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Clinical trialNCT04762069Active, not recruitingPhase 2Interventional

A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme

SponsorCNS Pharmaceuticals, Inc.Enrollment252Glioblastoma Multiforme, Adult
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

48 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

France
  • Hopital Pierre Wertheimer

    Lyon, France

  • Hopital de la Timone

    Marseille, France

  • Institut de Recherche En Cancerologie de Montpellier

    Montpellier, France

  • Hopital Pitie-Salpetriere

    Paris, France

  • Institut de Cancerologie de L'Ouest

    Saint-Herblain, France

  • Nstitut Universitaire Du Cancer de Toulouse-

    Toulouse, France

  • Institut de Cancerologie Gustave-Roussy

    Villejuif, France

Italy
  • Servizio Sanitario Regionale Emilia-Romagna - Azienda Usl Di Bologna - Ospedale Bellaria

    Bologna, Italy

  • Istituto Clinico Humanitas

    Milan, Italy

Spain
  • Hospital Universitari Germans Trias I Pujol

    Badalona, Spain

  • Hospital Duran I Reynals

    L'Hospitalet de Llobregat, Spain

  • Hospital Ramón Y Cajal

    Madrid, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Regional Universitario de Malaga Carlos Haya

    Málaga, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Spain

Switzerland
  • University Hospital Zurich

    Zurich, Switzerland

United States
  • University of Arkansas

    Little Rock, Arkansas, United States

  • Southern California Permanente Medical Group

    Los Angeles, California, United States

  • University of California Irvine

    Orange, California, United States

  • University of Califonia San Diego Moores Cancer Center

    San Diego, California, United States

  • University of California San Francisco

    San Francisco, California, United States

  • Saint John'S Cancer Institute at Providence Saint John'S Health Center

    Santa Monica, California, United States

  • Hca Healthcare Research Institute

    Englewood, Colorado, United States

  • Baptist Md Anderson Cancer Center

    Jacksonville, Florida, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, United States

  • Baptist Miami

    Miami, Florida, United States

  • Piedmont Healthcare

    Atlanta, Georgia, United States

  • Rush University Cancer Center

    Chicago, Illinois, United States

  • University of Kentucky

    Lexington, Kentucky, United States

  • Tulane Cancer Center Clinic

    New Orleans, Louisiana, United States

  • Tufts Medical Center

    Boston, Massachusetts, United States

  • Umass (acc) - Hollings Cancer Center (hcc)

    Worcester, Massachusetts, United States

  • Mayo Clinic

    Rochester, Minnesota, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, United States

  • Hackensack Meridian Health

    Hackensack, New Jersey, United States

  • Rutgers University

    Piscataway, New Jersey, United States

  • Atlantic Healthcare

    Summit, New Jersey, United States

  • Roswell Park Cancer Center

    Buffalo, New York, United States

  • Duke University School of Medicine

    Durham, North Carolina, United States

  • Ohio State University

    Columbus, Ohio, United States

8 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BerubicinLomustine →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
18 May 2021
Primary completion
27 Apr 2026
Completion
15 Jul 2026
Last update posted
15 Apr 2026
Registered enrollment
252
Registry id
NCT04762069

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.