Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 2, Multicenter, International, Single Arm Study to Assess the Safety and Efficacy of Single Agent Cc-486 (Oral Azacitidine) in Previously Treated Subjects With Locally Advanced or Metastatic N
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously treated subjects with locally advanced or metastatic nasopharyngeal carcinoma having failed one to two previous regimens, including platinum-based chemotherapy. Approximately 51-55 subjects will be enrolled according to a Simon two-stage design; if the predefined activity is met (>4 responses [complete response; partial response {CR/PR}] out of the first 17 evaluable subjects based on independent radiological assessment), then the study will continue to enroll an additional 34 subjects. If < or = 4 responses out of 17 are observed, then the study enrollment will be stopped.