The aim of this research project is to determine whether berubicin works well, just as well or better than lomustine. Berubicin is a new investigational drug that crosses the blood-brain barrier. Lomustine is a drug that is often used to treat glioblastoma multiforme (GBM).
Aim of the study
In our research project, we want to find out whether berubicin, a new investigational drug that crosses the blood-brain barrier, works well, just as well or better than lomustine, a drug that is frequently used in GBM.
Who can take part?
Patients with glioblastoma multiforme
Procedure
If you choose to participate in our project, you will be allocated to receive berubicin or lomustine in a 2:1 ratio. If you are assigned Berubicin, you will receive the drug as an intravenous infusion (i.e. into the vein) over approximately 2 hours. If you are assigned to receive Lomustine, you will receive the medication as capsules to be taken by mouth. The treatment phase consists of treatment cycles. Each Berubicin cycle lasts 21 days (3 weeks), so you will receive Berubicin once a day for the first 3 days and no further treatment for the remaining 18 days. Each Lomustine cycle lasts 42 days (6 weeks). You will receive a single dose of Lomustine on day 1 of each treatment cycle or as a split dose on consecutive days if required.
Compensation
None
Original study name
A multicenter, open-label study with a randomized control arm on the efficacy, safety and pharmacokinetics of intravenously infused berubicin in adult patients with recurrent glioblastoma multiforme after failure of standard first-line therapy
BASEC number
2021-01974
Financial support from
CNS Pharmaceuticals