CNS201 - A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme

This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Approximately 210 patients with Glioblastoma Multiforme (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 overall survival

In this research study, an investigational medication named berubicin is being compared to lomustine (an approved chemotherapy medication) for the treatment of recurrent GBM. 

The main purpose of this study is to investigate how effective berubicin is in treating GBM that has recurred after initial standard therapy, and comparing this with lomustine.  The study also aims to assess the safety of berubicin and how it is absorbed by and cleared from the body.  Both medications are designed to slow or stop the growth of cancer cells.

Inclusion Criteria

• A diagnosis of Glioblastoma Multiforme (GBM)(WHO Grade IV)
• Recurrent GBM as evaluated by RANO criteria, confirmed by central review
• No more than 1 prior line of treatment (eg, surgery followed by radiation with concomitant chemotherapy, followed by adjuvant chemotherapy is considered as 1 line of treatment). A second debulking surgery during the first line treatment is acceptable.

Exclusion Criteria

• Unable or not willing to comply with the protocol regulations.
• Any additional concurrent radiation therapy or chemotherapy (including but not limited to temozolomide) for recurrent or progressive GBM after a first line treatment.
• Prior treatment with bevacizumab.

Study Requirements

Participation in this study will be at least 2 ½ years. This will include:

• A Screening Period of up to 4 weeks (to confirm that participants are suitable for the study)
• A Treatment Period -
  • oof at least 3 weeks (1 treatment cycle) – for those assigned to berubicin
  • oof at least 6 weeks (1 treatment cycle) – for those assigned to lomustine
• An End-of-Treatment Visit (to check participants overall health)
  • 4 weeks after the last dose– for those assigned to berubicin
  • 6 weeks after the last dose– for those assigned to lomustine
• A Post-study Follow-up Period of up to about 2 years after the End-of-Treatment Visit (visits will be every 6 months) to check participants overall health

During the Treatment Period, those assigned to berubicin will receive the medication via an intravenous (IV) infusion (ie, into the vein), over 2 hours.  Those assigned to lomustine will receive the medication as tablets, to be taken orally.

The Treatment Period consists of treatment ‘cycles’. Each berubicin cycle is 21 days (3 weeks), so participants will receive berubicin once a day for the first 3 days and no additional treatment for the remaining 18 days.  Each lomustine cycle is 42 days (6 weeks), so participants will receive a single dose of lomustine on Day 1 of each treatment cycle or as a divided dose over consective days, if needed.  This period will be important to demonstrate safety of each medication in this study.