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PNOC016NCT03893487

Fimepinostat in Treating Brain Tumors in Children and Young Adults

StatusCompleted
PhaseEarly Phase 1
Primary completion
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 38 versions: 33 with changes below, 5 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Study completion date changed from estimate of Aug 31, 2027 to Oct 28, 2026
  2. Eligibility criteria shortened, about 24 words
    • Site details revised at 12 of 19 sites
    • Collaborators: details revised at 1 of 3 entries
  3. Collaborators revised (3)v35
  4. Primary completion date changed from estimate of Jun 1, 2023 to Oct 31, 2022
    • Study completion date: Dec 1, 2027 to Aug 31, 2027
    v33
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 19 of 19 sites
    v30
Show 27 earlier versionsHide 27 earlier versions
  1. Primary completion date: Dec 1, 2022 to Jun 1, 2023v29
  2. Primary completion date: Jun 1, 2022 to Dec 1, 2022
    • Study sites: 18 to 19
    • Study completion date: Jun 1, 2027 to Dec 1, 2027
    v28
  3. Study sites: 17 to 18v27
  4. Site contacts updated at 1 of 17 sitesv26
  5. Site contacts updated at 5 of 17 sitesv25
  6. Study sites: 16 to 17v24
  7. Study sites: 15 to 16v23
  8. Study sites: 14 to 15v22
  9. Study sites: 13 to 14v20
  10. Study sites: 12 to 13v19
  11. Study sites: 11 to 12v18
  12. Study sites: 10 to 11v17
  13. Study sites: 9 to 10v16
  14. Study sites: 8 to 9v15
  15. Study sites: 7 to 8v14
  16. Eligibility criteria expanded, about 107 words
    • Site contacts updated at 1 of 7 sites
    v13
  17. Primary completion date: Jun 2022 to Jun 1, 2022
    • Study completion date: Jun 2027 to Jun 1, 2027
    • Eligibility criteria expanded, about 84 words
    • Study description expanded, about 2 words
    v12
  18. Study sites: 6 to 7v11
  19. Study sites: 5 to 6v10
  20. Study sites: 4 to 5v9
  21. Study sites: 3 to 4v8
  22. Study sites: 2 to 3v7
  23. Study sites: 1 to 2v6
  24. Start date changed from estimate of Jul 2019 to Aug 7, 2019v5
  25. Start date: May 2019 to Jul 2019v4
  26. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 2019 to May 2019
    • Site details revised
    v3
  27. Start date: Apr 2019 to Jun 2019v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Penetration of fimepinostat across the blood brain barrier (BBB)
Timeframe: During surgery or biopsy

Arms and interventions

Treatment (fimepinostat, tumor resection)Experimental

Patients receive fimepinostat by mouth once daily, on Days -2 to 0. Within 2 hours of receiving fimepinostat on Day 0, patients undergo tumor resection or biopsy as part of their standard of care. MAINTENANCE PHASE: Patients receive fimepinostat by mouth, once daily for days 1-5 each week. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 12 months from the time treatment begins. Should patients continue to derive clinical benefit, and not experience excess toxicity or progression, patients can continue to receive drug for up to 24 months or longer pending discussion with study chairs and study sponsor.

Drugs: Fimepinostat

Procedures: Therapeutic Conventional Surgery

Sites

19 sites in 2 countries

United States 18, Switzerland 1