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NCT01297491 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT01297491: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01297491 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01297491, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.
Primary Outcome
PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a "success" for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate \<50% at 12 weeks was observed. No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the da
Interventions
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT01297491 record still lists
NCT01297491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which BKM120 is the first listed.
NCT01297491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01297491 about?
NCT01297491 is a clinical study titled "Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer". The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups...
What is the current status of trial NCT01297491?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2011-05. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01297491?
The interventions under investigation include: BKM120 (DRUG).
Who is sponsoring clinical trial NCT01297491?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01297491's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 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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