Comparison of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Everfront Biotech Co., Ltd.
Study ID
NCT07349693
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Recurrent Glioblastoma, IDH-Wildtype

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cerebraca wafer — DRUG
    Cerebraca Wafer, (75 mg (Z)-n-butylidenephthalide, (Z)-BP, Implant)
  • Temozolomide (for relapsed malignant glioma) — DRUG
    TMZ as the standard-of-care (SOC) treatment for recurrent glioblastoma.

Study Details

This study is designed as a multi-center, randomized, open-label trial to evaluate the efficacy of Cerebraca Wafer in patients with recurrent glioblastoma. Cerebraca Wafer is intended for use in recurrent glioblastoma as an adjunct to surgery (followed by standard-of-care temozolomide), demonstrating potential to improve outcomes in this serious and life-threatening condition

Key Dates

Start date
Nov 1, 2026
Status verified
Jan 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2030

Study Design

Enrollment
175 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group (Cerebraca Wafer)
    Patients will receive surgical tumor resection, implantation of 6 Cerebraca Wafer (75 mg each, total dose of 450 mg (Z)-BP) at the time of surgery, followed by SOC TMZ therapy.
  • Active Comparator: Comparative Group (Standard-of-Care)
    Patients will receive surgical tumor resection, followed by SOC TMZ therapy.

Primary Outcome Measure

Median overall survival (OS) [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Legorreta Cancer Center Warren Alpert Medical School of Brown UniversityProvidenceRhode Island02903
Clark C. Chen, MD PhD FAANS
[email protected]

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By research site
Legorreta Cancer Center Warren Alpert Medical School of Brown University· Providence, RI

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