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NCT01435395 · ClinicalTrials.gov registry record · Phase 1
Trial of Temozolomide, Bevacizumab Plus Bortezomib for Recurrent Glioblastoma Multiforme
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01435395: Completed Phase 1 study, sponsored by Emory University.
NCT01435395 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01435395, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a single-center (Emory University), open-label, single arm, phase I study to assess safety and toxicity of bortezomib in combination with bevacizumab and escalating doses of temozolomide for patients with recurrent glioblastoma multiforme. Patients requiring anti-epileptic medications will have to be at least 10 days off EIAEDs. Only non-EIAEDs are accepted.
Primary Outcome
Complete or partial responses will be based upon major changes in tumor size on the Gd-MRI scan compared to the baseline scan. Determination of progressive disease is based upon comparison to the previous scan with the smallest measurements.
Interventions
- DRUG Temozolomide, bevacizumab and bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-12 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT01435395 record still lists
NCT01435395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Temozolomide, bevacizumab and bortezomib is the first listed.
NCT01435395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01435395 about?
NCT01435395 is a clinical study titled "Trial of Temozolomide, Bevacizumab Plus Bortezomib for Recurrent Glioblastoma Multiforme". This is a single-center (Emory University), open-label, single arm, phase I study to assess safety and toxicity of bortezomib in combination with bevacizumab and escalating doses of temozolomide for patients with recurrent glioblastoma multiforme. Patients requiring anti-epileptic medications will h...
What is the current status of trial NCT01435395?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2011-12. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01435395?
The interventions under investigation include: Temozolomide, bevacizumab and bortezomib (DRUG).
Who is sponsoring clinical trial NCT01435395?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01435395's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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