Back to search results

Study of ASTX030 (Azacitidine and Cedazuridine) for Myeloid Neoplasms

This study is testing ASTX030, a combination of cedazuridine and azacitidine, given as oral tablets or capsules. It's for people with certain blood cancers like Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). The study is comparing oral ASTX030 to azacitidine given under the skin (subcutaneous). Researchers want to see how much of the drug gets into the body and if it causes side effects. For some parts of the study, they are also looking at how many people have a complete response (meaning their cancer goes away). Some parts of this study are still enrolling new participants.

Study design
This is a multi-phase study (Phases 1-3) with different parts. Some parts compare oral ASTX030 to subcutaneous azacitidine, and some parts are randomized and open-label.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Side effects will be monitored for up to 24 months in some parts of the study. Complete response rates will be assessed for up to 36 months in other parts.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04256317

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Taiho Oncology, Inc.
~316 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:AzacitidineASTX030 (cedazuridine + azacitidine)CedazuridineVenetoclax

At a glance

Recruiting sites
65 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1, 2 and 3 Monotherapy: Total Cycle Area Under the Curve (AUC) From 0 to 24 Hours (AUC0-24) Exposures
Measured over Predose and at multiple timepoints post-dose up to 24 hours
+6 more outcomes measured

Conditions

Myelodysplastic Syndromes
Acute Myeloid Leukemia
Myelodysplastic Syndrome/Neoplasm
Chronic Myelomonocytic Leukemia

Explore related trials

Acute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic Syndrome

Where it's being run

71 sites across 41 states
Spain12
New York6
Italy6
Texas3
England3
California2
Oregon2
Prague2

Who to contact

Taiho Oncology, Inc.
[email protected]
+1 844-878-2446
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Phase 2 Monotherapy:
Phase 3 Monotherapy:
Phase 1 and Phase 2 Combination Therapy:

Exclusion

All Monotherapy Phases:
Phase 1 and Phase 2 Combination Therapy:

What this trial measures

  • Phase 1, 2 and 3 Monotherapy: Total Cycle Area Under the Curve (AUC) From 0 to 24 Hours (AUC0-24) ExposuresPredose and at multiple timepoints post-dose up to 24 hours

    Ratio of azacitidine total cycle AUC0-24 exposures after oral ASTX030 over SC azacitidine.

  • Phase 1 Combination Therapy: Number of Participants with Treatment-emergent Adverse Events (TEAEs)Up to 24 months
  • Phase 1 and 2 Combination Therapy: Complete Response (CR) Rate as Assessed by the InvestigatorUp to 36 months
  • Phase 1 Combination Therapy: AUC0-24 of Venetoclax With ASTX030Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 7 (with ASTX030] of Cycle 1
  • Phase 1 Combination Therapy: AUC0-24 of Venetoclax Without ASTX030Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 14 (without ASTX030) of Cycle 1
  • Phase 1 Combination Therapy: Maximum Plasma Concentration (Cmax) of Venetoclax With ASTX030Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 7 (with ASTX030] of Cycle 1
  • Phase 1 Combination Therapy: Cmax of Venetoclax Without ASTX030Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 14 (without ASTX030) of Cycle 1