At a glance
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A Biomarker Driven Pilot Study of the Pan-class I PI3K Inhibitor NVP-BKM120 in Combination With Cetuximab in Patients With Recurrent/Metastatic Head and Neck Cancer
In Brief
A Phase 2 clinical trial evaluating PI3K inhibitor BKM120 and cetuximab for Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma and 35 related conditions. Completed, enrolled 12 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
Given PO
Given IV