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Glioblastoma MultiformePhase 1GBMNCT02189109

The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma

A Phase 1 study testing NVX-108 in people with Glioblastoma Multiforme, run by NuvOx LLC at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial is testing the safety, tolerability and effectiveness of NVX-108 administered via intravenous infusion in combination with standard radiation and chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
NVX-108
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
4 sitesAustralia
Study dates
May 2014to Apr 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically-confirmed newly-diagnosed glioblastoma multiforme.
  • No prior treatment for glioblastoma apart from surgical resection.
  • No prior treatment for glioblastoma apart from surgical resection.
  • Planned for 60 Gray 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 18-70 years.
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  • ECOG performance status 0-2.
  • Life expectancy of at least 3 months.
  • If receiving glucocorticoid therapy, the dose must be stable over at least 7 days prior to study enrollment.
  • Archived tumor tissue available for central review.
  • Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
  • Baseline MRI performed within 14 days before starting study treatment, while on a stable glucocorticoid dose for at least 5 days before and during the imaging study.
  • Adequate hematologic, renal and hepatic function, as defined by:
  • Absolute neutrophil count (ANC) ≥ 1.5 109/L Platelet count ≥ 100 109/L Hemoglobin ≥ 90 g/L International normalized ratio (INR) and activated partial thromboplastin time (APTT) < 1.5 upper limit of normal (ULN) Plasma creatinine< 1.5 ULN Total bilirubin within normal limits (< 2.5 ULN if Gilbert's syndrome) AST and ALT < 2.5 ULN
  • Patients who are women of childbearing potential or men (unless vasectomised) must agree to use a highly-effective method of birth control, such as hormonal contraceptive implants, combined oral contraceptives, an intrauterine device, a double-barrier method (eg. condom with a diaphragm) or abstinence, from study entry until 4 months after completing study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Presence of leptomeningeal disease or multifocal glioblastoma that cannot be encompassed within a feasible and safe radiation field.
  • Intracranial bleeding, except for stable grade 1 hemorrhage.
  • Has not recovered from the adverse effects of surgical resection or biopsy, except for neurological deficits.
  • Patients who have received any other investigational agent within 4 weeks before enrollment.
  • Stroke or transient ischemic attack within 6 months before enrollment.
  • Myocardial infarction within 6 months before enrollment, unstable angina, New York Heart Association class II or greater congestive heart failure, or uncontrolled hypertension (systolic BP > 160 mmHg and/or diastolic BP > 100 mmHg).
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  • Congenital long QT syndrome.
  • 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 cancer 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.
  • Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins or low-dose aspirin.
  • History of allergic reactions attributed to compounds of similar chemical composition to NVX-108.
  • Women who are pregnant or breast feeding.
  • Inability to comply with study procedures.
  • History or evidence of any other clinically-significant condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with study procedures, evaluation or completion.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Flinders Medical Centre

    Adelaide, South Australia, 5042

  • St. Vincents Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Nucleus Network

    Melbourne, Victoria, 3004

  • Epworth Center

    Melbourne, Victoria, 3121

Other trials in Australia

About this study

Official title: A Phase 1b Dose-finding, Pharmacokinetic and Pharmacodynamic Study of NVX-108 Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma Multiforme

This clinical trial is testing the safety, tolerability and effectiveness of NVX-108 administered via intravenous infusion in combination with standard radiation and chemotherapy.

NVX-108 is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.

Being tested
NVX-108
Keywords
glioblastoma, multiforme, radiation, radiation therapy
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NVX-108Drug

    Also called Dodecafluoropentane

    0.2% emulsion administered i.v.

Study groups in NCT02189109
Study groupRoleWhat they receive
Dose EscalationExperimentalNVX-108 (DDFP liquid emulsion) i.v. in conjunction with Radiation Treatment and Temozolimide. 0.05-0.35cc/kg.
Receives: Drug: NVX-108

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability of NVX-108 in Combination with Radiation and Temozolomide Defined by no Drug related Adverse Events (AE) in No More than 1 Patient per Treatment Group

    Adverse Events are considered to be neurological and hemodynamic

    Measured: 6 months

Secondary outcomes (1)

  1. Progression Free Survival at 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2014 (estimated)
  2. Study startMay 2014
  3. Primary completion31 Aug 2017
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02189109
Sponsor's protocol ID
NVX108-GBM1B
Acronym
GBM
Status last verified
Feb 2019
First submitted
19 May 2014
Last updated
28 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Lickliter JD, Ruben J, Kichenadasse G, Jennens R, Gzell C, Mason RP, Zhou H, Becker J, Unger E, Stea B. Dodecafluoropentane Emulsion as a Radiosensitizer in Glioblastoma Multiforme. Cancer Res Commun. 2023 Aug 21;3(8):1607-1614. doi: 10.1158/2767-9764.CRC-22-0433. eCollection 2023 Aug.

    PubMed 37609003

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NVX-108 in people with Glioblastoma Multiforme, run by NuvOx LLC at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of NVX-108 in Combination with Radiation and Temozolomide Defined by no Drug related Adverse Events (AE) in No More than 1 Patient per Treatment Group (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02189109, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.

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