A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma
Status:
Active, not recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
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 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 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.
Phase:
Phase 3
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC