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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
University of California at Irvine
Orange, California, United States
University of California
San Francisco, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Penn State College of Medicine, Hershey Medical Center-Penn State Neuroscience Institute
Hershey, Pennsylvania, United States
Innsbruck Universitaetsklinik
Innsbruck, Austria
Start Date
July 26, 2018
Primary Completion Date
August 23, 2022
Completion Date
June 30, 2023
Last Updated
July 1, 2025
749
ACTUAL participants
Marizomib
DRUG
Temozolomide
DRUG
radiotherapy
RADIATION
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
NCT06622434
NCT05864534
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04474353