Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04256317 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 2/3
Started2020-05-21
View on ClinicalTrials.gov ↗

Amendment history

2026-04-29
Study Status, Contacts/Locations v35
Study sitesdetails revised at 2 of 71 sites
2026-04-02
Study Status, Contacts/Locations v34
Study sites73→71
2026-03-16
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v33
Primary completion date2027-05-01→2027-11-01
Completion date2028-05-01→2028-11-01
Enrollment target236→316
Study arms5→6
Eligibility criteria+112 characters
[...] with projected life expectancy of at least 12 weeks. Phase 1 and Phase 2 Combination Therapy: Has histological confirmation of newly [...] agnosed AML by World Health Organization (WHO) 2022 criteria (Phase 1) or 2016 criteria (Phase 2). Participants with projected life expectancy of at least 12 [...] azuridine or azacitidine or any of their excipients. Phase 1 and Phase 2 Combination Therapy: Has a history of MPN including myelofi [...] t remain sensitive to all-trans retinoic acid (ATRA) therapy [t(8;21) and inv(16) are excluded in Phase 2 only]. Has known active central nervous system involvement from A [...]
Secondary endpoints28 to 34 entries
Phase 1 and 2 Combination Therapy: AUC0-24 of Azacitidine, Cedazuridine and Cedazuridine-epimer Phase 1 and 2 Combination Therapy: Cmax of Azacitidine, Cedazuridine and Cedazuridine-epimer Phase 1 and 2 Combination Therapy: Tmax of Azacitidine, Cedazuridine and Cedazuridine-epimer Phase 1 and 2 Combination Therapy: AUC0-9 of Azacitidine, Cedazuridine and Cedazuridine-epimer Phase 1 and 2 Combination Therapy: AUC0-inf of Azacitidine, Cedazuridine and Cedazuridine-epimer Phase 1 and 2 Combination Therapy: CR and Complete Response with Partial Hematologic Recovery (CRh) Rate Phase 1 and 2 Combina [...] [...]
Primary endpoints7 entries, revised
Phase 1 and 2 Combination Therapy: Complete Response (CR) Rate as Assessed by the Investigator
Study description+32 characters
The Phase 1 and Phase 2 Monotherapy arms have completed enrolmentenrollment. The Phase 3 Monotherapy, Phase 1 Combination Therapy, and Phase 12 Combination Therapy arms are open for enrolmentenrollment.
2026-03-03
Study Identification, Study Status, Contacts/Locations v32
Study sitesdetails revised at 4 of 73 sites
2026-02-02
Study Status, Contacts/Locations v31
Study sitesdetails revised at 4 of 73 sites
Show 30 earlier versions
2025-12-24
Study Status, Contacts/Locations v30
Study sites72→73
2025-12-04
Study Status, Contacts/Locations v29
Study sitesdetails revised at 4 of 72 sites
2025-10-30
Study Status, Contacts/Locations v28
Study sitesdetails revised at 12 of 72 sites
2025-10-22
Study Status, Outcome Measures v27
Secondary endpoints27 to 28 entries
Phase 1 Combination Therapy: Tmax of Azacitidine, Cedazuridine and Cedazuridine-epimer
2025-10-01
Study Status, Contacts/Locations v26
Study sites69→72
2025-09-03
Study Status, Contacts/Locations v25
Study sites26→69
2025-08-01
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v24
Enrollment target235→236
Study sites24→26
Study arms4→5
InterventionsASTX030 (cedazuridine + azacitidine) (Drug), ASTX030 (cedazuridine + azacitidine) (Drug), Azacitidine (Drug), Azacitidine (Drug)…→ASTX030 (cedazuridine + azacitidine) (Drug), ASTX030 (cedazuridine + azacitidine) (Drug), Azacitidine (Drug), Azacitidine (Drug)…
Eligibility criteria+4,472 characters
Inclusion Criteria: Phase 2 Monotherapy: 1. Has Confirmed MDS, CMML, or other MDS/MPN or AML diagnosis who are candidates to receive and benefit from si [...] pprovals and/or local institution standard practice. Phase 3 Monotherapy: Has confirmed MDS or CMML and is a candidate to receive an [...] g hydroxyurea) within 4 weeks before first study treatment. Is able to swallow the number of tablets/capsules required for the treatment assignment within a 10-minute period and tolerate 4 hours of fasting. Participants with projected life expectancy of at least 12 weeks. Phase 1 Combination Therapy: Has histologic [...] [...]
