deltatrials
Recruiting PHASE1 INTERVENTIONAL 1-arm NCT04541082

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

A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

Sponsor: Jazz Pharmaceuticals

Conditions Anaplastic Astrocytoma Anaplastic Meningioma Anaplastic Oligodendroglioma Anaplastic Pleomorphic Xanthoastrocytoma Atypical Meningioma Central Nervous System Neoplasms Choroid Plexus Neoplasms Diffuse Astrocytoma Diffuse Midline Glioma, H3 K27M-Mutant Ependymoma Ependymoma, Anaplastic Glial Tumor Glioblastoma Gliomatosis Cerebri Gliosarcoma, Adult Medulloblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Oligodendroglioma Pilocytic Astrocytoma Pineal Tumor Pleomorphic Xanthoastrocytoma Teratoid Rhabdoid Tumor
Interventions ONC206
Updated 16 times since 2020 Last updated: Dec 17, 2025 Started: Oct 26, 2020 Primary completion: Jul 31, 2026 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Anaplastic Astrocytoma and Anaplastic Meningioma and is currently actively recruiting participants. Jazz Pharmaceuticals leads this study, which shows 16 recorded versions since 2020 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Mar 2022 · 10 months · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~Nov 2023 · 19 months · monthly snapshot~Nov 2023 – ~May 2024 · 6 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshot~Mar 2025 – ~Aug 2025 · 5 months · monthly snapshot~Aug 2025 – ~Nov 2025 · 3 months · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – present · 6 months · monthly snapshot

Change History

16 versions recorded

  1. Jan 2026 — Present [monthly]

    Recruiting PHASE1

  2. Dec 2025 — Jan 2026 [monthly]

    Recruiting PHASE1

  3. Nov 2025 — Dec 2025 [monthly]

    Recruiting PHASE1

  4. Aug 2025 — Nov 2025 [monthly]

    Recruiting PHASE1

  5. Mar 2025 — Aug 2025 [monthly]

    Recruiting PHASE1

▶ Show 11 earlier versions

  1. Sep 2024 — Mar 2025 [monthly]

    Recruiting PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1

  3. May 2024 — Jul 2024 [monthly]

    Recruiting PHASE1

  4. Nov 2023 — May 2024 [monthly]

    Recruiting PHASE1

  5. Apr 2022 — Nov 2023 [monthly]

    Recruiting PHASE1

  6. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE1

  7. May 2021 — Mar 2022 [monthly]

    Recruiting PHASE1

  8. Jan 2021 — May 2021 [monthly]

    Recruiting PHASE1

  9. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  10. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE1

  11. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Jazz Pharmaceuticals
  • National Institutes of Health (NIH)
Data source: Jazz Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations