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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 is a Phase 3 study that has completed, run by Adlai Nortye Biopharma Co.. The registered enrollment target is 487 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04338399
The ClinicalTrials.gov registry entry for NCT04338399 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 487 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adlai Nortye Biopharma Co., which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Buparlisib & Paclitaxel is the first listed.
NCT04338399 reports 0 study locations.
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.
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