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NCT01339052 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma
A Phase 2 study, sponsored by Patrick Y. Wen, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT01339052: Completed Phase 2 study, sponsored by Patrick Y. Wen, MD.
NCT01339052 is a Phase 2 study that has completed, run by Patrick Y. Wen, MD. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01339052, a Phase 2 study, has completed, sponsored by Patrick Y. Wen, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
BKM120 is a newly discovered drug that has been used in other research studies. Information from those other research studies suggests that BKM120 may help to slow or stop the growth of malignant gliomas. The purpose of this study is to see how well BKM120 works in patients with malignant gliomas. Patients on this study will be treated in two groups: patients who are going to receive surgery and those who will not receive surgery. This study is trying to determine how effective BKM120 is in stopping cancer cells from growing. For patients receiving surgery the research will also try to determine if an effective level of BKM120 can penetrate the brain before surgery.
Primary Outcome
pAKT response was determined by pathologist-performed semi-quantitative IHC scoring for pAKT using previously established methods for glioblastoma (GBM) patients. Sample staining scored for intensity on a 0-2+ scale (0 none, 1+ weak positive, 2+ strong positive). Change in pAKT IHC score was the difference in score from baseline to surgery. Participants were classified into 3 groups: a reduction of staining score of one degree or more (considered a response), an increase in score and no change i
Interventions
- PROCEDURE Surgery
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2011-09 |
| Est. Completion | 2019-02 |
| Phase | Phase 2 |
What the finished NCT01339052 record still lists
NCT01339052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Surgery is the first listed.
NCT01339052 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01339052 about?
NCT01339052 is a clinical study titled "Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma". BKM120 is a newly discovered drug that has been used in other research studies. Information from those other research studies suggests that BKM120 may help to slow or stop the growth of malignant gliomas. The purpose of this study is to see how well BKM120 works in patients with malignant gliomas. P...
What is the current status of trial NCT01339052?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2011-09. Estimated completion is 2019-02.
What interventions are being tested in trial NCT01339052?
The interventions under investigation include: Surgery (PROCEDURE), BKM120 (DRUG).
Who is sponsoring clinical trial NCT01339052?
This trial is sponsored by Patrick Y. Wen, MD, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01339052's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 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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