NCT03862430

A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM

A Phase II Double-blind, RandomizEd, Prospective, Placebo Controlled STudy of NanO2TM Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma multiformE: RESTORE

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: NuvOx LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is testing the safety and efficacy of NanO2TM administered via intravenous infusion in combination with standard radiation and chemotherapy. NanO2TM is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.

Detailed description

All study participants will receive standard care for GBM including Temozolomide and radiation therapy. Subjects will be randomized on a 2 to 1 basis to receive either NanO2 infusions or saline infusions immediately prior to standard radiation therapy. Radiation therapy is performed 5 days a week for 6 weeks. Radiation therapy is followed 28 days of recovery, and then six cycles of maintenance Temozolomide therapy on days 1 to 5 of six 28 day cycles. Follow up will be every 3 months for 3 years, and then every 6 months for another 2 years.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	NanO2TM	0.1 mL/kg NanO2 infusion
DRUG	Placebo Saline Infusion	Saline Infusion

Timeline

• Start date: 2023-03-31
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2019-03-05
• Last updated: 2025-10-09

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study