Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Berubicin · 1 trial · 1 indication
To assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with GBM that has recurred or progressed after standard initial therapy
| Arm | Type | Description |
|---|---|---|
| Berubicin | EXPERIMENTAL | Berubicin intravenously infused will be administered at a dose of 7.1 mg/m2 as free base as a 2 hour intravenous (IV) infusion once daily for 3 consecutive days followed by 18 days off study drug (each cycle = 21 days) Each treatment cycle is 21 days. Subjects will be allowed to continue on treatment at the discretion of the Investigator if there is no evidence of disease progression and the subject is not experiencing unacceptable toxicity as well as if both the subject and Investigator agree that further therapy is in the subject's best interest. |
| Lomustine (CCNU, CeeNU®, or Gleostine®) capsules | ACTIVE_COMPARATOR | Lomustine (CCNU, CeeNU®, or Gleostine®) capsules will be administered at the institutionally-approved dose and regimen or per the full prescribing information/summary of product characteristics. |
| Name | Type | Description |
|---|---|---|
| Berubicin | DRUG | Berubicin HCl is a novel synthetic anthracycline with a chemical structure similar to doxorubicin HCl, a cytotoxic anthracycline topoisomerase II inhibitor isolated from cultures of Streptomyces peucetius var. caesius. |
| Lomustine | DRUG | Lomustine is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as an "alkylating agent. |
Patients will be eligible for the study if they meet all of the following inclusion criteria and none of the exclusion criteria. Inclusion criteria 1. Written informed consent from the patient or their legally authorized representative (LAR) prior to any study-related procedure, and willing and ab...