Trials / Active Not Recruiting
Active Not RecruitingNCT03587038
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
Feasibility Pilot Study of OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- University of Oklahoma · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This is a pilot study exploring the potential benefit of adding OKN-007 with Temozolomide for treatment in patients with malignant Glioblastoma undergoing adjuvant concomitant radiotherapy. This drug combination is expected to have an anti-cancer effect in patients who have experienced disease progression after first line treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OKN 007 | 400 mg OKN-007/mL in a phosphate buffer |
| DRUG | Temozolomide | 75 mg/m2 |
| RADIATION | Photon/Proton IMRT | standard of care treatment to be given 1 to 2 hours after OKN-007 |
Timeline
- Start date
- 2018-09-03
- Primary completion
- 2020-12-23
- Completion
- 2026-11-01
- First posted
- 2018-07-16
- Last updated
- 2025-12-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03587038. Inclusion in this directory is not an endorsement.