Cerebraca Wafer (75 mg \[(Z)-n-butylidenephthalide\]) is designed for surgical combination to treat glioblastoma (GBM) diseases. High-grade glioma includes GBM (Grade IV, isocitrate dehydrogenase 1 \[IDH1\] wild-type) and anaplastic astrocytoma (Grade IV and Grade III, IDH1 mutation). Among these, GBM is the most common and aggressive brain tumor. Patient suffering from GBM 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 recurrent GBM patients is 6 to 9 months regardless of the use of current available therapies. The clinical trial aimed to evaluate the safety and efficacy profiles of Cerebraca Wafer plus adjuvant TMZ in patients with recurrent GBM. Additionally, the study sought to determine the maximum tolerated dose (MTD) of Cerebraca Wafers. This study specifically examined the safety of the intended dose of 6 wafers.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
To determine the maximum tolerated dose (MTD) of Cerebraca Wafer by dose limiting toxicity (DLT) in patients with recurrent high-grade glioma.
Timeframe: 2 year
To evaluate the efficacy profiles of Cerebraca Wafer in patients with recurrent high-grade glioma.
Timeframe: 2 year