Date: 2015-10-25
Type of information: Initiation of preclinical development
phase: 2
Announcement:
Company: Celgene (USA - NJ)
Product: azacitidine
Action
mechanism: Azacitidine is a pyrimidine nucleoside analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily intoRNA.
Disease: nasopharyngeal neoplasms
Therapeutic area: Cancer - Oncology - Rare diseases
Country: Canada, France, Greece, Hong Kong, Italy, Romania, Singapore, Spain, Taiwan, Tunisia, USA
Trial
details: 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. (NCT02269943)
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