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NCT01403610 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of TH-302 CNS Penetration in Recurrent High Grade Astrocytoma Following Bevacizumab
A Phase 2 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT01403610: Completed Phase 2 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT01403610 is a Phase 2 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01403610, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study 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
Primary Outcome
Time from initiation study until radiographic progression by RANO criteria
Interventions
- DRUG Placebo
- DRUG TH-302 preoperative
- DRUG TH-302 (escalating) with bevacizumab 10mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT01403610 record still lists
NCT01403610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01403610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01403610 about?
NCT01403610 is a clinical study titled "Safety and Efficacy Study of TH-302 CNS Penetration in Recurrent High Grade Astrocytoma Following Bevacizumab". 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 bevacizu...
What is the current status of trial NCT01403610?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2011-06. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01403610?
The interventions under investigation include: Placebo (DRUG), TH-302 preoperative (DRUG), TH-302 (escalating) with bevacizumab 10mg/kg (DRUG).
Who is sponsoring clinical trial NCT01403610?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01403610's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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