NCT03862430

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
5mo left

Started Mar 2023

Typical duration for phase_2

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2023Sep 2026

First Submitted

Initial submission to the registry

March 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
4.1 years until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

October 9, 2025

Status Verified

June 1, 2025

Enrollment Period

3.3 years

First QC Date

March 1, 2019

Last Update Submit

October 7, 2025

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    To determine progression free survival (PFS) in newly-diagnosed glioblastoma patients after treatment with NVX-108 in combination with radiation and temozolomide (TMZ)

    22 months

Secondary Outcomes (7)

  • Overall Survival

    22 Months

  • Response assessment by mRANO

    22 Months

  • Response assessment for pseudoprogression

    22 Months

  • To confirm that NanO2 re-oxygenation

    22 Months

  • To estimate the effect on the duration of functional independence

    22 Months

  • +2 more secondary outcomes

Study Arms (2)

NanO2TM

EXPERIMENTAL

NanO2TM infusion in conjunction with Radiation Treatment and temozolomide

Drug: NanO2TM

Placebo

PLACEBO COMPARATOR

Placebo Saline infusion in conjunction with Radiation Treatment and temozolomide

Drug: Placebo Saline Infusion

Interventions

NanO2TMDRUG

0.1 mL/kg NanO2 infusion

Also known as: Dodecafluoropentane emulsion (DDFPe)
NanO2TM
Placebo Saline InfusionDRUG

Saline Infusion

Also known as: 0.9N NaCl
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed, newly diagnosed primary or secondary glioblastoma multiforme.
  • Treatment plan includes 60 Gy of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy.
  • Manageable risks associated with potential radiation necrosis in the radiation field, based on size of the field and proximity to eloquent brain regions (as assessed by the investigator).
  • Aged 18 years and older.
  • Karnofsky Performance Status ≥ 70
  • Life expectancy of at least 3 months.
  • Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
  • Baseline MRI performed within 7 days before starting study treatment while on a stable or decreasing glucocorticoid dose for at least 7 days before and during the imaging study.
  • Adequate hematologic, renal and hepatic function, as defined by:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 75 x 109/L
  • Hemoglobin ≥ 10.0 g/dl
  • Serum creatinine \< 1.5 x ULN
  • Total bilirubin within normal limits (≤ 2.5 x ULN if Gilbert's syndrome)
  • Aspartate transaminase (AST) and Alanine transaminase (ALT) \< 2.5 x ULN
  • +2 more criteria

You may not qualify if:

  • Recurrent Glioblastoma
  • Prior treatment for glioblastoma apart from surgical resection.
  • Presence of multi-focal glioblastoma disease that cannot be encompassed into a radiation treatment field that would be safely treated to the prescribed radiation dose.
  • Presence of leptomeningeal disease that cannot be encompassed within a feasible and safe radiation field.
  • Intracranial bleeding, except for stable grade 1 hemorrhage or a post-operative bleed that is clearing.
  • Has not recovered from the adverse effects of surgical resection or biopsy, except for neurological deficits.
  • Subjects who have received any other investigational agent within 4 weeks before enrollment
  • Stroke or transient ischemic attack requiring hospitalization within 6 months before enrollment.
  • Myocardial infarction (MI) within 6 months before enrolment, unstable angina, New York Heart Association (NYHA) class II or greater congestive heart failure, or uncontrolled hypertension (systolic BP \> 160 mmHg and/or diastolic BP \> 100 mmHg).
  • Known History of Congenital long QT syndrome (12-lead EKG is not required).
  • Clinically significant chronic obstructive pulmonary disease or asthma.
  • Active major infection requiring treatment.
  • A history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancers or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
  • Known infection with human immunodeficiency virus or hepatitis B or C virus (testing is not required).
  • Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins, low-dose aspirin, rivaroxaban (Xarelto®), apixaban (Eliquis®), or dabigatran (Pradaxa®).
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

University of Arizona

Tucson, Arizona, 85719, United States

Location

UC Irvine Health- Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Providence St. John's Cancer Institute

Santa Monica, California, 90404, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

St. Francis Medical Center, OSF Healthcare

Peoria, Illinois, 61637, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

Location

Atlantic Health System

Summit, New Jersey, 07901, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 5, 2019

Study Start

March 31, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

October 9, 2025

Record last verified: 2025-06

Locations

US(12)