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NCT04541082 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
A Phase 1 study of Glioblastoma and Anaplastic Astrocytoma, sponsored by Jazz Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT04541082: Recruiting Phase 1 study of Glioblastoma and Anaplastic Astrocytoma, sponsored by Jazz Pharmaceuticals.
NCT04541082 is a Phase 1 study of Glioblastoma and Anaplastic Astrocytoma that is actively recruiting participants, run by Jazz Pharmaceuticals. The registered enrollment target is 102 participants, roughly in line with the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04541082, a Phase 1 study of Glioblastoma and Anaplastic Astrocytoma, is actively recruiting participants, sponsored by Jazz Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
MTD was determined by testing increasing doses up to 200 mg twice daily for 3 successive days a week. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \>33% of participants. DLTs will be assessed in the first course of each cohort (28 days), and refer to a study drug-related or possibly related event that meets 1 of the following criteria defined in the subsequent Primary Outcome Measure using the National Cancer Institute Common Terminology Criteria fo
Conditions Studied
Interventions
- DRUG ONC206
Study Locations (1)
Maryland
- National Institutes of Health - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT04541082 shows while recruiting
NCT04541082 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target.
The record links to 10 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which ONC206 is the first listed.
NCT04541082 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04541082 about?
NCT04541082 is a clinical study titled "Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms". 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 regim...
What is the current status of trial NCT04541082?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2020-10-26. Estimated completion is 2026-12.
What conditions does trial NCT04541082 study?
This clinical trial studies the following conditions: Glioblastoma, Anaplastic Astrocytoma, Oligodendroglioma, Anaplastic Oligodendroglioma, Pilocytic Astrocytoma.
What interventions are being tested in trial NCT04541082?
The interventions under investigation include: ONC206 (DRUG).
Who is sponsoring clinical trial NCT04541082?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04541082 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04541082's enrollment target sits among peer trials
102 45th of 199 higher than 155 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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