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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
Adlai Nortye Biopharma Co., Ltd.
Eligible participants, randomised to the experimental arm, will receive 100 mg (2 x 50 mg) buparlisib hard gel oral capsule once daily, starting on Day 1 of Treatment Cycle 1, and intravenous Paclitaxel (80 mg/m2) on Days 1, 8, and 15 of a 21-day treatment cycle. Participants randomised to the comparator arm will only receive paclitaxel. Both arms of treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason.