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OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma

NCT03587038 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-12-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • James Battiste, MD · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2020-12-23
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03587038 on ClinicalTrials.gov