<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02189109</url>
  </required_header>
  <id_info>
    <org_study_id>NVX108-GBM1B</org_study_id>
    <nct_id>NCT02189109</nct_id>
  </id_info>
  <brief_title>The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma</brief_title>
  <acronym>GBM</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NuvOx LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Alfred</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NuvOx LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is testing the safety, tolerability and effectiveness of NVX-108&#xD;
      administered via intravenous infusion in combination with standard radiation and&#xD;
      chemotherapy.&#xD;
&#xD;
      NVX-108 is being developed to increase the amount of oxygen delivered to tumors which is&#xD;
      hoped to increase the effectiveness of radiation therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <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</measure>
    <time_frame>6 months</time_frame>
    <description>Adverse Events are considered to be neurological and hemodynamic</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival at 6 months</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Tumor Reduction Based on Gd-MRI</measure>
    <time_frame>4 months</time_frame>
    <description>First determination will be measured at 4 months</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Glioblastoma Multiforme</condition>
  <arm_group>
    <arm_group_label>Dose Escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NVX-108 (DDFP liquid emulsion) i.v. in conjunction with Radiation Treatment and Temozolimide. 0.05-0.35cc/kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVX-108</intervention_name>
    <description>0.2% emulsion administered i.v.</description>
    <arm_group_label>Dose Escalation</arm_group_label>
    <other_name>Dodecafluoropentane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically-confirmed newly-diagnosed glioblastoma multiforme.&#xD;
&#xD;
          2. No prior treatment for glioblastoma apart from surgical resection.&#xD;
&#xD;
          3. No prior treatment for glioblastoma apart from surgical resection.&#xD;
&#xD;
          4. Planned for 60 Gray of focal radiation administered in 30 fractions, concurrently with&#xD;
             temozolomide chemotherapy.&#xD;
&#xD;
          5. Manageable risks associated with potential radiation necrosis in the radiation field,&#xD;
             based on size of the field and proximity to eloquent brain regions (as assessed by the&#xD;
             investigator).&#xD;
&#xD;
          6. Aged 18-70 years.&#xD;
&#xD;
          7. ECOG performance status 0-2.&#xD;
&#xD;
          8. Life expectancy of at least 3 months.&#xD;
&#xD;
          9. If receiving glucocorticoid therapy, the dose must be stable over at least 7 days&#xD;
             prior to study enrollment.&#xD;
&#xD;
         10. Archived tumor tissue available for central review.&#xD;
&#xD;
         11. Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.&#xD;
&#xD;
         12. Baseline MRI performed within 14 days before starting study treatment, while on a&#xD;
             stable glucocorticoid dose for at least 5 days before and during the imaging study.&#xD;
&#xD;
         13. Adequate hematologic, renal and hepatic function, as defined by:&#xD;
&#xD;
             Absolute neutrophil count (ANC) ≥ 1.5 109/L Platelet count ≥ 100 109/L Hemoglobin ≥ 90&#xD;
             g/L International normalized ratio (INR) and activated partial thromboplastin time&#xD;
             (APTT) &lt; 1.5 upper limit of normal (ULN) Plasma creatinine&lt; 1.5 ULN Total bilirubin&#xD;
             within normal limits (&lt; 2.5 ULN if Gilbert's syndrome) AST and ALT &lt; 2.5 ULN&#xD;
&#xD;
         14. Patients who are women of childbearing potential or men (unless vasectomised) must&#xD;
             agree to use a highly-effective method of birth control, such as hormonal&#xD;
             contraceptive implants, combined oral contraceptives, an intrauterine device, a&#xD;
             double-barrier method (eg. condom with a diaphragm) or abstinence, from study entry&#xD;
             until 4 months after completing study therapy. Should a woman become pregnant or&#xD;
             suspect she is pregnant while she or her partner is participating in this study, she&#xD;
             should inform her treating physician immediately.&#xD;
&#xD;
         15. Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of leptomeningeal disease or multifocal glioblastoma that cannot be&#xD;
             encompassed within a feasible and safe radiation field.&#xD;
&#xD;
          2. Intracranial bleeding, except for stable grade 1 hemorrhage.&#xD;
&#xD;
          3. Has not recovered from the adverse effects of surgical resection or biopsy, except for&#xD;
             neurological deficits.&#xD;
&#xD;
          4. Patients who have received any other investigational agent within 4 weeks before&#xD;
             enrollment.&#xD;
&#xD;
          5. Stroke or transient ischemic attack within 6 months before enrollment.&#xD;
&#xD;
          6. Myocardial infarction within 6 months before enrollment, unstable angina, New York&#xD;
             Heart Association class II or greater congestive heart failure, or uncontrolled&#xD;
             hypertension (systolic BP &gt; 160 mmHg and/or diastolic BP &gt; 100 mmHg).&#xD;
&#xD;
          7. Congenital long QT syndrome.&#xD;
&#xD;
          8. Clinically-significant chronic obstructive pulmonary disease or asthma.&#xD;
&#xD;
          9. Active major infection requiring treatment.&#xD;
&#xD;
         10. A history of other malignancies, except adequately treated non-melanoma skin cancer,&#xD;
             curatively treated in-situ cancer or other solid tumors curatively treated with no&#xD;
             evidence of disease for ≥ 2 years.&#xD;
&#xD;
         11. Known infection with human immunodeficiency virus or hepatitis B or C virus.&#xD;
&#xD;
         12. Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low&#xD;
             molecular weight heparins or low-dose aspirin.&#xD;
&#xD;
         13. History of allergic reactions attributed to compounds of similar chemical composition&#xD;
             to NVX-108.&#xD;
&#xD;
         14. Women who are pregnant or breast feeding.&#xD;
&#xD;
         15. Inability to comply with study procedures.&#xD;
&#xD;
         16. History or evidence of any other clinically-significant condition that, in the opinion&#xD;
             of the investigator, would pose a risk to subject safety or interfere with study&#xD;
             procedures, evaluation or completion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Lickliter, MBBSPhDFRACP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nucleus Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Vincents Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nucleus Network</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epworth Center</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3121</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>May 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glioblastoma</keyword>
  <keyword>multiforme</keyword>
  <keyword>radiation</keyword>
  <keyword>radiation therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02189109
org study id: NVX108-GBM1B
nct id: NCT02189109
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
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
description: Adverse Events are considered to be neurological and hemodynamic
measure: Progression Free Survival at 6 months
time frame: 6 months
measure: Tumor Reduction Based on Gd-MRI
time frame: 4 months
description: First determination will be measured at 4 months
arm group label: Dose Escalation
arm group type: Experimental
description: NVX-108 (DDFP liquid emulsion) i.v. in conjunction with Radiation Treatment and Temozolimide. 0.05-0.35cc/kg.
intervention type: Drug
intervention name: NVX-108
description: 0.2% emulsion administered i.v.
arm group label: Dose Escalation
other name: Dodecafluoropentane
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jason Lickliter, MBBSPhDFRACP
role: Principal Investigator
affiliation: Nucleus Network
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Glioblastoma