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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04541082
The ClinicalTrials.gov registry entry for NCT04541082 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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