drugset / Trial / NCT04338399

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

NCT04338399

Phase 3 Completed 487 enrolled Adlai Nortye Biopharma Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-12-12
Primary completion
2025-11-02
Completion
2025-11-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Buparlisib Small molecule 100 mg Oral
Comparator Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications