A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
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)
Sponsor: Taiho Oncology, Inc.
A observational or N/A phase clinical study on Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, this trial is actively recruiting participants. The trial is conducted by Taiho Oncology, Inc. and has accumulated 27 data snapshots since 2020. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)The Phase 1 and Phase 2 Monotherapy arms have completed enrollment. The Phase 3 Monotherapy, Phase 1 Combination Therapy, and Phase 2 Combination Therapy arms are open for enrollment.
The Phase 1 and Phase 2 Monotherapy arms have completed enrollment. The Phase 3 Monotherapy, Phase 1 Combination Therapy, and Phase 2 Combination Therapy arms are open for enrollment.
Status Flow
Change History
27 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE2/PHASE3 → None
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Mar 2026 — May 2026 [monthly]
Recruiting PHASE2/PHASE3
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Feb 2026 — Mar 2026 [monthly]
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Jan 2026 — Feb 2026 [monthly]
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Nov 2025 — Jan 2026 [monthly]
Recruiting PHASE2/PHASE3
▶ Show 22 earlier versions
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE2/PHASE3
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Sep 2025 — Oct 2025 [monthly]
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Jun 2025 — Sep 2025 [monthly]
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May 2025 — Jun 2025 [monthly]
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Apr 2025 — May 2025 [monthly]
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Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE2/PHASE3
Status: Active Not Recruiting → Recruiting
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Nov 2024 — Mar 2025 [monthly]
Active Not Recruiting PHASE2/PHASE3
Status: Recruiting → Active Not Recruiting
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Oct 2024 — Nov 2024 [monthly]
Recruiting PHASE2/PHASE3
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Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE2/PHASE3
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Aug 2024 — Sep 2024 [monthly]
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Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE2/PHASE3
Phase: PHASE2_PHASE3 → PHASE2/PHASE3
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Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE2_PHASE3
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Nov 2023 — Jun 2024 [monthly]
Recruiting PHASE2_PHASE3
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Sep 2023 — Nov 2023 [monthly]
Recruiting PHASE2_PHASE3
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Jun 2023 — Sep 2023 [monthly]
Recruiting PHASE2_PHASE3
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Dec 2022 — Jun 2023 [monthly]
Recruiting PHASE2_PHASE3
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Nov 2022 — Dec 2022 [monthly]
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May 2022 — Nov 2022 [monthly]
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Mar 2022 — May 2022 [monthly]
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Jan 2021 — Mar 2022 [monthly]
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Jun 2020 — Jan 2021 [monthly]
Recruiting PHASE2_PHASE3
Status: Not Yet Recruiting → Recruiting
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Mar 2020 — Jun 2020 [monthly]
Not Yet Recruiting PHASE2_PHASE3
First recorded
Eligibility 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.
Contact Information
- Taiho Oncology, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Atlanta, United States , Badalona, Spain , Barcelona, Spain , Barcelona, Spain , Bologna, Italy , Boston, United States , Braunschweig, Germany , Budapest, Hungary , Buffalo, United States , Charleston, United States and 61 more locations