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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 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 37 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01487265
The ClinicalTrials.gov registry entry for NCT01487265 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BKM120 and Erlotinib is the first listed.
NCT01487265 reports 0 study locations.
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.
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