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ACTIVE NOT RECRUITING
NCT03862430
PHASE2

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

Sponsor: NuvOx LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

87

Start Date

2023-03-31

Completion Date

2026-09-30

Last Updated

2025-10-09

Healthy Volunteers

No

Interventions

DRUG

NanO2TM

0.1 mL/kg NanO2 infusion

DRUG

Placebo Saline Infusion

Saline Infusion

Locations (12)

Center for Neurosciences

Tucson, Arizona, United States

University of Arizona

Tucson, Arizona, United States

UC Irvine Health- Chao Family Comprehensive Cancer Center

Orange, California, United States

Providence St. John's Cancer Institute

Santa Monica, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

St. Francis Medical Center, OSF Healthcare

Peoria, Illinois, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Atlantic Health System

Summit, New Jersey, United States

Duke University Medical Center

Durham, North Carolina, United States

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States