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NCT01820325 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01820325: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01820325 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01820325, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The Phase Ib part of the study aimed to determine the maximum tolerated dose/recommended Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC. The purpose of the Phase II portion of the study was to assess the treatment effect of adding buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and paclitaxel on progression free survival (PFS) in patients with previously untreated metastatic squamous NSCLC.
Primary Outcome
Determine the MTD and/or RP2D of daily buparlisib in combination with paclitaxel and carboplatin in patients with advanced or metastatic squamous NSCLC.
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Buparlisib
- DRUG Buparlisib placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-09-09 |
| Est. Completion | 2014-06-18 |
| Phase | Phase 1 |
Why NCT01820325 stopped before completion
NCT01820325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT01820325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01820325 about?
NCT01820325 is a clinical study titled "Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer". The Phase Ib part of the study aimed to determine the maximum tolerated dose/recommended Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC. The purpose of the Phase II por...
What is the current status of trial NCT01820325?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-09-09. Estimated completion is 2014-06-18.
What interventions are being tested in trial NCT01820325?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Buparlisib (DRUG), Buparlisib placebo (DRUG).
Who is sponsoring clinical trial NCT01820325?
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 NCT01820325's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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