Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy

Summary

Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.

Timeline

Start

2013-10-01

Primary completion

2017-03-30

Completion

2017-03-30

Outcome

Met primary endpoint

registry analysis (other test); Buparlisib + Paclitaxel vs Buparlisib Matching Placebo + Paclitaxel; Cox Proportional Hazard 0.646 (95% CI 0.44 to 0.94) NCT01852292 ↗

paper hazard ratio 0·65 [95% CI 0·45-0·95], nominal one-sided p=0·011. PMID 28131786 ↗

Publications

• Desilets A, Lucas J, Licitra LF, Lu S, Tse A, Tang T, Dreyer K, He N, Birgerson LE, Faivre S, Soulieres D. Buparlisib and Paclitaxel in Patients with Head and Neck Squamous Cell Carcinoma: Immunogenomic Biomarkers of Efficacy from the BERIL-1 Study. Target Oncol. 2025 Mar;20(2):299-310. doi: 10.1007/s11523-024-01126-0. Epub 2025 Jan 14.
• Soulieres D, Faivre S, Mesia R, Remenar E, Li SH, Karpenko A, Dechaphunkul A, Ochsenreither S, Kiss LA, Lin JC, Nagarkar R, Tamas L, Kim SB, Erfan J, Alyasova A, Kasper S, Barone C, Turri S, Chakravartty A, Chol M, Aimone P, Hirawat S, Licitra L. Buparlisib and paclitaxel in patients with platinum-pretreated recurrent or metastatic squamous cell carcinoma of the head and neck (BERIL-1): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Oncol. 2017 Mar;18(3):323-335. doi: 10.1016/S1470-2045(17)30064-5. Epub 2017 Jan 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buparlisib	Small molecule	100 mg	Oral
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Indications