Clinical Trial TitleA Multicenter, Open-Label Study With a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line The
National Clinical Trial Number:NCT04762069
Clinical Trial Protocol Description:
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.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a confirmed GBM diagnosis must be based on local review of tumor tissue from the initial biopsy, surgery, or re-resection. A formal pathology report confirming GBM is acceptable. It is not a requirement for slides to be sent to a central reviewer.
- Have recurrent GBM as evaluated by RANO criteria, confirmed by central review, as follows: Measurable disease is required with documented unequivocal evidence of tumor recurrence or progression following prior therapy (ie, 25% increase in the sum of the products of perpendicular diameters of the contrast-enhancing lesions while on stable or increasing doses of corticosteroids) as documented by the investigator.
You will be excluded from the study if any of the following criteria apply to you:
- Have any additional concurrent radiation therapy or chemotherapy (including but not limited to temozolomide) for recurrent or progressive GBM after a first line treatment.
- Have had prior treatment with bevacizumab.
- Have had prior treatment with lomustine.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.