Secondary endpoints15 to 27 entries
Phase 1, 2 and 3 Monotherapy: Number of Participants with Treatment-emergent Adverse Events (TEAEs) Phase 1, 2 and 3 Monotherapy: Change in Deoxyribonucleic Acid (DNA) Methylation Phase 1, 2 and 3 Monotherapy: Best Clinical ResponseCR Rate forin Participants with MDS, CMML, or MDS/Myeloproliferative Neoplasms (MPN) Phase 1, 2 and 3 Monotherapy: AML-free Survival for Participants with MDS, CMML, or MDS/MPN Phase 1, 2 and 3 Monotherapy: Duration of Response Phase 1, 2 and 3 Monotherapy: Overall Survival Phase 1, 2 and 3 Monotherapy: Time to Response Phase 1, 2 and 3 Monotherapy: Red Blood Cell ( [...] [...]
Primary endpoints1 to 7 entries
Phase 1 Combination Therapy: AUC0-24 of Venetoclax With ASTX030 Phase 1 Combination Therapy: AUC0-24 of Venetoclax Without ASTX030 Phase 1 Combination Therapy: Cmax of Venetoclax Without ASTX030 Phase 1 Combination Therapy: Complete Response (CR) Rate as Assessed by the Investigator Phase 1 Combinat [...] Phase 1, 2 and 3 Monotherapy: Total Cycle Area Under the Curve (AUC) fromFrom 0 to 24 Hours (AUC0-24) Exposures
Study description+56 characters
The Phase 1 and Phase 2 Monotherapy arms have completed enrollmentenrolment. The Phase 3 armMonotherapy isand Phase 1 Combination Therapy arms are open for enrollmentenrolment.
Study title+58 characters
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Azacitidine)Venetoclax in MDS,AML CMML,(AZTOUND or AMLStudy)
2025-04-30
Study Status, Contacts/Locations v23
Study sitesdetails revised at 5 of 24 sites
2025-03-31
Study Status, Contacts/Locations v22
Study sitesdetails revised at 7 of 24 sites
2025-02-28
Study Status, Contacts/Locations v21
Study sites21→24
2025-02-06
Active, Not Recruiting→Recruiting Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v20
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2025-12→2027-05-01
Completion date2026-04→2028-05-01
Enrollment target317→235
Study arms6→4
InterventionsASTX030 (cedazuridine + azacitidine) (Drug), Azacitidine (Drug), Cedazuridine (Drug)→ASTX030 (cedazuridine + azacitidine) (Drug), ASTX030 (cedazuridine + azacitidine) (Drug), Azacitidine (Drug), Azacitidine (Drug)…
Eligibility criteria-1,263 characters
Inclusion Criteria: Phase 2: 1. Has Confirmed MDS, CMML, MDS/MPN, or AML diagnosis who are candidates to receive and benefit from single agent azacitidine as follows and as applicable according to local country approvals and/or local institution standard practice. Phase 3: Has confirmed MDS or CMML and is a candidate to receive and benefit from single agent azacitidine as applicable according to local country approvals and/or local institution standard practice: a) French-American-British myelodysplastic syndrome subtypes: r [...] ctory anemia with excess blasts in transformation (RAEB-T), and CMML o [...] [...]
