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ADI-PEG 20 with Stupp Protocol in Newly Diagnosed GBM
NCT04587830Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Sep 2020
- Primary completion
- Feb 2027
- Countries
- 2
- Sponsor
- Polaris Group
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- Pegargiminase
- Conditions
- glioblastoma multiforme (GBM)
01
Overview
Phase 2, randomised, double-blind trial in glioblastoma multiforme (GBM) comparing ADI-PEG 20 + Stupp with Placebo + Stupp (2 arms). Primary endpoint: Overall Survival at 2.5 years. Started Sep 2020; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
ADI-PEG 20 + Stupp
Pegargiminase + RT + TMZ
Placebo + Stupp
Placebo + RT + TMZ
03
Who it enrols
Patients aged 20-75 with newly diagnosed, histologically confirmed glioblastoma (IDH-wildtype or mutant Grade 4). Must have KPS >= 60, adequate organ function, and recovered from surgery. Excludes patients with prior systemic therapy/radiation for GBM, serious infections, or other active malignancies.
04
Endpoints
Primary
Overall Survival
Secondary
Progression-Free Survival
Duration of Response
Tumor Response Rate
Safety and Tolerability
Pharmacokinetics of ADI-PEG 20
Pharmacodynamics of ADI-PEG 20
Immunogenicity of ADI-PEG 20
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