Phase II multicenter randomized, double blind, placebo controlled study assessing the efficacy of buparlisib (BKM120) plus paclitaxel vs. placebo plus paclitaxel in patients with platinum pre-treated recurrent or metastatic head and neck squamous cell carcinoma
ID Number 14-0452Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called buparlisib, when given in combination with paclitaxel to patients with metastatic squamous cell carcinoma of the head and neck. An experimental drug is not approved by the United States Food and Drug Administration (FDA) for use except in research studies. We will compare the effectiveness and safety of buparlisib plus paclitaxel with a buparlisib-matches placebo plus paclitaxel.
Recruiting Patients: Yes