In this trial, patients will receive 75mg/m2 of Vidaza (azacitidine for injection) either intravenously or subcutaneously in combination with an oral dose of MGCD0103 in 28-day cycles. Key objectives for this study are to determine the overall response rate, progression-free survival and duration of response. The trial will enroll up to 75 patients at cancer centers in North America and will include a pharmacokinetic equivalency study.
Andrew Allen, Pharmion’s executive vice president and chief medical officer, said: “The biology of cancer suggests multiple epigenetic mechanisms cooperate to silence tumor suppressor genes, which raises the simple hypothesis that attacking these mechanisms with drug combinations may be superior to single-agent therapy. In this trial, we are combining Vidaza, our DNA methyltransferase inhibitor, with MGCD0103, our isotype-selective histone deacetylase inhibitor, in a clinical study of this therapeutic approach.”