Cancer Type: Head & Neck
Study Type: Treatment
Phase: Phase III
Principal Investigator: Kirtane, Kedar
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 ()
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
Back to top
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.
Moffitt Cancer Center is committed to the health and safety of our patients and their families. For more information on how we’re protecting our new and existing patients, visit our COVID-19 Info Hub
A secure website for patients to access their medical care at Moffitt.
An online resource for referring physicians and their staff.
For Moffitt faculty & staff members to access MoffittNet applications.
Our patient services specialists can assist you with scheduling an appointment, questions about medical records, insurance, billing and more.
Patient Appointment Center Hours: 7 a.m. to 7 p.m. Monday - Friday; 8 a.m. to noon Saturday