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Active, not recruiting Phase 2 Interventional

A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme

ClinicalTrials.gov ID: NCT04762069

Public ClinicalTrials.gov record NCT04762069. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 8:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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 After Failure of Standard First Line Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04762069
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
CNS Pharmaceuticals, Inc.
Industry
Enrollment
252 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 18, 2021 (Actual)
Primary completion
Apr 27, 2026 (Estimated)
Completion
Jul 15, 2026 (Estimated)
Last update posted
Apr 15, 2026

2021 – 2026

United States locations

U.S. sites
32
U.S. states
21
U.S. cities
31
Facility City State ZIP Site status
University of Arkansas Little Rock Arkansas 72205 —
Southern California Permanente Medical Group Los Angeles California 90027 —
University of California Irvine Orange California 92868 —
University of Califonia San Diego Moores Cancer Center San Diego California 92093 —
University of California San Francisco San Francisco California 94143 —
Saint John's Cancer Institute at Providence Saint John's Health Center Santa Monica California 90404 —
HCA Healthcare Research Institute Englewood Colorado 80113 —
Baptist MD Anderson Cancer Center Jacksonville Florida 32207 —
Mayo Clinic Florida Jacksonville Florida 32224 —
Baptist Miami Miami Florida 33176 —
Piedmont Healthcare Atlanta Georgia 30309 —
Rush University Cancer Center Chicago Illinois 60612 —
University of Kentucky Lexington Kentucky 40536 —
Tulane Cancer Center Clinic New Orleans Louisiana 70112 —
Tufts Medical Center Boston Massachusetts 02111 —
UMass (ACC) - Hollings Cancer Center (HCC) Worcester Massachusetts 01655 —
Mayo Clinic Rochester Minnesota 550905 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Hackensack Meridian Health Hackensack New Jersey 07601 —
Rutgers University Piscataway New Jersey 08854 —
Atlantic Healthcare Summit New Jersey 07901 —
Roswell Park Cancer Center Buffalo New York 14263 —
Duke University School of Medicine Durham North Carolina 27710 —
Ohio State University Columbus Ohio 43210 —
Providence Health Portland Oregon 97225 —
Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
Texas Oncology PA Austin Texas 78758 —
Baylor Research Institute Dallas Texas 75246 —
University of Texas Health Science Center at Houston Houston Texas 77027 —
Huntsman Cancer Center Salt Lake City Utah 84112 —
Swedish Medical Center Seattle Washington 98122 —
University of Wisconsin Hospital and Clinics Madison Wisconsin 53705 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04762069, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 15, 2026 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04762069 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →