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Disulfiram/Copper with RT and TMZ in Glioblastoma
NCT02715609Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2016
- Primary completion
- May 2024
- Countries
- 1
- Sponsor
- Washington University School of Medicine
- Modality
- Small Molecules
- Drugs
- disulfiram
- Conditions
- glioblastoma multiforme (GBM)
01
Overview
Phase 2, open-label trial of disulfiram in glioblastoma multiforme (GBM) (3 arms), sponsored by Washington University School of Medicine. Primary endpoints: Maximum Tolerated Dose at 28 weeks and Overall Survival at 5 years. Started Jun 2016; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Dose Level 2
Disulfiram 250mg during RT
Dose Level 3
Disulfiram 375mg during RT
Expansion Cohort
Disulfiram 250mg during RT
03
Who it enrols
Adult patients with newly diagnosed GBM (or variants) eligible for standard chemoradiation. Expansion cohort requires IDH, BRAF, or NF1 mutations. Patients must abstain from alcohol.
04
Endpoints
Primary
Maximum Tolerated Dose
Overall Survival
Secondary
Adverse Events
Pharmacokinetics
Progression-Free Survival
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