drugset / Trial / NCT01672463

Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients

NCT01672463 ↗

Phase 1 Unknown 31 enrolled Oblato, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot cohort of human recurrent malignant glioma patients. 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 with investigational agents or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.

Timeline

Start
2012-12
Primary completion
2023-01-31
Completion
2023-10

Drugs

EvaluationDrugModalityDoseRoute
Subject DISUFENTON Small molecule 20 mg/kg Intravenous
Subject DISUFENTON Small molecule 40 mg/kg Intravenous
Subject DISUFENTON Small molecule 60 mg/kg Intravenous

Indications