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A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
NCT04256317 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG ASTX030 (cedazuridine + azacitidine)
- DRUG Cedazuridine
Study Locations (20)
New York
- Roswell Park Comprehensive Cancer Center — Buffalo
- New York University Langone Hospital - Long Island — Mineola
- Perlmutter Cancer Center - 34th Street — New York
- Icahn School of Medicine at Mount Sinai — New York
- Weill Cornell Medical Center — New York
- University of Rochester - Wilmot Cancer Center — Rochester
- Montefiore Medical Center — The Bronx
California
- Keck School of Medicine of USC — Los Angeles
- UC Irvine Health - Chao Family Comprehensive Cancer Center — Orange
Oregon
- Oregon Health and Science University — Portland
- Oregon Oncology Specialists — Salem
Connecticut
- Yale University — New Haven
Florida
- University of Miami - Sylvester Comprehensive Cancer Center — Miami
Georgia
- University of Emory - Winship Cancer Institute — Atlanta
Massachusetts
- Dana-Farber Cancer Institute — Boston
New Jersey
- John Theurer Cancer Center / Hackensack University — Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2020-05-21 |
| Est. Completion | 2028-11-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04256317
The ClinicalTrials.gov registry entry for NCT04256317 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 46 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Azacitidine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04256317 reports 20 study locations spanning 12 distinct geographic areas — top geographies include New York, California, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04256317 about?
NCT04256317 is a clinical study titled "A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)". 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 (on...
What is the current status of trial NCT04256317?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 316 participants. The study started on 2020-05-21. Estimated completion is 2028-11-01.
What conditions does trial NCT04256317 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome/Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04256317?
The interventions under investigation include: Azacitidine (DRUG), ASTX030 (cedazuridine + azacitidine) (DRUG), Cedazuridine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04256317?
This trial is sponsored by Taiho Oncology, which has 46 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04256317 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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