Safety and Efficacy Study of TH-302 CNS Penetration in Recurrent High Grade Astrocytoma Following Bevacizumab
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio