A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
Key claim: An extension study continues long-term ASTX727 (oral cedazuridine plus decitabine) for patients still benefiting from prior ASTX727 trials primarily to collect long-term safety data, with a completed food-effect substudy of fed versus fasted dosing.
Abstract
Extension study to provide ongoing long-term treatment with ASTX727 for participants who were benefitting from ASTX727 treatment in a previous Taiho (formerly Astex)-sponsored clinical study of ASTX727 (including, but not limited to ASTX727-01 [NCT02103478], ASTX727-02 [NCT03306264], ASTX727-04 [NCT03813186]), ASTX727-06 [NCT04093570] food effect substudy, ASTX727-17 [NCT04953897], and ASTX727-18 [NCT04953910] to obtain long-term safety information.
The purpose of the Food Effect Substudy was to evaluate the pharmacokinetics (PK) and safety of decitabine and cedazuridine when ASTX727 was given under fed (high-calorie/high-fat meal or low-calorie/low-fat meal) versus fasted conditions. Food Effect Substudy has now completed.
Why this matters
An extension study continues long-term ASTX727 (oral cedazuridine plus decitabine) for patients still benefiting from prior ASTX727 trials primarily to collect long-term safety data, with a completed food-effect substudy of fed versus fasted dosing.