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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group (Cerebraca Wafer) | Experimental | Patients will receive surgical tumor resection, implantation of 6 Cerebraca Wafer (75 mg each, total dose of 450 mg (Z)-BP) at the time of surgery, followed by SOC TMZ therapy. |
|
| Comparative Group (Standard-of-Care) | Active Comparator | Patients will receive surgical tumor resection, followed by SOC TMZ therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebraca wafer | Drug | Cerebraca Wafer, (75 mg (Z)-n-butylidenephthalide, (Z)-BP, Implant) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median overall survival (OS) | Median overall survival (OS) in recurrent glioblastoma patients (event-based) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and Safety Profile | Number of participants with treatment-related adverse events and serious adverse events as assessed by CTCAE v5.0" | 24 months |
| Survival rate | To evaluate survival rate post resection. |
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Inclusion Criteria, subjects must meet all following criteria for study enrollment:
Subject must be aged ≥ 18, regardless of gender
Subject must have histologically confirmed glioblastoma with:
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
Subject must be deemed eligible for gross total resection of contrast-enhancing MRI-identified lesion by neurosurgeon's pre-operative assessment, according to RANO II
Subject must have Karnofsky Performance Status (KPS) ≥ 70
Subject must have recovered from prior therapy toxicities with adequate organ function:
Exclusion Criteria, subjects with any of the following will be excluded:
Histological confirmation of oligodendroglioma or mixed glioma
Presence of IDH or H3K27M mutation, or 1p19q co-deletion
MRI-identified lesion meeting any criteria:
Tumor location unsuitable for surgical resection and Cerebraca Wafer implantation in the brain areas where surgical intervention would cause significant neurological deficits
Prior bevacizumab treatment with uncontrollable tumor progression
History of other malignancy within past 5 years
Immunocompromised status or autoimmune conditions requiring systemic immunosuppressive therapy, with the following exceptions:
i. Have CD4+ T-cell counts ≥350 cells/μL ii. Are on stable anti-retroviral therapy iii. Have HIV viral load below the limit of quantification c. Patients with HBV infection are eligible if they: i. Are on appropriate suppressive anti-viral therapy prior to study enrollment ii. Have no evidence of hepatic decompensation d. Patients with history of HCV infection are eligible if they: i. Have completed curative anti-viral treatment with HCV viral load below the limit of quantification
Active, uncontrolled infection or medical condition that could compromise safety and efficacy assessment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jui Hao Lee, PhD | Contact | +886 2 2756-3796 | juihaolee@efbiotech.com | |
| Jen Wei Liu, PhD | Contact | +886 2 2756-3796 | davidliu@efbiotech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Legorreta Cancer Center Warren Alpert Medical School of Brown University | Providence | Rhode Island | 02903 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Temozolomide (for relapsed malignant glioma) | Drug | TMZ as the standard-of-care (SOC) treatment for recurrent glioblastoma. |
|
| 6, 9, 12, 18, and 24 months |
| Median progression-free survival (PFS) | To determine the median progression-free survival (PFS) in recurrent glioblastoma patients. | 24 months |
| PFS rate | To evaluate PFS rate at 6, 9, and 12 months post resection | 6, 9, and 12 months |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |