drugset / Trial / NCT04388475

Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma

NCT04388475 ↗

Phase 2 Completed 57 enrolled Oblato, Inc.
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-06-12
Primary completion
2024-05-08
Completion
2025-03-05

Drugs

EvaluationDrugModalityDoseRoute
Subject DISUFENTON Small molecule 60 mg/kg Intravenous
Subject Temozolomide Small molecule 200 mg/m2 Oral

Indications