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A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

Study acronym: SCOUT
StatusActive, Not Recruiting
PhasePhase 1/2
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 111 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (45)v111 See this version in full on ClinicalTrials.gov ↗
  2. Study sites revised (45)v110 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (45)v109 See this version in full on ClinicalTrials.gov ↗
  4. Study sites revised (45)v108 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (45)v107 See this version in full on ClinicalTrials.gov ↗
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (45)v106 See this version in full on ClinicalTrials.gov ↗
  2. Primary completion date changed from estimate of Jan 7, 2026 to Jul 20, 2024 Study sites revised (45)v105 Show 1 more changeShow less
    • Study sites revised (45)

    See this version in full on ClinicalTrials.gov ↗

  3. 3 versions Re-verified since Sep 11, 2024, no change to tracked fieldsv102-v104
  4. Primary completion date: Jul 25, 2024 to Jan 7, 2026 Study sites: 42 to 45 · Completion date: Sep 22, 2026 to Sep 30, 2026v101 Show 2 more changesShow less
    • Study sites: 42 to 45
    • Completion date: Sep 22, 2026 to Sep 30, 2026
  5. 3 versions Re-verified since Mar 22, 2024, no change to tracked fieldsv98-v100
  6. Enrollment target: estimated 155 to confirmed 154 Study sites revised (42)v97 Show 1 more changeShow less
    • Study sites revised (42)

    See this version in full on ClinicalTrials.gov ↗

  7. Site details revised at 1 of 42 sitesv96
  8. Site details revised at 1 of 42 sitesv95
  9. 3 versions Re-verified since Aug 25, 2023, no change to tracked fieldsv92-v94
  10. Trial status: Recruiting to Active, Not Recruiting Study sites: 51 to 42 · Primary completion date: Jul 20, 2025 to Jul 25, 2024v91 Show 2 more changesShow less
    • Study sites: 51 to 42
    • Primary completion date: Jul 20, 2025 to Jul 25, 2024
  11. Study sites revised (51)v90 See this version in full on ClinicalTrials.gov ↗
  12. Study sites revised (51)v89 See this version in full on ClinicalTrials.gov ↗
  13. Eligibility criteria shortened, about 22 words Study description shortened, about 66 words · Site details revised at 4 of 51 sites · Study arms: 8 to 6v88 Show 3 more changesShow less
    • Study description shortened, about 66 words
    • Site details revised at 4 of 51 sites
    • Study arms: 8 to 6

    See this version in full on ClinicalTrials.gov ↗

  14. Primary completion date: Jun 30, 2025 to Jul 20, 2025v87
  15. Primary completion date: Jul 1, 2026 to Jun 30, 2025 Study sites revised (51)v86 Show 1 more changeShow less
    • Study sites revised (51)

    See this version in full on ClinicalTrials.gov ↗

  16. Re-verified, no change to tracked fieldsv85
  17. Site details revised at 1 of 51 sitesv84
  18. 4 versions Re-verified since Jul 18, 2022, no change to tracked fieldsv80-v83
  19. Study sites revised (51)v79 See this version in full on ClinicalTrials.gov ↗
  20. Study sites: 50 to 51v78
  21. Enrollment target: 174 to 155 Study arms: 6 to 8v77 Show 1 more changeShow less
    • Study arms: 6 to 8
  22. Primary completion date: Sep 22, 2026 to Jul 1, 2026v76
  23. Re-verified, no change to tracked fieldsv75
  24. Study sites: 49 to 50v74
  25. Site details revised at 1 of 49 sitesv73
  26. Study sites revised (49)v72 See this version in full on ClinicalTrials.gov ↗
  27. Re-verified, no change to tracked fieldsv71
  28. Primary endpoints: 3 to 4 Interventions: Larotrectinib (Vitravki, BAY2757556) (Drug) to Larotrectinib (Vitrakvi, BAY2757556) (Drug) · Eligibility criteria revised · Secondary endpoints: 24 to 22 · 2 morev70 Show 5 more changesShow less
    • Interventions: Larotrectinib (Vitravki, BAY2757556) (Drug) to Larotrectinib (Vitrakvi, BAY2757556) (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 24 to 22
    • Site details revised at 3 of 49 sites
    • Study arms: 11 to 6

    See this version in full on ClinicalTrials.gov ↗

  29. Study sites revised (49)v69 See this version in full on ClinicalTrials.gov ↗
  30. Site details revised at 1 of 49 sitesv68
  31. Study sites revised (49)v67 See this version in full on ClinicalTrials.gov ↗
  32. Study sites: 48 to 49v66
  33. Study sites: 47 to 48v65
  34. Study sites: 45 to 47v64
  35. Study sites: 42 to 45v63
  36. Study sites: 41 to 42v62
  • 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.
Bayer
131 trials monitored
See 7 trials at risk
The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.
Trial Details
NCT Number NCT02637687
Lead Sponsor Bayer
Conditions Solid Tumors Harboring NTRK Fusion
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov