NCT03345095

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

A Phase III Trial of Marizomib in Combination With Standard Temozolomide-based Radiochemotherapy Versus Standard Temozolomide-based Radiochemotherapy Alone in Patients With Newly Diagnosed Glioblastoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 749 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with Temozolomide+Radiotherapy(TMZ/RT) followed by Temozolomide (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 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.

Conditions

• Newly Diagnosed Glioblastoma

Interventions

Type	Name	Description
DRUG	Marizomib	Intravenous administration of Marizomib
DRUG	Temozolomide	Oral Administration of Temozolomide
RADIATION	radiotherapy	60 Gy in 30 fractions over 6 weeks

Timeline

• Start date: 2018-07-26
• Primary completion: 2022-08-23
• Completion: 2023-06-30
• First posted: 2017-11-17
• Last updated: 2025-07-01
• Results posted: 2024-01-31

Locations

82 sites across 12 countries: United States, Austria, Belgium, Canada, Denmark, France, Germany, Netherlands, Norway, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study