Ignite Creation Date:
2024-05-05 @ 11:44 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01403610
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2011-07-22
Brief Title:
Safety and Efficacy Study of TH-302 CNS Penetration in Recurrent High Grade Astrocytoma Following Bevacizumab
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase 2 Investigator Initiated Study to Determine the Safety Efficacy and CNS Penetration of TH-302 in Recurrent High Grade Astrocytoma Following Bevacizumab
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 DLTs 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
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 DLTs 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
Detailed Description:
Single center dose-escalation prospective study with TH-302 single dose at 575 mgm2 or placebo administered preoperatively followed by postoperative combination therapy bevacizumab at 10mgkg every 2 weeks and TH-302 at 240 - 670 mgm2 every 2 weeks 4 week cycle until disease progression Subjects will be randomized 21 to receive pre-operative dose of TH-302 surgical subjects only Subjects not receiving surgery will receive combination therapy of bevacizumab at 10 mgkg every 2 weeks and TH-302 at 240-670 mgm2 every 2 weeks 4 week cycle starting from Cycle 1 Day 1 until disease progression
This study will use a classic dose escalation design to determine the MTD of TH-302 when used in combination with bevacizumab The dose of TH-302 will be escalated in cohorts of 3-6 subjects The initial dose of TH-302 will be 240 mgm2 A dose level minus 1 will be built into the study in the event that subjects experience excessive toxicity at Dose Level 1 Dose escalation will continue to 340 mgm2 and 670 mgm2
This study will use a classic dose escalation design to determine the MTD of TH-302 when used in combination with bevacizumab The dose of TH-302 will be escalated in cohorts of 3-6 subjects The initial dose of TH-302 will be 240 mgm2 A dose level minus 1 will be built into the study in the event that subjects experience excessive toxicity at Dose Level 1 Dose escalation will continue to 340 mgm2 and 670 mgm2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTRC 11-24 | OTHER | The Cancer Therapy and Research Center CTRC | None |