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

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ClinicalTrials.gov Identifier: NCT02189109
Recruitment Status : Unknown
Verified September 2016 by NuvOx Pharma Pty Ltd.
Recruitment status was:  Active, not recruiting
First Posted : July 14, 2014
Last Update Posted : September 26, 2016
Sponsor:
Collaborator:
The Alfred
Information provided by (Responsible Party):
NuvOx Pharma Pty Ltd

Brief 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.

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


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: NVX-108 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation
NVX-108 (DDFP liquid emulsion) i.v. in conjunction with Radiation Treatment and Temozolimide. 0.05-0.35cc/kg.
Drug: NVX-108
0.2% emulsion administered i.v.
Other Name: Dodecafluoropentane




Primary Outcome Measures :
  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 [ Time Frame: 6 months ]
    Adverse Events are considered to be neurological and hemodynamic


Secondary Outcome Measures :
  1. Progression Free Survival at 6 months [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Tumor Reduction Based on Gd-MRI [ Time Frame: 4 months ]
    First determination will be measured at 4 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically-confirmed newly-diagnosed glioblastoma multiforme.
  2. No prior treatment for glioblastoma apart from surgical resection.
  3. No prior treatment for glioblastoma apart from surgical resection.
  4. Planned for 60 Gray of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy.
  5. 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).
  6. Aged 18-70 years.
  7. ECOG performance status 0-2.
  8. Life expectancy of at least 3 months.
  9. If receiving glucocorticoid therapy, the dose must be stable over at least 7 days prior to study enrollment.
  10. Archived tumor tissue available for central review.
  11. Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
  12. 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.
  13. 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

  14. 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.
  15. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Presence of leptomeningeal disease or multifocal glioblastoma that cannot be encompassed within a feasible and safe radiation field.
  2. Intracranial bleeding, except for stable grade 1 hemorrhage.
  3. Has not recovered from the adverse effects of surgical resection or biopsy, except for neurological deficits.
  4. Patients who have received any other investigational agent within 4 weeks before enrollment.
  5. Stroke or transient ischemic attack within 6 months before enrollment.
  6. 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).
  7. Congenital long QT syndrome.
  8. Clinically-significant chronic obstructive pulmonary disease or asthma.
  9. Active major infection requiring treatment.
  10. 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.
  11. Known infection with human immunodeficiency virus or hepatitis B or C virus.
  12. Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins or low-dose aspirin.
  13. History of allergic reactions attributed to compounds of similar chemical composition to NVX-108.
  14. Women who are pregnant or breast feeding.
  15. Inability to comply with study procedures.
  16. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189109


Locations
Australia, New South Wales
St. Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Australia, South Australia
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia, 3004
Epworth Center
Melbourne, Victoria, Australia, 3121
Sponsors and Collaborators
NuvOx Pharma Pty Ltd
The Alfred
Investigators
Principal Investigator: Jason Lickliter, MBBSPhDFRACP Nucleus Network

Responsible Party: NuvOx Pharma Pty Ltd
ClinicalTrials.gov Identifier: NCT02189109     History of Changes
Other Study ID Numbers: NVX108-GBM1B
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by NuvOx Pharma Pty Ltd:
glioblastoma
multiforme
radiation
radiation therapy

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue