Clinical trial NCT02189109 (phase 1, status: completed)
Conditions: glioblastoma multiforme
ICD codes: L51.0, L51.8, L51.9
Drugs: nvx-108
SMILES: FC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F
Eligibility 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.