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

NCT03345095 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 749

Last updated 2025-07-01

Study results available
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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

DRUG

Marizomib

Intravenous administration of Marizomib

DRUG

Temozolomide

Oral Administration of Temozolomide

RADIATION

radiotherapy

60 Gy in 30 fractions over 6 weeks

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Patrick Roth · EORTC Study Coordinator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2022-08-23
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Netherlands
  • Norway
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345095 on ClinicalTrials.gov