drugset / Trial / NCT04915404
Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV)
Phase 1/2
Terminated
5 enrolled
WPD Pharmaceuticals Sp. z o.o.
National Center for Research and Development, Poland · collabWorldwide Clinical Trials · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-12-07
- Primary completion
- 2023-12-30
- Completion
- 2023-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Berubicin | Small molecule | 7.5 mg/m2 | Intravenous |