Phase II Study of Cetuximab With or Without OSI-906 in Head and Neck Squamous Cell Carcinoma (HNSCC)

Summary

The goal of this clinical research study is to learn if the addition of OSI-906 to cetuximab can improve response. The safety of these drugs will also be studied. Objectives: Primary Objective(s): To assess progression-free survival (PFS) among patients with head and neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab plus OSI-906 and compare it with PFS among patients treated with cetuximab plus placebo. Secondary Objective(s): * To assess the safety and toxicity of these treatment regimens. * To assess the efficacy of these two treatment regimens in terms of overall survival, response rate, and disease control rate * To assess the efficacy of single agent OSI-906 following cetuximab treatment in terms of response rate and disease control rate in patients who cross-over from Arm B to receive single-agent OSI-906 * To explore blood-based and tissue biomarkers

Timeline

Start

2013-06

Primary completion

2016-06

Completion

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Drugs

Indications