Active Trials: ATN-224

Primary

• Determine the 24-week progression-free survival of ATN 224 plus temozolomide and for temozolomide alone in patients with advanced metastatic melanoma

Secondary

• Establish the safety of ATN-224 plus temozolomide in this patient population
  
  
• Establish the safety of ATN-224 as a single-agent in patients who had progression of disease while on temozolomide
  
  
• Determine the response rate, response duration, rate of stable disease for ≥24 weeks, and progression-free survival of patients treated with ATN-224 plus temozolomide and those treated with temozolomide alone.
  
  
• Determine the response rate, response duration, rate of stable disease for ≥24 weeks, and progression-free survival of patients treated with ATN-224 alone after progression following temozolomide therapy
  
  
• Determine the time to treatment failure by progression of disease or death for patients receiving ATN 224 plus temozolomide and for patients receiving temozolomide followed by ATN 224
  
  
• Determine tumor copper/zinc super oxide dismutase enzyme levels, markers of cell signaling and, for patients receiving ATN-224, molybdenum levels in pre- and post-treatment tumor samples from patients with accessible lesions who volunteer to be biopsied
  
  
• Explore the use of PET scans at pre-treatment and at 2 weeks to predict response to ATN-224