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
Primary Objectives The primary objective of this study is to assess the OS of buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC. Secondary Objectives * To evaluate additional efficacy parameters including progression free survival (PFS), overall response rate (ORR), and duration of response (DoR) by the Investigator and Independent Radiological Review Committee (IRRC). * To evaluate efficacy parameters in subgroups of patients defined by the randomization strata. * To assess the effect of buparlisib in combination with paclitaxel on patient s symptoms and healthrelated quality of life (HRQoL). * To assess biomarkers of response to buparlisib in combination with paclitaxel. * To assess the pharmacokinetics (PK) of buparlisib in combination with paclitaxel.
Chemotherapy (NOS); Therapy (NOS)
BKM120 (Buparlisib); Buparlisib (); Taxol (paclitaxel); paclitaxel ()
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