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MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 3 words
    • Study description expanded, about 3 words
    v26
  2. Eligibility criteria expanded, about 2 wordsv25
  3. Study sites: 9 to 10v24
  4. Primary completion date: Apr 10, 2025 to Apr 10, 2027v23
  5. Study sites: 8 to 9v22
Show 20 earlier versionsHide 20 earlier versions
  1. Eligibility criteria expanded, about 61 wordsv21
  2. Site contacts updated at 1 of 8 sitesv20
  3. Study sites: 7 to 8v19
  4. Study sites: 17 to 7v18
  5. 2 versions Re-verified since Aug 7, 2024, no change to tracked fieldsv16-v17
  6. Site details revised at 2 of 17 sitesv15
  7. Study sites revised (17)v14
  8. Study sites revised (17)v13
  9. Study sites: 18 to 17v12
  10. Site details revised at 1 of 18 sitesv11
  11. Site details revised at 1 of 18 sitesv10
  12. Re-verified, no change to tracked fieldsv9
  13. Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Primary completion date: Mar 15, 2025 to Apr 10, 2025
    • Study completion date: Mar 15, 2027 to Apr 10, 2027
    • Start date: Mar 15, 2023 to Apr 10, 2023
    • Site details revised at 18 of 18 sites
  14. Secondary endpoints: details revised at 1 of 4 entriesv7
  15. Start date: Dec 31, 2022 to Mar 15, 2023
    • Primary completion date: Dec 31, 2024 to Mar 15, 2025
    • Study completion date: Dec 31, 2026 to Mar 15, 2027
    • Site contacts updated at 1 of 18 sites
    v6
  16. Start date: Oct 15, 2022 to Dec 31, 2022
    • Primary completion date: Oct 15, 2024 to Dec 31, 2024
    • Study completion date: Oct 15, 2026 to Dec 31, 2026
    • Study description revised
    v5
  17. Re-verified, no change to tracked fieldsv4
  18. Start date: Jun 15, 2022 to Oct 15, 2022
    • Primary completion date: Jun 15, 2024 to Oct 15, 2024
    • Study completion date: Jun 15, 2026 to Oct 15, 2026
    v3
  19. Start date: May 15, 2022 to Jun 15, 2022
    • Primary completion date: May 15, 2024 to Jun 15, 2024
    • Study completion date: May 15, 2026 to Jun 15, 2026
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
MEKTOVI (binimetinib) is an oral, highly selective reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. The biological activity of binimetinib that has been evaluated bith in vitro and in vivo in a wide variety of tumor types In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.
Trial Details
NCT Number NCT05286788
Lead Sponsor Nationwide Children's Hospital
Collaborators: Children's Hospital Colorado
Conditions
(from sponsor)		 Adamantinous Craniopharyngioma, Recurrent Adamantinomatous Craniopharyngioma
Related terms Craniopharyngioma
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov