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A Multicenter, Open-Label Study with a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients with Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517660-27-00
Acronym
CNS-201
Enrollment
126
Registered
2024-09-26
Start date
2022-09-22
Completion date
Unknown
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma multiforme (GBM)

Brief summary

OS defined as the time from randomization until death.

Detailed description

PFS, defined as the length of time from randomization to disease progression based on MRI scan or death, whichever occurs first., EFS, defined as the length of time from randomization to disease progression, death, or discontinuation of treatment for any reason (e.g., toxicity, intolerance, disease-related conditions, or failure to respond), ORR, defined as CR + PR per RANO criteria, DCR, defined as CR + PR + SD per RANO criteria; SD is defined as lack of progression of disease based on MRI scan obtained at least (CCI) weeks after initiation of therapy

Interventions

DRUGCecenu® 40 mg Kapsel

Sponsors

Cns Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
OS defined as the time from randomization until death.

Secondary

MeasureTime frame
PFS, defined as the length of time from randomization to disease progression based on MRI scan or death, whichever occurs first., EFS, defined as the length of time from randomization to disease progression, death, or discontinuation of treatment for any reason (e.g., toxicity, intolerance, disease-related conditions, or failure to respond), ORR, defined as CR + PR per RANO criteria, DCR, defined as CR + PR + SD per RANO criteria; SD is defined as lack of progression of disease based on MRI scan obtained at least (CCI) weeks after initiation of therapy

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026