cedazuridine/azacitidine (ASTX030)

P2/3, N=317, Active, not recruiting, Taiho Oncology, Inc. | Recruiting --> Active, not recruiting

P1, N=40, Recruiting, Otsuka Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 --> May 2025 | Trial primary completion date: Nov 2024 --> Apr 2025

Following the approval of the cedazuridine/decitabine combination, ASTX727, as well as development of an oral formulation of azacitidine, CC-486, in the USA in 2020, these agents could gradually replace their injectable counterparts...However, their FDA-approved indications at this point are narrow and efficacy needs to be shown in clinical trials before considering use beyond the approved indications. Areas of special interest include; identification of predictive biomarkers for clinical benefit, post-transplant maintenance therapy, and potential combination therapies with other oral agents such as venetoclax, IDH and FLT3 inhibitors.