The BURAN Study in patients with head and neck cancer
Research type
Research Study
Full 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
IRAS ID
295731
Contact name
Derek Grose
Contact email
Sponsor organisation
Adlai Nortye USA Inc.,
Eudract number
2019-000790-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
This is a global, multicentre, randomised, open-label phase 3 study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with head and neck squamous cell carcinoma (HNSCC) who did not respond to previous treatments or for whom disease that has returned or spread and progressed after prior immunotherapy with or without prior platinum-based chemotherapy. Participants will be stratified according to historical HPV (Human papilloma virus) status.\n\nThis is a global study at 58 study sites located around 18 countries predominantly in North America, Europe, and Asia Pacific region. The primary objective of this study is to assess the overall survival (OS) of buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with refractory, recurrent, or metastatic HNSCC. Eligible participants will be randomised in a 2:1 ratio to receive either daily buparlisib in combination with weekly paclitaxel (322 patients) or weekly paclitaxel alone (161 patients) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason (e.g., withdrawal of consent, start of a new cancer therapy or at the discretion of the Investigator). The study plans to have about 483 participants take part. \n\nThe study will be divided into 3 periods, screening, treatment and follow-up period (which includes the Long-term Survival Follow-up). Participants will receive 15 cycles of treatment. Participants will be in the study approximately for 5 years. After the end of the study participants will continue to receive study drug until it is no longer benefiting participants, or participants experiences any unacceptable side effects or participants withdraw consent. From this point onwards, when participants stop the buparlisib, they will be followed by study doctor and study staff. Standard safety evaluations will be conducted at study visits.\n
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0068
Date of REC Opinion
26 May 2021
REC opinion
Further Information Favourable Opinion