NCT04338399

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 487 (actual)
• Sponsor: Adlai Nortye Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Buparlisib & Paclitaxel	Investigation drug plus paclitaxel

Timeline

• Start date: 2020-12-12
• Primary completion: 2025-11-02
• Completion: 2025-11-02
• First posted: 2020-04-08
• Last updated: 2025-11-17

Locations

162 sites across 17 countries: United States, Argentina, Australia, Belgium, Canada, China, France, Germany, Hong Kong, Hungary, Italy, Japan, Poland, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study