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NCT05561374 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma
A Phase 1 study of Glioblastoma Multiforme and High Grade Glioma, sponsored by Oblato.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 4
- Study locations
NCT05561374 is a Phase 1 study of Glioblastoma Multiforme and High Grade Glioma that is active but no longer recruiting, run by Oblato. The registered enrollment target is 16 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (84% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT05561374, a Phase 1 study of Glioblastoma Multiforme and High Grade Glioma, is active but no longer recruiting, sponsored by Oblato.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase 1 open-label, multicenter study to investigate tolerability, safety and PK properties of oral OKN-007 in patients with recurrent high-grade glioma.
Conditions Studied
Interventions
- DRUG Low-dose OKN-007, BID
- DRUG Low-dose OKN-007, TID
- DRUG Mid-dose OKN-007, TID
- DRUG High-dose OKN-007, TID
Study Locations (4)
California
- Providence Saint John's Cancer Institute - Santa Monica
Kentucky
- Norton Healthcare - Louisville
North Carolina
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Oklahoma
- The University of Oklahoma Health Sciences Center, Stephenson Cancer Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05561374
The ClinicalTrials.gov registry entry for NCT05561374 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (84% lower). The listed sponsor is Oblato, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 4 interventions - of which Low-dose OKN-007, BID is the first listed.
NCT05561374 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Kentucky, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05561374 about?
NCT05561374 is a clinical study titled "Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma". This is a phase 1 open-label, multicenter study to investigate tolerability, safety and PK properties of oral OKN-007 in patients with recurrent high-grade glioma.
What is the current status of trial NCT05561374?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-04-17. Estimated completion is 2025-06-30.
What conditions does trial NCT05561374 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, High Grade Glioma, Astrocytoma, Oligodendroglioma.
What interventions are being tested in trial NCT05561374?
The interventions under investigation include: Low-dose OKN-007, BID (DRUG), Low-dose OKN-007, TID (DRUG), Mid-dose OKN-007, TID (DRUG), High-dose OKN-007, TID (DRUG).
Who is sponsoring clinical trial NCT05561374?
This trial is sponsored by Oblato, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05561374 being conducted?
This trial has 4 study locations across California, Kentucky, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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