Clinical Trial

AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma

Study acronym: NANO-GBM
Active, Not Recruiting Phase 1/2
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Record status
This record was last updated February 13, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a phase I/II clinical trial evaluating the association of AGuIX nanoparticles with radiotherapy plus concomitant Temozolomide in the treatment of newly diagnosed glioblastoma. The primary objectives of this study were to determine the recommended dose of AGuIX in combination with radiotherapy and TMZ during the concomitant radiochemotherapy period (phase I) and to estimate the efficacy of the combination radiochemotherapy + AGuIX (recommended dose), measured by the 6-month progression-free survival rate (PFS) (phase II) Three dose levels of intravenous AGuIX nanoparticles will be explored: 50 mg/kg, 75 mg/kg and 100 mg/kg.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-05-06; most recent amendment 2025-02-11.
Status change: Recruiting → Active, Not Recruiting 2024-09-30
Status change: Not Yet Recruiting → Recruiting 2021-12-10
Trial Details
NCT Number NCT04881032
Lead Sponsor Centre Jean Perrin
Collaborators: Ministry for Health and Solidarity, France
Conditions Glioblastoma
Enrollment 66 participants
Start Date 2022-03-07
Primary Completion 2025-09 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2025-02-13