drugset / Trial / NCT00611325
Phase II Avastin + Bortezomib for Patients With Recurrent Malignant Glioma
Phase 2
Completed
56 enrolled
Duke University
Genentech, Inc. · collabMillennium Pharmaceuticals, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective To estimate 6-month progression free survival probability of patients with recurrent glioblastoma multiforme treated with bortezomib plus Avastin. This efficacy assessment will be made separately among patients on enzyme-inducing anti-epileptic drugs and non enzyme-inducing anti-epileptic drugs. Secondary Objectives To evaluate safety \& tolerability of bortezomib plus Avastin among patients with recurrent malignant glioma. To evaluate radiographic response, progression free survival \& overall survival of patients with recurrent malignant glioma treated with bortezomib plus Avastin
Timeline
- Start
- 2008-05
- Primary completion
- 2009-09
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Bortezomib | Small molecule | 1.7 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 2.5 mg/m2 | Intravenous |