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NCT00116376 · ClinicalTrials.gov registry record · Phase 1
Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT00116376: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT00116376 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116376, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.
Interventions
- DRUG AEE788
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2004-01 |
| Est. Completion | 2005-11 |
| Phase | Phase 1 |
What the finished NCT00116376 record still lists
NCT00116376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which AEE788 is the first listed.
NCT00116376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116376 about?
NCT00116376 is a clinical study titled "Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)". AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, ph...
What is the current status of trial NCT00116376?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2004-01. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00116376?
The interventions under investigation include: AEE788 (DRUG).
Who is sponsoring clinical trial NCT00116376?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116376's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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