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A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Site details revised at 2 of 21 sitesv25
  2. Primary completion date: Dec 1, 2025 to Dec 1, 2026
    • Study sites: 20 to 21
    • Study completion date: Dec 1, 2025 to Dec 1, 2036
    v24
  3. Study sites: 16 to 20v23
  4. Site contacts updated at 1 of 16 sitesv22
  5. Site details revised at 1 of 16 sitesv21
Show 19 earlier versionsHide 19 earlier versions
  1. Re-verified, no change to tracked fieldsv20
  2. Site details revised at 2 of 16 sitesv19
  3. Re-verified, no change to tracked fieldsv18
  4. Site details revised at 2 of 16 sitesv17
  5. Study sites: 18 to 16v16
  6. Site details revised at 1 of 18 sitesv15
  7. Primary endpoints revised (4)
    • Secondary endpoints revised (2)
    • Site details revised at 2 of 18 sites
    • Study arms: 1 to 2
    v14
  8. Site contacts updated at 1 of 18 sitesv13
  9. Interventions: Larotrectinib (Drug), Larotrectinib (Procedure) to Larotrectinib (Drug), Larotrectinib surgical (Procedure)
    • Study description expanded, about 35 words
    • Site details revised at 1 of 18 sites
    v12
  10. Site details revised at 1 of 18 sitesv11
  11. Eligibility criteria shortened, about 22 wordsv10
  12. Site details revised at 3 of 18 sitesv9
  13. Study title revisedv8
  14. Study description revised
    • Site details revised at 1 of 18 sites
    v7
  15. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2021 to Apr 8, 2021
    • Site details revised at 18 of 18 sites
    v6
  16. Re-verified, no change to tracked fieldsv5
  17. Site contacts updated at 1 of 18 sitesv4
  18. Start date: Feb 1, 2021 to Apr 1, 2021v3
  19. Start date: Dec 1, 2020 to Feb 1, 2021
    • Study sites: 15 to 18
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with chemotherapy in your children; as well as the safety larotrectinib when given post-focal radiation therapy.
Trial Details
NCT Number NCT04655404
Lead Sponsor Nationwide Children's Hospital
Conditions
(from sponsor)		 High Grade Glioma, Diffuse Intrinsic Pontine Glioma
Related terms Diffuse Intrinsic Pontine Glioma, Glioma
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov