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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 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01820325
The ClinicalTrials.gov registry entry for NCT01820325 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT01820325 reports 0 study locations.
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.
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