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

Active:	No
Cancer Type:	Head and Neck Cancer Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT04338399
Trial Phases:	Phase III	Protocol IDs:	AN2025H0301 (primary) NCI-2021-07462
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Adlai Nortye Biopharma Co., Ltd.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04338399

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.

Objectives

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.

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