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NCT01137604 · ClinicalTrials.gov registry record · Phase 2
A Study in Subjects With Recurrent Malignant Glioma
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
NCT01137604: Completed Phase 2 study, sponsored by Eisai.
NCT01137604 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 151 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01137604, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
Study Summary
An open-label phase 2, multicenter study in participants with recurrent malignant glioma.
Primary Outcome
PFS at Month 6 was defined as the percentage of participants who remained alive and progression-free at Month 6, based on investigator's assessment. Progression was defined using Response Assessment in Neuro-Oncology (RANO) criteria, as a greater than 25% increase in enhancing lesions despite stable or increasing steroid dose, an increase (significant) in non-enhancing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) lesions that are not attributable to other non-tumor causes, and any
Interventions
- DRUG Bevacizumab
- DRUG Lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2010-11-09 |
| Est. Completion | 2014-10-28 |
| Phase | Phase 2 |
What the finished NCT01137604 record still lists
NCT01137604 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT01137604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01137604 about?
NCT01137604 is a clinical study titled "A Study in Subjects With Recurrent Malignant Glioma". An open-label phase 2, multicenter study in participants with recurrent malignant glioma.
What is the current status of trial NCT01137604?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2010-11-09. Estimated completion is 2014-10-28.
What interventions are being tested in trial NCT01137604?
The interventions under investigation include: Bevacizumab (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT01137604?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01137604's enrollment target sits among peer trials
151 454th of 2000 higher than 1,546 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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