Phase II Study of Cetuximab With or Without OSI-906 in Head and Neck Squamous Cell Carcinoma (HNSCC)
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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