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
Categories (click each to see list of all clinical trials associated with that category): Brain/Neuro (ONC)
Current Status: Open
Phase: II/III (Cancer Control)
Principal Investigator: Shonka, Nicole
Eligibility: https://clinicaltrials.gov/study/NCT04762069?term=NCT04762069&rank=1
Summary
Primary Objective
To assess the effect of berubicin compared with lomustine on OS in adult patients with GBM that has recurred or progressed after standard initial therapy
Secondary Objectives
To assess the effect of berubicin on progression-free survival (PFS) per Response Assessment in Neuro-Oncology (RANO) criteria in patients with GBM after failure of standard first line therapy, defined as the length of time from the initiation of study drug administration to disease progression based on MRI scan
To assess the effect of berubicin on event free survival (EFS) defined as the length of time from the initiation of study drug administration to disease progression, death, or discontinuation of treatment for any reason (eg, toxicity, intolerance, disease-related conditions, or failure to respond)
To assess the effect of berubicin on objective response rates (ORR) defined as complete and partial responses (CR + PR, respectively) as well as disease control rates (DCR) defined as CR + PR + SD per RANO criteria in adult patients with GBM after failure of standard first line therapy
To assess the safety of the recommended Phase 2 dose of berubicin given as a 2-hour IV infusion once daily for 3 consecutive days followed by 18 days off study drug (each cycle = 21 days) by the incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0
To confirm the pharmacokinetics (PK) of berubicin and its metabolite, berubicinol
Exploratory Objectives
To evaluate changes in Karnofsky Performance Status (KPS) score
To evaluate changes in patient-reported outcomes based on a qualified measurement instrument (Functional Assessment of Cancer Therapy-brain tumor specific version [FACT-Br])
To explore the effect of O[6]-methylguanine-DNA methyltransferase (MGMT) methylation status on response to berubicin between and within the two arms of the study
To evaluate re-resection with limited disease at initiation
To evaluate use of bevacizumab for edema control/steroid resistance or intolerance between the two arms of the study