A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML


Study Number
543719
Phase
I/II
Age Group
Adult
Purpose

Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 dose to SC azacitidine. The duration of this phase 1-3 study is approximately 7 years.

Full Title

A Multi-phase, Pharmacokinetics, Safety, and Efficacy Study of ASTX030 (Azacitidine and Cedazuridine) as Monotherapy in Subjects with Myeloid Neoplasm or in Combination with Venetoclax in Subjects with AML(AZTOUND Study)

ClinicalTrials.Gov ID
NCT04256317

To inquire about participating in these studies, call 1-800-ROSWELL (1-800-767-9355) or e-mail askroswell@roswellpark.org.