drugset / Trial / NCT01816984

PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

NCT01816984

NaSingle-groupOpen-labelTreatment

Summary

This pilot randomized phase I/II trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with cetuximab and to see how well it works in treating patients with recurrent or metastatic head and neck cancer. PI3K inhibitor BKM120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving PI3K inhibitor BKM120 together with cetuximab may kill more tumor cells

Timeline

Start
2013-05
Primary completion
2018-04
Completion
2020-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Buparlisib Small molecule 80 mg Oral
Subject Buparlisib Small molecule 100 mg Oral
Subject Cetuximab Monoclonal antibody 500 mg Intravenous