Actively Recruiting
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
Led by Taiho Oncology, Inc. · Updated on 2026-04-30
316
Participants Needed
71
Research Sites
440 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Phase 2 Monotherapy: Confirmed diagnosis of MDS, CMML, or other MDS/MPN and candidates for single agent azacitidine
- Phase 3 Monotherapy: Confirmed MDS or CMML with specific subtypes or risk levels, ECOG performance status 0 to 1
- Adequate organ function
- No evidence of graft-versus-host disease if prior allogeneic stem cell transplant
- No major surgery within 3 weeks before first study treatment
- No cytotoxic chemotherapy (excluding hydroxyurea) within 4 weeks before first study treatment
- Able to swallow required tablets/capsules within 10 minutes and tolerate 4 hours fasting
- Projected life expectancy of at least 12 weeks
- Phase 1 and Phase 2 Combination Therapy: Newly diagnosed AML confirmed by WHO criteria
- Projected life expectancy of at least 12 weeks
- Considered ineligible for intensive induction chemotherapy based on age or comorbidities
- ECOG Performance Status 0-2 for participants 75 years or older or 0-3 for participants 18 to 74 years old
You will not qualify if you...
- Active uncontrolled gastric or duodenal ulcer
- Poor medical risk from other conditions
- Known HIV infection
- Positive for Hepatitis B or C infection
- Life-threatening illness
- History of other malignancies except certain treated and controlled cancers
- Clinical extramedullary disease such as palpable hepatomegaly or splenomegaly in MDS/MPN including CMML
- Previous treatment with more than 1 cycle of decitabine, azacitidine, or guadecitabine (Phases 2 and 3 only)
- Recent investigational drug or therapy treatment within 2 weeks or ongoing significant adverse events from prior investigational treatments
- Known or suspected hypersensitivity to cedazuridine or azacitidine or their excipients
- Unable to discontinue drugs that delay gastric emptying such as GLP-1 or GIP agonists in Cycles 1 and 2
- History of certain myeloproliferative neoplasms or AML with BCR-ABL1 translocation (Combination Therapy)
- Specific karyotype abnormalities including t(15;17) or other acute promyelocytic leukemia variants (Combination Therapy)
- Active central nervous system involvement from AML (Combination Therapy)
- Severe hepatic or renal impairment (Combination Therapy)
- Malabsorption syndrome or other conditions preventing oral administration (Combination Therapy)
- Cardiovascular disability NYHA Class >2 (Combination Therapy)
- Significant history of various serious diseases affecting participation (Combination Therapy)
- Clinically significant uncontrolled infections (Combination Therapy)
- White blood cell count >25,000/μL (Combination Therapy)
- Prior treatment with hypomethylating agents, venetoclax, CAR-T therapy, or investigational therapies for MDS or AML (Combination Therapy)
- Cannot discontinue certain medications affecting CYP3A or P-gp enzymes prior to study start (Combination Therapy)
- Participation in another research study involving drug therapy or procedures (Combination Therapy)
- Known hypersensitivity to cedazuridine, azacitidine, venetoclax, or their excipients (Combination Therapy)
- Significant mental illness or substance abuse
- Consumption of grapefruit, Seville oranges, or starfruit within 7 days prior to study start
AI-Screening
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Trial Site Locations
Total: 71 locations
1
Keck School of Medicine of USC
Los Angeles, California, United States, 90089
Actively Recruiting
2
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
5
University of Emory - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
John Theurer Cancer Center / Hackensack University
Hackensack, New Jersey, United States, 07601
Actively Recruiting
8
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
9
New York University Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
10
Perlmutter Cancer Center - 34th Street
New York, New York, United States, 10016
Actively Recruiting
11
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
12
Weill Cornell Medical Center
New York, New York, United States, 10065
Withdrawn
13
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
14
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
15
Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
16
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
17
Oregon Oncology Specialists
Salem, Oregon, United States, 97301
Actively Recruiting
18
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
19
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
20
