OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma (NCT03587038)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients have newly diagnosed histologically proven WHO grade III or grade IV Glioblastoma Multiforme (GBM).
2. Patients at initial presentation of GBM must undergo an adequate surgical resection of the primary lesion; patients must be registered within 49 days (7 weeks) of the surgery.
3. Patients must have available and be willing to submit a minimum of five unstained slides tumor tissue specimens from the GBM surgery or open biopsy for MGMT status analysis and molecular profile analysis.
4. ECOG performance status within 0 - 2
5. Full recovery (\< grade 1) from the adverse events associated with prior surgery or any earlier intervention and a minimum of 28 days from the administration of any investigational agent
6. Adequate renal, liver and bone marrow function: Leukocytes \>3,000/mcL; Absolute neutrophil count \>1,500/mcL; Platelets \>100,000/mcL; AST / ALT (SGPT) \<2.5 x ULN; Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except Gilbert's Syndrome, who must have a total bilirubin \< 3.0 mg/dL); Creatinine within normal limits
7. Patients must be ≥ 18 years of age
8. Patients must be willing to have blood draws for PK analysis
9. All patients must have a CT or MRI of the brain within 14 days prior to registration. The brain CT or MRI should be performed with intravenous contrast (unless contraindicated).
10. Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines.
11. Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and progression-free survival evaluation;
12. Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Stephenson Cancer Center, University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.