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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 : Completed
First Posted : July 14, 2014
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
The Alfred
Information provided by (Responsible Party):
NuvOx LLC

Tracking Information
First Submitted Date  ICMJE May 19, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date February 28, 2019
Study Start Date  ICMJE May 2014
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Progression Free Survival at 6 months [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 25, 2014)
Tumor Reduction Based on Gd-MRI [ Time Frame: 4 months ]
First determination will be measured at 4 months
Original Other Pre-specified Outcome Measures
 (submitted: July 11, 2014)
  • Progression Free Survival [ Time Frame: 6-months ]
  • Tumor Reduction Based on Gd-MRI [ Time Frame: 4 months ]
    First determination will be measured at 4 months
 
Descriptive Information
Brief Title  ICMJE The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma
Official Title  ICMJE A Phase 1b Dose-finding, Pharmacokinetic and Pharmacodynamic Study of NVX-108 Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma Multiforme
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE Drug: NVX-108
0.2% emulsion administered i.v.
Other Name: Dodecafluoropentane
Study Arms  ICMJE Experimental: Dose Escalation
NVX-108 (DDFP liquid emulsion) i.v. in conjunction with Radiation Treatment and Temozolimide. 0.05-0.35cc/kg.
Intervention: Drug: NVX-108
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2019)
11
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2014)
25
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189109
Other Study ID Numbers  ICMJE NVX108-GBM1B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NuvOx LLC
Study Sponsor  ICMJE NuvOx LLC
Collaborators  ICMJE The Alfred
Investigators  ICMJE
Principal Investigator: Jason Lickliter, MBBSPhDFRACP Nucleus Network
PRS Account NuvOx LLC
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP