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.
• First or second progression of Glioblastoma;
• Measurable disease by RANO criteria at progression;
• Patients ≥18 years of age;
• Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;
• Surgery completed at least 28 days before randomization;
• 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;
• Adequate performance, i.e.Karnofsky Performance Score of at least 70%;
• Adequate renal, liver, and bone marrow function according to the following criteria:
• Absolute neutrophil count ≥1500 cells/ml,
• Platelets ≥ 100,000 cells/ml,
• Total bilirubin within upper limit of normal (ULN),
• Aspartate aminotransferase (AST) ≤ 2.0 X ULN,
• 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),
• PT, PTT (in seconds) not to be prolonged beyond >20% of the upper limits of normal.