A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
Enrolling by invitation · Phase 2
Conditions studied: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes
In brief
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.
Key facts
- Study ID
- NCT04093570
- Run by
- Taiho Oncology, Inc.
- People needed
- 332
- Starts
- 2019-09-30
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Compassionate Care Research Group — Fountain Valley, California, United States
- Boca Raton Clinical Research — Plantation, Florida, United States
- The University of Chicago Medical Center — Chicago, Illinois, United States
- The Sidney Kimmel Comprehensive Cancer Center at John Hopkins — Baltimore, Maryland, United States
- Cancer and Hematology Centers for Western Michigan — Grand Rapids, Michigan, United States
- Mayo - Rochester — Rochester, Minnesota, United States
- Hackensack Medical Center - 06 FE Study — Hackensack, New Jersey, United States
- Hackensack Medical Center — Hackensack, New Jersey, United States
- Rosewell Park Cancer Institute — Buffalo, New York, United States
- Roswell Park Cancer Institute - 06 FE Study — Buffalo, New York, United States
- Gabrail Cancer Center Research - 06 FE Study — Canton, Ohio, United States
- Gabrail Cancer Center Research — Canton, Ohio, United States
- Oregon Health and Science University — Portland, Oregon, United States
- Charleston Hematology Oncology Associates — Charleston, South Carolina, United States
- Vanderbilt - Ingram Cancer Center — Nashville, Tennessee, United States
- Baylor Scott White University Medical Center — Dallas, Texas, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- May Cancer Center — San Antonio, Texas, United States
- Kadlec Clinic Hematology and Oncology — Kennewick, Washington, United States
- Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
- Erebuni Medical Center — Yerevan, Armenia
- Hematology Center After Prof. R. Yeolyan (Adult Blood Disorders) — Yerevan, Armenia
- Hematology Center After Prof. R. Yeolyan (Clinic of Adults Oncology) — Yerevan, Armenia
- National Center of Oncology Named After V.A. Fanarjyan — Yerevan, Armenia
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.