A Phase I/IIa Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety and Efficacy Profile of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma.
High grade gliomas, glioblastoma multiforme (grade IV) and anaplastic anaplastic astrocytoma (Grade III), are the most comment malignant brain tumor. The cause of gliomas remains unknown. Despite of several researches on environmental hazards and genetic alterations, no direct causes were found.
Patient suffering from glioma usually develops symptoms such as headaches, seizures, memory loss and changes in behavior in its early phase. At later stages, patients may encounter loss of movement and sensation, language dysfunction and cognitive impairments depending on location and size of the tumor. The average survival of glioblastoma patients is 15 months regardless of the use of multimodal therapy.
(Z)-BP/polymer wafer, designated as Cerebraca wafer, is a biodegradable wafer for interstitial implantation comprises (Z)-n-butylidenephthalide ((Z)-BP; the active moiety) and Carboxyphenoxypropane-Sebacic Acid Copolymer (CPPSA; the excipient).
Cerebraca wafer, the first human-use drug product, is a biodegradable implant comprises (Z)-n-butylidenephthalide ((Z)-BP) and CPPSA. According to pre-clinical study, (Z)-BP could reduce glioma migration and invasion, it also could reduce the tumor stem cell marker gens.
There are a main study period and extended period in this study. Main study period Screening Day -30~-1
(1) Tumor resection and Cerebraca wafer implantation (2)Blood sampling for PK (3) Blood sampling for PD (4) Evaluation Day10~24
All patients will be followed in the Extended Period for the efficacy and safety profiles until any one of study cut-off criteria is met.
Study cut-off criteria: (Applies to phase I and IIa) (1)90% patient died or loss of follow-up (2)2 years after the last patient receives Cerebraca wafer implantation
| Condition | Recurrent Malignant Glioma, Recurrent High Grade Glioma |
|---|---|
| Treatment | Cerebraca wafer |
| Clinical Study Identifier | NCT03234595 |
| Sponsor | Everfront Biotech Co., Ltd. |
| Last Modified on | 27 January 2023 |
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