Chordoma Clinical Trial
Official title:
A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma
This is a multicenter, single arm, phase 2 study designed to evaluate the efficacy and safety of cetuximab for the treatment of advanced (unresectable)/metastatic, chordoma. The target patient population will be any chordoma patient 18 years of age with locally unresectable disease or metastatic disease.
Primary Objective: • To evaluate the efficacy of cetuximab in patients with advanced (unresectable) or metastatic, chordoma based on response rate according to RECIST1.1. Secondary Objectives: - To evaluate response rate according to Choi criteria - To evaluate the safety and tolerability of cetuximab for chordoma patients - To evaluate the progression-free survival (median, at 24 weeks, and 52 weeks) and to determine the overall survival (median). - To evaluate the ratio of PFS on study compared to PFS from prior treatment ;
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