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Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant

StatusRecruiting
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 21 to 20v29
  2. Site details revised at 1 of 21 sitesv28
  3. Site details revised at 1 of 21 sitesv27
  4. Site details revised at 1 of 21 sitesv26
  5. Site details revised at 1 of 21 sitesv25
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 20 to 21v24
  2. Site details revised at 1 of 20 sitesv23
  3. Study sites: 19 to 20v22
  4. Site details revised at 1 of 19 sitesv21
  5. Study sites: 18 to 19v20
  6. Primary completion date: Aug 28, 2028 to Aug 31, 2029v19
  7. Re-verified, no change to tracked fieldsv18
  8. Primary endpoints: 4 to 5v17 Show 7 more changesShow less
    • Enrollment target: 108 to 120
    • Interventions: Everolimus (Drug), Ribociclib (Drug) to Everolimus (Drug), Ribociclib (Drug), Temozolomide (TMZ) (Drug)
    • Eligibility criteria expanded, about 60 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 192 words
    • Study title expanded, about 7 words
    • Study arms: 4 to 5
  9. Enrollment target: 100 to 108v16
  10. Site details revised at 1 of 18 sitesv15
  11. Site details revised at 2 of 18 sitesv14
  12. Site details revised at 1 of 18 sitesv13
  13. Site contacts updated at 9 of 18 sitesv12
  14. Re-verified, no change to tracked fieldsv11
  15. Trial status: Not Yet Recruiting to Recruitingv10 Show 4 more changesShow less
    • Primary completion date: Jun 28, 2028 to Aug 28, 2028
    • Study completion date: Jun 28, 2034 to Aug 28, 2034
    • Start date changed from estimate of Aug 28, 2024 to Aug 22, 2024
    • Site details revised at 18 of 18 sites
  16. Re-verified, no change to tracked fieldsv9
  17. Start date: Jul 28, 2024 to Aug 28, 2024v8
  18. Re-verified, no change to tracked fieldsv7
  19. Start date: Jun 28, 2024 to Jul 28, 2024v6
  20. Primary completion date: May 30, 2028 to Jun 28, 2028
    • Study completion date: May 30, 2034 to Jun 28, 2034
    • Start date: May 30, 2024 to Jun 28, 2024
    v5
  21. Start date: Jan 15, 2024 to May 30, 2024
    • Primary completion date: Jan 15, 2028 to May 30, 2028
    • Study completion date: Jan 15, 2034 to May 30, 2034
    v4
  22. Primary endpoints: 3 to 4
    • Eligibility criteria expanded, about 314 words
    • Study description expanded, about 36 words
    v3
  23. Start date: Aug 15, 2023 to Jan 15, 2024
    • Primary completion date: Aug 15, 2027 to Jan 15, 2028
    • Study completion date: Aug 15, 2033 to Jan 15, 2034
    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 determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant. The main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG/DIPG or DHG H3G34-mutant.
Trial Details
NCT Number NCT05843253
Lead Sponsor Nationwide Children's Hospital
Collaborators: Novartis
Conditions
(from sponsor)		 High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Glioblastoma, Glioblastoma Multiforme, Diffuse Midline Glioma, H3 K27M-Mutant, Metastatic Brain Tumor, WHO Grade III Glioma +2 more
Related terms Astrocytoma, Brain Neoplasms, Diffuse Intrinsic Pontine Glioma, Glioblastoma, Glioma
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov