Phase 1/2 CTO + Bevacizumab for Recurrent Glioma Post-Bevacizumab Failure
Summary
The primary objectives of the study are to determine the maximum tolerated dose (MTD) of Carboxyamidotriazole Orotate (CTO) when combined with standard dosing of bevacizumab among patients with recurrent malignant glioma (WHO grade III or IV) that have previously failed bevacizumab (Phase 1); to determine the activity of CTO alone in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 1); to determine the activity of CTO plus bevacizumab in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 2). This study was terminated early due to funding issues. At the time of termination, the study was still in Phase 1 and no MTD for the combination of CTO and bevacizumab had been determined for this population. Phase 2 will not proceed.
Timeline
- Start
- 2013-10
- Primary completion
- 2015-07
- Completion
- 2015-07
Outcome
Outcome not reported
Stopped (Business): “Study terminated early due to funding reasons prior to completing Phase 1”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboxyamidotriazole Orotate | Unknown | — | — |
| Background | Bevacizumab | Monoclonal antibody | 10 mg/kg | — |