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...
Berubicin is an investigational small molecule being studied for the treatment of recurrent glioblastoma multiforme (GBM) in adults. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated in a randomized, active-controlled trial.
Berubicin targets and inhibits topoisomerase II alpha (TOP2A) and topoisomerase II beta (TOP2B). By inhibiting these enzymes, Berubicin is designed to interfere with DNA replication in cancer cells, potentially leading to cell death. This mechanism is being studied in the context of recurrent glioblastoma multiforme.
Berubicin is being developed by CNS Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CNSP. The company is conducting clinical trials to evaluate the safety and efficacy of Berubicin in adult patients with recurrent glioblastoma multiforme.
Berubicin is currently in Phase 2 clinical development. It is being studied in an active, not recruiting clinical trial for recurrent glioblastoma multiforme in adults. The drug has received Orphan Drug and Fast Track designations from the FDA, but it remains investigational and is not yet approved.
Berubicin is being evaluated in clinical trial NCT04762069, titled "A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme." This Phase 2 trial is active but not recruiting, with an enrollment of 252 participants across the United States, France, Italy, Spain, and Switzerland.
Yes, Berubicin is the same compound as CHEMBL2110580, which is a ChEMBL identifier for the drug. This identifier is used in chemical and biological databases to track the molecule. Berubicin is being developed by CNS Pharmaceuticals for the treatment of recurrent glioblastoma multiforme.