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A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 454 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Site details revised at 1 of 132 sitesv454
  2. Minor Site details revised at 1 of 132 sitesv453
  3. Minor Site contacts updated at 1 of 132 sitesv452
  4. Minor Site contacts updated at 1 of 132 sitesv451
  5. Minor Site contacts updated at 1 of 132 sitesv450
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Site details revised at 1 of 132 sitesv449
  2. Minor Site details revised at 1 of 132 sitesv448
  3. Minor Site details revised at 1 of 132 sitesv447
  4. Minor Site details revised at 1 of 132 sitesv446
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  6. Minor Site details revised at 1 of 132 sitesv444
  7. Minor Study sites revised (132)v443 See this version in full on ClinicalTrials.gov ↗
  8. Minor Site contacts updated at 1 of 132 sitesv442
  9. Minor Site contacts updated at 1 of 132 sitesv441
  10. Minor Study sites revised (132)v440 See this version in full on ClinicalTrials.gov ↗
  11. Minor Site contacts updated at 2 of 132 sitesv439
  12. Minor Site details revised at 1 of 132 sitesv438
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  14. Minor Site details revised at 1 of 132 sitesv436
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  20. Minor Study sites revised (132)v430 See this version in full on ClinicalTrials.gov ↗
  21. Minor Site contacts updated at 1 of 132 sitesv429
  22. Minor Site details revised at 1 of 132 sitesv428
  23. Minor Site details revised at 1 of 132 sitesv427
  24. Minor Site details revised at 1 of 132 sitesv426
  25. Minor 3 versions Re-verified since Apr 4, 2026, no change to tracked fieldsv423-v425
  26. Minor Site contacts updated at 1 of 132 sitesv422
  27. Minor Site details revised at 1 of 132 sitesv421
  28. Minor 2 versions Re-verified since Mar 31, 2026, no change to tracked fieldsv419-v420
  29. Minor Site contacts updated at 1 of 132 sitesv418
  30. Minor 12 versions Re-verified since Mar 12, 2026, no change to tracked fieldsv406-v417
  31. Minor Site details revised at 2 of 132 sitesv405
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it.
Trial Details
NCT Number NCT04166409
Lead Sponsor National Cancer Institute (NCI)
Conditions Low Grade Astrocytoma, Low Grade Glioma, Metastatic Low Grade Astrocytoma, Metastatic Low Grade Glioma, WHO Grade 1 Glioma, WHO Grade 2 Glioma
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov