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.
Berubicin is one of the first anthracyclines that crosses the blood brain barrier and
overcomes drug resistance (i.e. it is not a substrate for multi-drug resistant/breast cancer
resistant transporters). A Phase 1 clinical trial of berubicin in patients with primary CNS
malignancies demonstrated a durable response (one subject alive 13+ years) as well as stable
disease in heavily pretreated patients. Therefore, this phase 2 study is designed to further
evaluate Berubicin's activity in patients with rGBM after treatment with standard of care.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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