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Repeated Intraarterial Bevacizumab for Relapsed/Refractory GBM and AA
NCT01269853Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2010
- Primary completion
- Oct 2028
- Countries
- 1
- Sponsor
- Northwell Health
- Modality
- Monoclonal Antibodies
- Drugs
- bevacizumab
- Conditions
- glioblastoma multiforme (GBM)anaplastic astrocytoma (AA)anaplastic oligoastrocytoma (AOA)
01
Overview
Phase 2, open-label trial of bevacizumab in glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) and anaplastic oligoastrocytoma (AOA) (2 arms), sponsored by Northwell Health. Primary endpoints: Composite Overall Response Rate at 6 months, Progression-Free Survival at 6 months and 1 more. Started Oct 2010; status: recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Arm 1 (Multifocal/Leptomeningeal Disease)
IA Bevacizumab + IV Bevacizumab
Arm 2 (No Multifocal/Leptomeningeal Disease)
IA Bevacizumab only
03
Who it enrols
Adult patients with relapsed/refractory GBM, AA, or AOA, KPS >= 70, and <= 2 prior cycles of bevacizumab.
04
Endpoints
Primary
Composite Overall Response Rate
Progression-Free Survival
Overall Survival
Secondary
Safety of repeated SIACI of mannitol and Bevacizumab
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