NCT03234595

A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma

Everfront Biotech Co., Ltd.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Everfront Biotech Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

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 \[every 8 weeks\])

Conditions

• Recurrent GBM

Interventions

Type	Name	Description
DRUG	Cerebraca wafer	Eligible patients will receive Cerebraca wafer implantation with adjuvant temozolomide (TMZ) for the safety and efficacy in this study. At Phase I, the MTD will be determined by DLT. At Phase IIa, up to 12 evaluable patients will be enrolled for the efficacy and safety of Cerebraca wafer implantation. At Phase IIa, the cavity surface after tumor removal will be maximally covered by Cerebraca wafer without exceeding the MTD defined at Phase I. Patients in Phase I receive treatment as designed for Phase IIa, the data will be incorporated into Phase IIa to reduce the patient number. The overall patient number in this study is therefore between 2 to 36 evaluable patients.

Timeline

• Start date: 2017-11-01
• Primary completion: 2023-04-30
• Completion: 2024-09-03
• First posted: 2017-07-31
• Last updated: 2024-09-19

Locations

3 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study