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NCT01629615 · ClinicalTrials.gov registry record · Phase 2
A Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer
A Phase 2 study, sponsored by SOLTI Breast Cancer Research Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01629615: Completed Phase 2 study, sponsored by SOLTI Breast Cancer Research Group.
NCT01629615 is a Phase 2 study that has completed, run by SOLTI Breast Cancer Research Group. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01629615, a Phase 2 study, has completed, sponsored by SOLTI Breast Cancer Research Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the clinical activity of BKM120 in patients with metastatic triple-negative breast cancer.
Primary Outcome
Clinical benefit rate (CBR) was defined as the percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 4 months or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is the complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (small
Interventions
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT01629615 record still lists
NCT01629615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which BKM120 is the first listed.
NCT01629615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01629615 about?
NCT01629615 is a clinical study titled "A Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer". The purpose of this study is to evaluate the clinical activity of BKM120 in patients with metastatic triple-negative breast cancer.
What is the current status of trial NCT01629615?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2012-06. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01629615?
The interventions under investigation include: BKM120 (DRUG).
Who is sponsoring clinical trial NCT01629615?
This trial is sponsored by SOLTI Breast Cancer Research Group, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01629615's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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