A PHASE 3 RANDOMIZED CONTROLLED DOUBLE-ARM OPEN-LABEL MULTI-CENTER STUDY OF VB-111 COMBINED WITH BEVACIZUMAB VS. BEVACIZUMAB MONOTHERAPY IN PATIENTS WITH RECURRENT GLIOBLASTOMA

The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.
Phase 3
NCT02511405
Neuroscience - Brain Tumor, Neuroscience
Tara L. Benkers, MD
Inclusion Criteria:
  1. First or second progression of Glioblastoma;
  2. Measurable disease by RANO criteria at progression;
  3. Patients ≥18 years of age;
  4. Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;
  5. Surgery completed at least 28 days before randomization;
  6. An interval of at least 12 weeks between prior radiotherapy or at least 23 days from prior chemotherapy, 42 days from nitrosoureas and enrollment in this study;
  7. Adequate performance, i.e."Karnofsky Performance Score" of at least 70%;
  8. Adequate renal, liver, and bone marrow function according to the following criteria:

    o Absolute neutrophil count ≥1500 cells/ml,
    o Platelets ≥ 100,000 cells/ml,
    o Total bilirubin within upper limit of normal (ULN),
    o Aspartate aminotransferase (AST) ≤ 2.0 X ULN,
    o Serum creatinine level ≤ ULN or creatinine clearance ≥ 50 ml/min for patients with creatinine levels above    normal limits (creatinine clearance calculated by the Cockcroft-Gault formula, see Appendix II),
    o PT, PTT (in seconds) not to be prolonged beyond >20% of the upper limits of normal.

Exclusion Criteria:

  1. Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab, aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib, etc.);
  2. Prior stereotactic radiotherapy;
  3. Pregnant or breastfeeding patients;
  4. Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
  5. Active infection;
  6. Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;
  7. Expected to have surgery during study period;
  8. Patients with active vascular disease, either myocardial or peripheral (i.e. acute coronary syndrome, cerebral stroke, transient ischemic attack or arterial thrombosis or symptomatic peripheral vascular disease within the past 3 months);
  9. Patients with known proliferative and/or vascular retinopathy;
  10. Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune);
  11. Patients with known active second malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and have been disease free for greater than 2 years prior to screening;
  12. Patients testing positive to one of the following viruses: HIV, HBV and HCV within the last 6 months;
  13. Patients that have undergone major surgery within the last 4 weeks before enrollment;
  14. Patients who have received treatment with any other investigational agent within 4 weeks before enrollment.
Mary Lessig
206-386-3878
206-320-2300