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Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

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NCT04541082

Sponsored by Jazz Pharmaceuticals (industry) · JAZZ — their whole pipeline →. With National Institutes of Health (NIH).

Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
102estimated
Sites
1
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2020-10-26actualWhen the study began enrolling
Primary completionJul 2026estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionDec 2026estimatedThe whole study's end, after follow-up
First posted2020-09-09actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-12-18actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Central Nervous System Neoplasms
  • Glioblastoma
  • Gliosarcoma, Adult
  • Anaplastic Oligodendroglioma
  • Anaplastic Astrocytoma
  • Pilocytic Astrocytoma
  • Oligodendroglioma
  • Gliomatosis Cerebri
  • Pleomorphic Xanthoastrocytoma
  • Anaplastic Pleomorphic Xanthoastrocytoma
  • Diffuse Midline Glioma, H3 K27M-Mutant
  • Ependymoma
  • Ependymoma, Anaplastic
  • Medulloblastoma
  • Teratoid Rhabdoid Tumor
  • Neuroectodermal Tumors, Primitive
  • Neuroectodermal Tumors
  • Anaplastic Meningioma
  • Atypical Meningioma
  • Choroid Plexus Neoplasms
  • Pineal Tumor
  • Diffuse Astrocytoma
  • Glial Tumor

Intervention

  • Drug: ONC206

Primary outcomes

what the primary-completion date above is the date OF
Maximum Tolerated Dose (MTD) of single-agent, oral ONC206
measured 28 Days
Number of Participants who Experienced Dose-Limiting Toxicities (DLTs)
measured 28 Days

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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