A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme
- Resolved Date
- 3/25/25
- Study Completion
- 3/31/26
- Company
- CNS Pharmaceuticals, Inc.
- Ticker
- CNSP
- Type
- Trial Status
- Active Not Recruiting
- Trial Size
- 210
- Volume
- $0
- NCT
- NCT04762069
- Drug Description
- 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.
- Outcome
- NO
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
Public readout was negative for this Phase 2 trial: the sponsor said the primary analysis did not show a statistically significant overall-survival benefit, and later described the study as not meeting its primary target. Comparable secondary/clinical observations do not override the failed primary endpoint.
Sponsor: Berubicin showed outcomes comparable to lomustine on multiple measures, but the analysis did not demonstrate statistically significant superiority in overall survival, the primary endpoint.
Company update: the Berubicin study did not meet its primary target; management said it yielded insight on safety/activity but is preparing regulatory discussions on the program’s future.
SEC filing states topline data showed Berubicin had clinically relevant outcomes that appeared comparable to lomustine, but it did not demonstrate a statistically significant difference in overall survival, the primary endpoint.
