nov 21, 2022 to Mar 21, 2024 Enrollment target: 989 to 875 · Completion date: Nov 21, 2023 to Sep 1, 2024 · Study description expanded, about 25 wordsv96 Show 3 more changesShow less
    • Enrollment target: 989 to 875
    • Completion date: Nov 21, 2023 to Sep 1, 2024
    • Study description expanded, about 25 words

    See this version in full on ClinicalTrials.gov ↗

  16. Site contacts updated at 1 of 85 sitesv95
  17. Site contacts updated at 1 of 85 sitesv94
  18. Site details revised at 1 of 85 sitesv93
  19. Site contacts updated at 2 of 85 sitesv92
  20. Site contacts updated at 1 of 85 sitesv91
  21. Study sites revised (85)v90 See this version in full on ClinicalTrials.gov ↗
  22. Eligibility criteria expanded, about 41 words Study description shortened, about 3 words · Study title expanded, about 2 wordsv89 Show 2 more changesShow less
    • Study description shortened, about 3 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  23. Site details revised at 2 of 85 sitesv88
  24. Site contacts updated at 1 of 85 sitesv87
  25. Study sites: 84 to 85v86
  26. Study sites revised (84)v85 See this version in full on ClinicalTrials.gov ↗
  27. Study sites revised (84)v84 See this version in full on ClinicalTrials.gov ↗
  28. Study sites revised (84)v83 See this version in full on ClinicalTrials.gov ↗
  29. Study sites: 83 to 84v82
  30. Site contacts updated at 2 of 83 sitesv81
  31. Study sites revised (83)v80 See this version in full on ClinicalTrials.gov ↗
  32. Site contacts updated at 2 of 83 sitesv79
  33. Site details revised at 1 of 83 sitesv78
  34. Study sites revised (83)v77 See this version in full on ClinicalTrials.gov ↗
  35. Site contacts updated at 2 of 83 sitesv76
  36. Site details revised at 2 of 83 sitesv75
  37. Study sites revised (83)v74 See this version in full on ClinicalTrials.gov ↗
  38. Eligibility criteria expanded, about 56 words Study description expanded, about 102 words · Study sites revised (83) · Study title shortened, about 1 wordv73 Show 3 more changesShow less
    • Study description expanded, about 102 words
    • Study sites revised (83)
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  39. Primary completion date: Mar 2022 to Nov 21, 2022 Primary endpoints revised (3) · Enrollment target: 970 to 989 · Study sites: 84 to 83 · 7 morev72 Show 10 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: 970 to 989
    • Study sites: 84 to 83
    • Completion date: May 2022 to Nov 21, 2023
    • Start date: May 9, 2017 to May 2, 2017
    • Interventions: LOXO-292 (selpercatinib) (Drug) to LOXO-292 (Drug)
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 14 to 15
    • Study description expanded, about 55 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  40. Eligibility criteria expanded, about 8 wordsv71 See this version in full on ClinicalTrials.gov ↗
  41. Eligibility criteria shortened, about 110 words Collaborators expanded, about 4 wordsv70 Show 1 more changeShow less
    • Collaborators expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  42. Interventions: LOXO-292 (Drug) to LOXO-292 (selpercatinib) (Drug) Secondary endpoints revised (14) · Eligibility criteria expanded, about 5 wordsv69 Show 2 more changesShow less
    • Secondary endpoints revised (14)
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  43. Study sites: 89 to 84v68
  44. Study sites: 88 to 89v67
  45. Study sites: 87 to 88v66
  • 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.
Eli Lilly
359 trials monitored
See 15 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
and 1 more disease
This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
Trial Details
NCT Number NCT03157128
Lead Sponsor Eli Lilly and Company
Collaborators: Loxo Oncology, Inc.
Conditions Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Any Solid Tumor
Enrollment 857 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov