This is an international, multi-center, Phase 2b study of Azixa (verubulin) being conducted in patients with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts. Part A is an open-label dose finding study that will determine the safety and tolerability of Azixa in combination with standard treatment (including radiation therapy and temozolomide). Part B is a randomized open-label study that will investigate progression-free survival and overall survival of patients receiving Azixa, at the dose determined in Part A, in combination with standard treatment versus standard treatment alone. This study is being conducted at centers in the United States and India.

This is an open-label, multiple-dose study in subjects with glioblastoma multiforme. The primary endpoint for this study is 6-month Progression Free Survival (PFS) compared against historical control. The secondary endpoints include overall response observed over a maximum of 18 months of follow-up and overall survival. This study is being conducted at 10 sites in the US.

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