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NCT00458601 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
A Phase 2 study, sponsored by Celldex Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT00458601: Completed Phase 2 study, sponsored by Celldex Therapeutics.
NCT00458601 is a Phase 2 study that has completed, run by Celldex Therapeutics. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00458601, a Phase 2 study, has completed, sponsored by Celldex Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study Summary
This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.
Interventions
- DRUG Temozolomide
- DRUG CDX-110 with GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2007-08 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT00458601 record still lists
NCT00458601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Temozolomide is the first listed.
NCT00458601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00458601 about?
NCT00458601 is a clinical study titled "Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme". This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be me...
What is the current status of trial NCT00458601?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2007-08. Estimated completion is 2016-05.
What interventions are being tested in trial NCT00458601?
The interventions under investigation include: Temozolomide (DRUG), CDX-110 with GM-CSF (DRUG).
Who is sponsoring clinical trial NCT00458601?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00458601's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 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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