drugset / Trial / NCT01055028

Paclitaxel + Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma

NCT01055028 ↗

Phase 2 Terminated 18 enrolled Stanford University Genentech, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label, single-arm, multi-center, Phase 2 study with Paclitaxel in combination with Bevacizumab in patients with Unresectable or Metastatic Angiosarcoma. The study aims to determine the safety and effectiveness of combining two drugs Paclitaxel and Bevacizumab in the treatment of Angiosarcoma that cannot be removed by surgery, or has spread to other parts of your body. The primary objective is to evaluate 4month non progression rate. The secondary objective is to evaluate overall response rate after 3rd and 6th cycle, median duration of response, 6th and 12th month survival, toxicity of Paclitaxel and Bevacizumab combination, toxicity of maintenance Bevacizumab and to collect paraffin-embedded tumor blocks for angiogenesis markers and tissue microarray.

Timeline

Start
2010-02
Primary completion
2016-03
Completion
2016-06-24

Outcome

Outcome not reported

Stopped (Enrollment): “Poor accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Paclitaxel Small molecule 90 mg/m2 Intravenous
Subject Paclitaxel Small molecule 200 mg/m2 Intravenous

Indications