A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) (NCT04256317)
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)
🩺 Plain-English Summary (8th-Grade Level)
Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy 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 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 Monotherapy is a randomized open-label crossover study comparing the final fixed dose of oral ASTX030 to SC azacitidine. Phase 1 Combination Therapy is an open-label, multicenter, randomized, exploratory study comparing ASTX030 and SC azacitidine in combination with venetoclax in participants with treatment-naïve AML. Phase 2 Combination Therapy is an open-label, single arm, study evaluating the efficacy, safety, pharmacokinetics (PK), and drug interactions of ASTX030 in combination with venetoclax in participants with treatment-naïve AML. The duration of this multi-phase study is approximately 8 years.
Who can join: Review the eligibility criteria below.
Location: Keck School of Medicine of USC — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (71 Sites)
Showing the first 25 of 71 sites.
- Keck School of Medicine of USC — Los Angeles, California
- UC Irvine Health - Chao Family Comprehensive Cancer Center — Orange, California
- Yale University — New Haven, Connecticut
- University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida
- University of Emory - Winship Cancer Institute — Atlanta, Georgia
- Dana-Farber Cancer Institute — Boston, Massachusetts
- John Theurer Cancer Center / Hackensack University — Hackensack, New Jersey
- Roswell Park Comprehensive Cancer Center — Buffalo, New York
- New York University Langone Hospital - Long Island — Mineola, New York
- Perlmutter Cancer Center - 34th Street — New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
- Weill Cornell Medical Center — New York, New York
- Montefiore Medical Center — The Bronx, New York
- Duke University — Durham, North Carolina
- Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute — Columbus, Ohio
- Oregon Health and Science University — Portland, Oregon
- Oregon Oncology Specialists — Salem, Oregon
- Hollings Cancer Center — Charleston, South Carolina
- Vanderbilt University Medical Center — Nashville, Tennessee
- Baylor Research Institute dba Baylor Scott & White Research Institute — Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas
- MD Anderson Cancer Center — Houston, Texas
- Seattle Cancer Care Alliance — Seattle, Washington
- Froedtert & Medical College of Wisconsin — Milwaukee, Wisconsin
- Eastern Health - Health Sciences Centre — St. John's, Newfoundland and Labrador
📞 Contact the Study Coordinator
Phone: (844) 878-2446
Email: medicalinformation@taihooncology.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.