A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme
Status:
Recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
Summary
This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study.
Patients with GBM after failure of standard first line therapy will be randomized in a 2:1
ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will
include response and progression outcomes evaluated by a blinded central reviewer for each
patient according to RANO criteria.
A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50%
of all planned patients have completed the primary endpoint at 6 months. This review will
include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment
will not be paused during this interim analysis.