A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)

ClinicalTrials.gov ID: NCT04256317

Public ClinicalTrials.gov record NCT04256317. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04256317
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Taiho Oncology, Inc.; Industry
Enrollment: 316 participants

Conditions and interventions

Conditions

Interventions

Azacitidine Drug
ASTX030 (cedazuridine + azacitidine) Drug
Cedazuridine Drug
Venetoclax Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 21, 2020 (Actual)
Primary completion: Nov 1, 2027 (Estimated)
Completion: Nov 1, 2028 (Estimated)
Last update posted: Oct 6, 2026

2020 – 2028

United States locations

U.S. sites: 24
U.S. states: 15
U.S. cities: 21

Facility	City	State	ZIP	Site status
Keck School of Medicine of USC	Los Angeles	California	90089	Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center	Orange	California	92868	Recruiting
Yale University	New Haven	Connecticut	06510	Recruiting
University of Miami - Sylvester Comprehensive Cancer Center	Miami	Florida	33136	Recruiting
University of Emory - Winship Cancer Institute	Atlanta	Georgia	30322	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02114	Recruiting
John Theurer Cancer Center / Hackensack University	Hackensack	New Jersey	07601	Recruiting
Roswell Park Comprehensive Cancer Center	Buffalo	New York	14263	Recruiting
New York University Langone Hospital - Long Island	Mineola	New York	11501	Recruiting
Perlmutter Cancer Center - 34th Street	New York	New York	10016	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Recruiting
Weill Cornell Medical Center	New York	New York	10065	Withdrawn
Montefiore Medical Center	The Bronx	New York	10467	Recruiting
Duke University	Durham	North Carolina	27705	Recruiting
Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute	Columbus	Ohio	43210	Recruiting
Oregon Health and Science University	Portland	Oregon	97239	Recruiting
Oregon Oncology Specialists	Salem	Oregon	97301	Recruiting
Hollings Cancer Center	Charleston	South Carolina	29425	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Recruiting
Baylor Research Institute dba Baylor Scott & White Research Institute	Dallas	Texas	75204	Withdrawn
University of Texas Southwestern Medical Center	Dallas	Texas	75390	Recruiting
MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
Seattle Cancer Care Alliance	Seattle	Washington	98109	Recruiting
Froedtert & Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04256317, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 6, 2026 · Synced Oct 18, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04256317 live on ClinicalTrials.gov.

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