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A Phase 1b Study of PTC596 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma and High Grade Glioma

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv33
  2. Study Identification, Study Statusv32
  3. Study Identification, Study Status, Oversightv31
  4. 2 versions Re-verified since Aug 7, 2024, no change to tracked fieldsv29-v30
  5. Primary completion date changed from estimate of Aug 1, 2024 to Mar 1, 2024v28
Show 26 earlier versionsHide 26 earlier versions
  1. Primary completion date: Mar 1, 2024 to Aug 1, 2024v27
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v26
  3. Primary completion date: Jul 1, 2023 to Mar 1, 2024
    • Study completion date: Jul 1, 2028 to Mar 1, 2029
    v25
  4. Primary endpoints: 3 to 5
    • Secondary endpoints revised (2)
    v24
  5. Study description shortened, about 45 words
    • Site details revised at 1 of 10 sites
    v23
  6. Re-verified, no change to tracked fieldsv22
  7. Primary completion date: Jul 1, 2022 to Jul 1, 2023
    • Study completion date: Jul 1, 2027 to Jul 1, 2028
    v21
  8. Enrollment target: 54 to 64
    • Eligibility criteria expanded, about 43 words
    • Study description expanded, about 44 words
    v20
  9. Re-verified, no change to tracked fieldsv19
  10. Eligibility criteria expanded, about 10 words
    • Study description expanded, about 19 words
    v18
  11. Site details revised at 1 of 10 sitesv17
  12. Site details revised at 1 of 10 sitesv16
  13. Site contacts updated at 1 of 10 sitesv15
  14. Site contacts updated at 1 of 10 sitesv14
  15. Site details revised at 1 of 10 sitesv13
  16. Lead sponsor: Children's Hospital Medical Center, Cincinnati to Nationwide Children's Hospital
    • Study sites: 9 to 10
    v12
  17. Site contacts updated at 1 of 9 sitesv11
  18. Re-verified, no change to tracked fieldsv10
  19. Enrollment target: 30 to 54
    • Eligibility criteria shortened, about 13 words
    • Study description shortened, about 6 words
    • Site details revised at 2 of 9 sites
    v9
  20. Site details revised at 2 of 9 sites
    • Eligibility criteria shortened, about 5 words
    v8
  21. Site details revised at 1 of 9 sitesv7
  22. Study sites: 8 to 9v6
  23. Site contacts updated at 1 of 8 sitesv5
  24. Study sites: 1 to 8
    • Eligibility criteria shortened, about 61 words
    v4
  25. Study description revisedv3
  26. Trial status: Not Yet Recruiting to Recruiting
    • Interventions: PTC596 (Drug) to PTC596 (Drug), Radiotherapy (Radiation)
    • Site details revised
    • Study description expanded, about 1 word
    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.
The goal of this study is to evaluate the safety of the study drug PTC596 (Unesbulin) taken in combination with radiotherapy (RT) when given to pediatric patients newly diagnosed with High-Grade Glioma (HGG) including diffuse intrinsic pontine glioma (DIPG). The main aims of the study are to: * Find the safe dose of the study drug PTC596that can be given without causing serious side effects. * Find out the amount of drug that enters blood (in all patients) and tumor (in patients who receive drug prior to a planned surgery for removal of their brain tumor) During the first cycle (6-7weeks), patients will receive drug orally twice a week in combination with daily RT. During subsequent cycles (4 weeks each), they will receive only the study drug orally twice a week. Funding Source - FDA OOPD
Trial Details
NCT Number NCT03605550
Lead Sponsor Nationwide Children's Hospital
Collaborators: PTC Therapeutics
Conditions
(from sponsor)		 High Grade Glioma, Diffuse Intrinsic Pontine Glioma
Related terms Diffuse Intrinsic Pontine Glioma, Glioma
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov