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Paclitaxel + Bevacizumab in Angiosarcoma
NCT01055028Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2010
- Primary completion
- Mar 2016
- Countries
- 1
- Sponsor
- Stanford University
- Modality
- Monoclonal Antibodies
- Drugs
- bevacizumab
- Conditions
- angiosarcoma
01
Overview
Phase 2, open-label trial of bevacizumab in angiosarcoma (2 arms), sponsored by Stanford University. Primary endpoint: Progression-Free Survival at 4 months. Started Feb 2010; status: terminated.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Regimen A
Paclitaxel 200 mg/m2 q3w + Bevacizumab 15 mg/kg q3w
Regimen B
Paclitaxel 90 mg/m2 weekly x3 q4w + Bevacizumab 15 mg/kg q3w
03
Who it enrols
Patients with unresectable locally advanced or metastatic angiosarcoma, ECOG 0-2, adequate organ function, and no more than 2 prior chemotherapy regimens. Excludes patients with prior taxane or bevacizumab therapy, CNS disease (unless treated), or significant vascular disease.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Response Rate
Overall Survival
Duration of Response
Adverse Events
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