Secondary endpoints13 to 15 entries
SafetyPhase 1, 2 and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs) Phase 1, 2 and 3: Change in Deoxyribonucleic Acid (DNA) methylationMethylation Phase 1, 2 and 3: Best clinicalClinical responseResponse rateRate for participantsParticipants with MDS, CMML, or MDS/myeloproliferativeMyeloproliferative neoplasmsNeoplasms (MPN) BestPhase clinical1, response2 rateand for3: participants with AML AML-free survivalSurvival for participantsParticipants with MDS, CMML, or MDS/MPN Phase 1, 2 and 3: Duration of responseResponse Phase 1, 2 and 3: Overall survivalSurvival Phase 1, [...] [...]
Primary endpoints1 entry, revised
Phase 1, 2 and 3: Total cycleCycle areaArea underUnder the curveCurve (AUC) from 0 to 24 Hours (AUC0-24) exposuresExposures
Study description+95 characters
The Phase 1 and Phase 2 arms have completed enrollment. The Phase 3 arm is open for enrollment.
Study sites21 entries, revised
MedStar Georgetown University Hospital New York University Langone Hospital - Long Island Weill Site#Cornell 153Medical Center
2024-10-30
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v19
Trial statusRecruiting→Active, Not Recruiting
Study sites22→21
2024-09-30
Study Status, Contacts/Locations v18
Study sites22 entries, revised
Eastern Health - Health Sciences Centre - General Hospital
2024-08-30
Study Status, Contacts/Locations v17
Study sitesdetails revised at 1 of 22 sites
2024-07-31
Study Status, Contacts/Locations v16
Study sitesdetails revised at 3 of 22 sites
2024-07-09
Study Identification, Study Status, Sponsor/Collaborators v15
Lead sponsorAstex Pharmaceuticals, Inc.→Taiho Oncology, Inc.
2024-06-25
Study Status, Contacts/Locations v14
Re-verified, no change to tracked fields
2024-05-31
Study Status, Contacts/Locations v13
Study sites9→22
2024-05-03
2 amendments v11-v12
2 re-verifications since 2024-05-02, no change to tracked fields
2023-09-29
Study Status v10
Primary completion date2024-04→2025-12
Completion date2024-04→2026-04
2023-08-03
Study Status, Contacts/Locations v9
Study sites8→9
2023-04-28
Study Status, Contacts/Locations v8
Study sites7→8
2022-11-18
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 7 sites
2022-10-04
Study Status, Contacts/Locations v6
Study sites6→7
2022-04-18
Study Status, Contacts/Locations v5
Study sites5→6
2022-01-24
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v4
Primary completion date2023-04→2024-04
Completion date2023-04→2024-04
Enrollment target245→317
Eligibility criteria+38 characters
[...] em (IPSS). MDS/MPN patients including CMML according to the World Health Organization (WHO) 2016 classification are also eligible if they are candidate [...] ULN. Renal: Calculated creatinine clearance >50 mL/min/1.73 m2m^2 by Cockcroft-Gault formula or other medically acceptable fo [...] first study treatment. Able to swallow the number of tablets/capsules required for the treatment assignment within a 10-minute pe [...]
Study sitescontacts updated at 5 of 5 sites
2020-12-01
Study Status, Contacts/Locations v3
Study sites2→5
2020-05-28
Study Status, Contacts/Locations v2
Study sites1→2
2020-05-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-04→confirmed 2020-05-21
Study sites0→1
2020-02-03
Original filing
Taiho Oncology, Inc.
17 trials monitored
See 2 trials at risk
Leukemia
2,553 trials monitored
See 134 trials at risk
Acute Myeloid Leukemia (AML)
1,196 trials monitored
See 63 trials at risk
Myelodysplastic Syndromes (MDS)
685 trials monitored
See 40 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT04256317
Lead Sponsor Taiho Oncology, Inc.
Conditions Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic Syndrome/Neoplasm, Chronic Myelomonocytic Leukemia
Enrollment 316 participants
Start Date 2020-05-21
Primary Completion 2027-11-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-30