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NCT01385293 · ClinicalTrials.gov registry record · Phase 2
BKM120 in Metastatic Castration-resistant Prostate Cancer
A Phase 2 study, sponsored by Andrew J. Armstrong, MD.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01385293: Clinical Trial Phase 2 study, sponsored by Andrew J. Armstrong, MD.
NCT01385293 is a Phase 2 study that was terminated before completion, run by Andrew J. Armstrong, MD. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01385293, a Phase 2 study, was terminated before completion, sponsored by Andrew J. Armstrong, MD.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effects of the study drug, BKM120. The study drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This protein is found in normal cells and in cancer cells, but often in many cancer cells this protein is overactive. Inhibiting the protein may slow the growth of prostate cancer but this has not been tested yet in men with prostate cancer.
Primary Outcome
Time in months from the start of study treatment to the date of first progression or death due to any cause. Progression was determined either radiographically using a composite of the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 2 (PCWG2) criteria or clinically as judged from a skeletal-related event, need for change in therapy, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last fo
Interventions
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
Why NCT01385293 stopped before completion
NCT01385293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which BKM120 is the first listed.
NCT01385293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01385293 about?
NCT01385293 is a clinical study titled "BKM120 in Metastatic Castration-resistant Prostate Cancer". The purpose of this study is to evaluate the effects of the study drug, BKM120. The study drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This protein is found in normal cells and in cancer cells, but often in many cancer cells this protein is overactive. Inh...
What is the current status of trial NCT01385293?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-08. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01385293?
The interventions under investigation include: BKM120 (DRUG).
Who is sponsoring clinical trial NCT01385293?
This trial is sponsored by Andrew J. Armstrong, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01385293's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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