Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-30 @ 8:51 AM
Study NCT ID:
NCT03234595
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2017-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma
Sponsor:
Everfront Biotech Co., Ltd.
Organization:
Study Overview
Official Title:
Everfront Biotech Co., Ltd.
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
* This is a first-in-human, open-label, one-arm, Phase I/IIa study to investigate the safety and efficacy of Cerebraca Wafer with adjuvant TMZ treatment in patients with recurrent high-grade glioma. Eligible participants are to receive Cerebraca Wafer implantation as well as TMZ treatment.
* Phase I is a typical dose escalation study utilizing traditional 3+3 study design. There are 4 dose levels in this stage. DLT is to be assessed during the Phase I to evaluate the safety and tolerance of Cerebraca Wafer and to determine the MTD. Data and Safety Monitoring Board (DSMB) meetings are held before dose escalation and for MTD determination.
* In Phase IIa, participants are to be enrolled for assessment of the efficacy and safety. The cavity surface after tumor removal is maximally covered by Cerebraca Wafer without exceeding the MTD defined in Phase I. Data collected from participants in Phase I receiving treatment as designed for Phase IIa are incorporated into Phase IIa to reduce the participant number. The study consists of 2 periods:
1. Main Study Period (including Screening Visit \[up to 30 days\] and Contiguous and Intermitting Visits \[overall 24 weeks\])
2. Extended Period (including Follow-up Visits \[every 8 weeks\])
* Phase I is a typical dose escalation study utilizing traditional 3+3 study design. There are 4 dose levels in this stage. DLT is to be assessed during the Phase I to evaluate the safety and tolerance of Cerebraca Wafer and to determine the MTD. Data and Safety Monitoring Board (DSMB) meetings are held before dose escalation and for MTD determination.
* In Phase IIa, participants are to be enrolled for assessment of the efficacy and safety. The cavity surface after tumor removal is maximally covered by Cerebraca Wafer without exceeding the MTD defined in Phase I. Data collected from participants in Phase I receiving treatment as designed for Phase IIa are incorporated into Phase IIa to reduce the participant number. The study consists of 2 periods:
1. Main Study Period (including Screening Visit \[up to 30 days\] and Contiguous and Intermitting Visits \[overall 24 weeks\])
2. Extended Period (including Follow-up Visits \[every 8 weeks\])
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: