Spots Global Cancer Trial Database for Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma
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Trial Identification
Brief Title: Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma
Official Title: A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma
Study ID: NCT05041127
Study Description
Brief Summary: 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.
Detailed Description: 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
M D Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Anthony P Conley, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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