AG120-C-009 A Phase 3, Multicenter, Double-Blind, Randomized, Placebo Controlled Study of AG-120 in Combination with Azacitidine in Subjects = 18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation
Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult subjects with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is Overall Survival (OS). The key secondary efficacy endpoints are Event free Survival (EFS), rate of complete remission (CR), Rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Subjects eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 392 subjects will participate in the study.