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NCT01852292 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 157
- Enrollment target
NCT01852292: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01852292 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 157 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01852292, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 157 participants
- Enrollment target
Study Summary
Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.
Primary Outcome
PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression per RECIST v. 1.1 or death due to any cause. If a patient has not progressed or died at the analysis cut-off date or when the patient receives further anti-neoplastic therapy, PFS was censored on the date of the last adequate tumor assessment before the earlier of the cut-off date or start of the further anti-neoplastic therapy date.
Interventions
- DRUG Paclitaxel
- DRUG Buparlisib
- DRUG Buparlisib matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2013-10-01 |
| Est. Completion | 2017-03-30 |
| Phase | Phase 2 |
Why NCT01852292 stopped before completion
NCT01852292 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 3 interventions - of which Paclitaxel is the first listed.
NCT01852292 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01852292 about?
NCT01852292 is a clinical study titled "Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy". Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.
What is the current status of trial NCT01852292?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 157 participants. The study started on 2013-10-01. Estimated completion is 2017-03-30.
What interventions are being tested in trial NCT01852292?
The interventions under investigation include: Paclitaxel (DRUG), Buparlisib (DRUG), Buparlisib matching Placebo (DRUG).
Who is sponsoring clinical trial NCT01852292?
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 NCT01852292's enrollment target sits among peer trials
157 443rd of 2000 higher than 1,556 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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