Serum creatinine 30 mL/min(using the Cockcroft-Gault formula).ALT, AST, alkaline phosphatase (ALP) ≤ 2.5 × ULN.Platelet count of ≥ 100×10*9/L independent of transfusion.The patient shows adequate organ functions as assessed by the specified laboratory values within 2 weeks prior to randomization defined as adequate bone marrow, renal and hepatic function within the following ranges: Patient has undergone a brain MRI within 14 days of randomization but after intervention (resection or biopsy).The patient has a life expectancy of at least 3 months.Stable or decreasing dose of steroids for at least 1 week prior to inclusion.The patient is at least 18 years of age on day of signing informed consent.Recovered from effects of surgery, postoperative infection and other complications of surgery (if any).
Patient must be eligible for standard TMZ/RT + TMZ.Availability of FFPE tumor block or 24 unstained slides for MGMT analysis.Tumor resection (gross total or partial), or biopsy only.Histologically confirmed newly diagnosed glioblastoma (WHO grade IV).Condition or diseaseĭrug: Marizomib Drug: Temozolomide Radiation: radiotherapy In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT ->TMZ, a phase III study is considered essential to establishing its impact on overall survival. Based on encouraging observations, a phase I/II trial of marizomib in combination with TMZ/RT ->TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Why Should I Register and Submit Results?.