Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated December 18, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting toxicities (DLTs) following single weekly or multiple-day weekly dose regimens of single-agent, oral ONC206 in patients with recurrent, primary central nervous system (CNS) neoplasms.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2020-09-01; most recent amendment 2025-12-17.
Status change: Not Yet Recruiting → Recruiting 2020-10-01
Status change: Recruiting → Not Yet Recruiting 2020-09-17
Trial Details
NCT Number NCT04541082
Lead Sponsor Jazz Pharmaceuticals
Collaborators: National Institutes of Health (NIH)
Conditions Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma, Adult, Anaplastic Oligodendroglioma, Anaplastic Astrocytoma, Pilocytic Astrocytoma, Oligodendroglioma, Gliomatosis Cerebri +15 more
Enrollment 102 participants
Start Date 2020-10-26
Primary Completion 2026-07 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-18