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BRAIN: Bevacizumab +/- Irinotecan in Recurrent Glioblastoma
NCT00345163Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2006
- Primary completion
- Sep 2007
- Sponsor
- Genentech
- Modality
- Monoclonal Antibodies
- Drugs
- bevacizumab
- Conditions
- glioblastoma (GBM)
01
Overview
Phase 2, randomised, open-label trial of bevacizumab in glioblastoma (GBM) (2 arms), sponsored by Genentech. Primary endpoints: Objective Response Rate and Progression-Free Survival at 6 months. Started Jul 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Bevacizumab Alone
Bevacizumab monotherapy
Bevacizumab + Irinotecan
Bevacizumab in combination with Irinotecan
03
Who it enrols
Adult patients with histologically confirmed glioblastoma in first or second relapse, with prior radiation and chemotherapy, and no prior bevacizumab or irinotecan.
04
Endpoints
Primary
Objective Response Rate
Progression-Free Survival
Secondary
Incidence of Adverse Events
Duration of Objective Response
Overall Survival
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