drugset / Trial / NCT01266031
Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma
Phase 1/2
Completed
96 enrolled
National Cancer Institute (NCI)
Baylor Health Care System · collabBrain Tumor Trials Collaborative · collabColumbia University · collabEndeavor Health · collabGenentech, Inc. · collabHenry Ford Health System · collabM.D. Anderson Cancer Center · collabMUSC Hollings Cancer Center · collabMerck Sharp & Dohme LLC · collabNorthwestern University · collabOhio State University · collabRush University Medical Center · collabTexas Oncology-Austin · collabThe Cleveland Clinic · collabUF Health Cancer Center at Orlando Health · collabUniversity of North Carolina, Chapel Hill · collabUniversity of Utah Health System · collabUniversity of Washington · collabWashington University School of Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this Phase I portion of this clinical research study is to find the highest tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with malignant gliomas. The safety of these drug combinations will also be studied. The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied.
Timeline
- Start
- 2011-07-12
- Primary completion
- 2015-06-30
- Completion
- 2017-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Vorinostat | Small molecule | 400 mg | Oral |