Baylor Research Institute dba Baylor Scott & White Research Institute
Dallas, Texas, United States, 75204
Withdrawn
21
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
22
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
23
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Actively Recruiting
24
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
25
Eastern Health - Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Actively Recruiting
26
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Actively Recruiting
27
Fakultni Nemocnice Ostrava
Ostrava, Moravian-Silesian, Czechia, 708 52
Actively Recruiting
28
Fakultní Nemocnice Královské Vinohrady
Prague, Prague, Czechia, 100 34
Actively Recruiting
29
Vseobecna Fakultni Nemocnice v Praze
Prague, Prague, Czechia, 128 08
Actively Recruiting
30
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
Toulouse, Haute-Garonne, France, 31059
Actively Recruiting
31
Hôpital l'Archet
Nice, Provence-Alpes-Côte d'Azur Region, France, 06202
Actively Recruiting
32
Hôpital Saint-Louis
Paris, Île-de-France Region, France, 75010
Actively Recruiting
33
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
34
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Not Yet Recruiting
35
Städtisches Klinikum Braunschweig
Braunschweig, Lower Saxony, Germany, 38114
Actively Recruiting
36
Universitätsklinikum Halle
Halle, Saxony-Anhalt, Germany, 06120
Actively Recruiting
37
Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati Klinika és Kardiológiai Központ
Szeged, Csongrád megye, Hungary, 6725
Not Yet Recruiting
38
Petz Aladár Győr-Moson-Sopron Vármegyei Egyetemi Oktató Kórház
Győr, Győr-Moson-Sopron, Hungary, 9023
Actively Recruiting
39
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, Hungary, 4032
Actively Recruiting
40
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
Budapest, Hungary, 1088
Actively Recruiting
41
Ospedale Santa Maria delle Croci di Ravenna
Ravenna, Emilia-Romagna, Italy, 48121
Actively Recruiting
42
Azienda Ospedaliero - Universitaria Careggi
Florence, Florence, Italy, 50134
Actively Recruiting
43
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Turin, Italy, 10128
Actively Recruiting
44
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna, Italy, 40138
Actively Recruiting
45
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
46
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy, 28100
Actively Recruiting
47
Fondazione PTV - Policlinico Tor Vergata
Roma, Italy, 00133
Actively Recruiting
48
Umberto I - Policlinico di Roma
Roma, Italy, 00161
Actively Recruiting
49
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Actively Recruiting
50
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Lublin Voivodeship, Poland, 20-081
Actively Recruiting
51
Wojewódzkie Wielospecjalistyczne Centrum
Lodz, Lódzkie, Poland, 93-513
Actively Recruiting
52
Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
Gdynia, Pomeranian Voivodeship, Poland, 81-519
Actively Recruiting
53
Institut Català d'Oncologia Badalona
Badalona, Barcelona, Spain, 08916
Actively Recruiting
54
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
55
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, Spain, 31008
Actively Recruiting
56
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Not Yet Recruiting
57
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Actively Recruiting
58
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
59
Hospital San Pedro de Alcantara
Cáceres, Spain, 10003
Actively Recruiting
60
Institut Català d'Oncologia Girona (ICO Girona)
Girona, Spain, 17007
Actively Recruiting
61
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Actively Recruiting
62
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
63
Clínica Universidad de Navarra - Madrid
Madrid, Spain, 28027
Actively Recruiting
64
MD Anderson Cancer Center Madrid
Madrid, Spain, 28033
Actively Recruiting
65
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
66
Hospital Quirónsalud Málaga
Málaga, Spain, 29004
Actively Recruiting
67
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, Spain, 37007
Actively Recruiting
68
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Actively Recruiting
69
King's College Hospital NHS Foundation Trust
London, England, United Kingdom, SE5 9RS
Actively Recruiting
70
The Christie NHS Foundation Trust
Manchester, England, United Kingdom, M20 4GJ
Actively Recruiting
71
University Hospital Southampton NHS Foundation Trust
Southampton, England, United Kingdom, SO16 6YD
Not Yet Recruiting
Research Team
T
Taiho Oncology, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
6
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