Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Public ClinicalTrials.gov record NCT04541082. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04541082
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 102 participants
Conditions and interventions
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
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 25, 2020
- Primary completion
- Jun 30, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Dec 17, 2025
2020 – 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health | Bethesda | Maryland | 20892 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04541082, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 17, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04541082 live on ClinicalTrials.gov.