drugset / Trial / NCT01403610
Safety and Efficacy Study of TH-302 CNS Penetration in Recurrent High Grade Astrocytoma Following Bevacizumab
Non-randomizedSequentialSingle-blindTreatment
Summary
The Primary Objectives are: * To determine the extent by which TH-302 is able to penetrate the blood brain barrier and affect tumor tissue * To assess the safety of single dose TH-302 in patients with high grade glioma undergoing surgery * To assess the safety of TH-302 in combination with bevacizumab for patients with high grade glioma * To determine the MTD and DLT(s) of TH-302 in combination with bevacizumab The Secondary Objectives are: To determine the progression-free survival with or without debulking craniotomy for patients treated with combination bevacizumab and TH-302 following recurrence on single agent bevacizumab
Timeline
- Start
- 2011-06
- Primary completion
- 2015-10
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | — |
| Subject | Evofosfamide | Other / unclassified | 240 mg/m2 | — |
| Subject | Evofosfamide | Other / unclassified | 340 mg/m2 | — |
| Subject | Evofosfamide | Other / unclassified | 480 mg/m2 | — |
| Subject | Evofosfamide | Other / unclassified | 575 mg/m2 | — |
| Subject | Evofosfamide | Other / unclassified | 670 mg/m2 | — |