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NCT01487265 · ClinicalTrials.gov registry record · Phase 2
Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT01487265: Completed Phase 2 study, sponsored by SCRI Development Innovations.
NCT01487265 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01487265, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
Preclinical data in lung cancer cell lines showed that EGFR mutation can potentially be a positive predictor for sensitivity to BKM120. Furthermore, when the erlotinib-resistant model H1975 (LR858 and T790M mutation) was treated with BKM120, significant tumor control was observed (Novartis internal data). Therefore, combining BKM120 with erlotinib could potentially down-modulate PI3K-Akt activity resulting in a synergistic effect on cell growth inhibition and enhancing the response to erlotinib.
Primary Outcome
Percentage of patients who are alive and progression-free at 3 months (APF3) from first treatment.
Interventions
- DRUG BKM120 and Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2014-03 |
| Est. Completion | 2017-12-11 |
| Phase | Phase 2 |
What the finished NCT01487265 record still lists
NCT01487265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which BKM120 and Erlotinib is the first listed.
NCT01487265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01487265 about?
NCT01487265 is a clinical study titled "Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib". Preclinical data in lung cancer cell lines showed that EGFR mutation can potentially be a positive predictor for sensitivity to BKM120. Furthermore, when the erlotinib-resistant model H1975 (LR858 and T790M mutation) was treated with BKM120, significant tumor control was observed (Novartis internal ...
What is the current status of trial NCT01487265?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2014-03. Estimated completion is 2017-12-11.
What interventions are being tested in trial NCT01487265?
The interventions under investigation include: BKM120 and Erlotinib (DRUG).
Who is sponsoring clinical trial NCT01487265?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01487265's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 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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