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The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC — BURAN  

Head and Neck Cancer Clinical Trial

Official title:
The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Clinical Trial 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.

Clinical Trial Description

This study is to assess the impact on overall survival of the combination of Buparlisib and paclitaxel compared to paclitaxel alone in patients with 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04338399
Study type Interventional
Source Adlai Nortye Biopharma Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 12, 2020
Completion date June 30, 2026
View Details
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