This study is designed as a multi-center, randomized, open-label trial to evaluate the efficacy of Cerebraca Wafer in patients with recurrent glioblastoma. Cerebraca Wafer is intended for use in recurrent glioblastoma as an adjunct to surgery (followed by standard-of-care temozolomide), demonstrating potential to improve outcomes in this serious and life-threatening condition
Subject must be aged ≥ 18, regardless of gender
Completed first-line therapy including surgery plus temozolomide and radiation (concurrent temozolomide/radiation)
Current presentation being first or second recurrence only
Subject must have measurable disease preoperatively with at least one contrast-enhancing MRI-identified lesion measuring ≥ 1 cm in two perpendicular dimensions per RANO 2.0 criteria
Histological confirmation of oligodendroglioma or mixed glioma
Presence of IDH or H3K27M mutation, or 1p19q co-deletion
Multi-focal (defined as 2 non-contiguous contrast enhancement areas > 1 cm in 2 planes on fluid-attenuated inversion recovery, FLAIR or T2-weighted sequences)
Presence of diffuse subependymal or leptomeningeal dissemination
Parallel
Cerebraca wafer
DrugCerebraca Wafer, (75 mg (Z)-n-butylidenephthalide, (Z)-BP, Implant)
Temozolomide (for relapsed malignant glioma)
DrugTMZ as the standard-of-care (SOC) treatment for recurrent glioblastoma.
Median overall survival (OS)
Median overall survival (OS) in recurrent glioblastoma patients (event-based)
Tolerability and Safety Profile
Number of participants with treatment-related adverse events and serious adverse events as assessed by CTCAE v5.0"
Survival rate
To evaluate survival rate post resection.
Median progression-free survival (PFS)
To determine the median progression-free survival (PFS) in recurrent glioblastoma patients.
PFS rate
To evaluate PFS rate at 6, 9, and 12 months post resection
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
