A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 20 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03234595 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1/Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Everfront Biotech Co., Ltd. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Taiwan |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Recurrent High Grade Glioma |
Contact a Trial Team
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