Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV)
Status:
Not yet recruiting
Trial end date:
2025-01-31
Target enrollment:
Participant gender:
Summary
This is a multicenter, open-label, Phase 1b/2 efficacy and safety study of Berubicin
utilizing a Simon's 2-stage design to confirm the efficacy (or futility) of a single arm of
Berubicin treatment, administered at the recommended Phase 2 dose (RP2D) identified in Phase
1 studies (7.5 mg/m2 Berubicin HCl), on the endpoint of ORR in up to approximately 61
patients. A central reader will determine the radiologic responses for each patient according
to m RANO criteria. The responder criteria for this Simon's design will be based on objective
response criteria defined as individual patients achieving CR or PR per m-RANO criteria
within 6 months from baseline.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
WPD Pharmaceuticals Sp. z o.o.
Collaborators:
National Center for Research and Development, Poland Worldwide Clinical Trials