Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
Public ClinicalTrials.gov record NCT04388475. 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 Phase II Open-label Study Investigating the Efficacy, Safety and Pharmacokinetic Properties of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide(TMZ) in patients with recurrent glioblastoma(GBM). All patients will have been previously treated with the standard-of-care treatment which includes surgical resection, radiation and chemotherapy, and in some cases treatment for recurrent disease. Patients with unequivocal recurrence (first or greater) established by MRI and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.
Study identification
- NCT ID
- NCT04388475
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 57 participants
Conditions and interventions
Conditions
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
- Jun 12, 2020 (Actual)
- Primary completion
- May 8, 2024 (Actual)
- Completion
- Mar 5, 2025 (Actual)
- Last update posted
- Aug 12, 2025
2020 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 13
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| Providence Saint John's Health Center - John Wayne Cancer Institute | Santa Monica | California | 90404 | — |
| Swedish Medical Center | Englewood | Colorado | 80113 | — |
| AdventHealth Orlando | Orlando | Florida | 32804 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Norton Healthcare | Louisville | Kentucky | 40241 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | — |
| The University of Toledo | Toledo | Ohio | 43606 | — |
| The University of Oklahoma | Oklahoma City | Oklahoma | 73117 | — |
| Lifespan Office of Research | Providence | Rhode Island | 02903 | — |
| St. Joseph Hospital of Orange | Seattle | Washington | 35143 | — |
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 NCT04388475, 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 Aug 12, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04388475 live on ClinicalTrials.gov.