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NCT04338399 · ClinicalTrials.gov registry record · Phase 3
The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC
A Phase 3 study, sponsored by Adlai Nortye Biopharma Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 487
- Enrollment target
NCT04338399: Completed Phase 3 study, sponsored by Adlai Nortye Biopharma Co..
NCT04338399 is a Phase 3 study that has completed, run by Adlai Nortye Biopharma Co.. The registered enrollment target is 487 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04338399, a Phase 3 study, has completed, sponsored by Adlai Nortye Biopharma Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 487 participants
- Enrollment target
Study Summary
The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.
Primary Outcome
To assess the OS of buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC
Interventions
- DRUG Buparlisib & Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 487 participants |
| Start Date | 2020-12-12 |
| Est. Completion | 2025-11-02 |
| Phase | Phase 3 |
What the finished NCT04338399 record still lists
NCT04338399 is an interventional study that assigns participants to a tested intervention. The registered 487 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which Buparlisib & Paclitaxel is the first listed.
NCT04338399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04338399 about?
NCT04338399 is a clinical study titled "The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC". The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have ...
What is the current status of trial NCT04338399?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 487 participants. The study started on 2020-12-12. Estimated completion is 2025-11-02.
What interventions are being tested in trial NCT04338399?
The interventions under investigation include: Buparlisib & Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04338399?
This trial is sponsored by Adlai Nortye Biopharma Co., which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04338399's enrollment target sits among peer trials
487 786th of 2000 higher than 1,212 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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