A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony zespół mielodysplazji, przewlekła białaczka mielomonocytowa lub pokrewne choroby krwi
- •Pacjent powinien być kandydatem do leczenia azacytydyną
- •Dobry stan ogólny pacjenta (ECOG 0-1)
- •Prawidłowe funkcjonowanie narządów wewnętrznych
- •Dla pacjentów po przeszczepieniu szpiku: bez objawów choroby przeszczepu
- •Brak chemioterapii w ostatnie 4 tygodnie (oprócz hydroksyurei)
- •Zdolność połykania tabletek i tolerowanie 4 godzin głodzenia
- •Przewidywana długość życia co najmniej 12 tygodni
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (73)
Keck School of Medicine of USC
Los Angeles, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, United States
Yale University
New Haven, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, United States
University of Emory - Winship Cancer Institute
Atlanta, United States
Dana-Farber Cancer Institute
Boston, United States
John Theurer Cancer Center / Hackensack University
Hackensack, United States
Roswell Park Comprehensive Cancer Center
Buffalo, United States
New York University Langone Hospital - Long Island
Mineola, United States
Perlmutter Cancer Center - 34th Street
New York, United States
Icahn School of Medicine at Mount Sinai
New York, United States
Weill Cornell Medical Center
New York, United States
Montefiore Medical Center
The Bronx, United States
Duke University
Durham, United States
Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
Columbus, United States
Oregon Health and Science University
Portland, United States
Oregon Oncology Specialists
Salem, United States
Hollings Cancer Center
Charleston, United States
Vanderbilt University Medical Center
Nashville, United States
Baylor Research Institute dba Baylor Scott & White Research Institute
Dallas, United States
University of Texas Southwestern Medical Center
Dallas, United States
MD Anderson Cancer Center
Houston, United States
Seattle Cancer Care Alliance
Seattle, United States
Froedtert & Medical College of Wisconsin
Milwaukee, United States
Eastern Health - Health Sciences Centre
St. John's, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Fakultni Nemocnice Ostrava
Ostrava, Czechia
Fakultní Nemocnice Královské Vinohrady
Prague, Czechia
Vseobecna Fakultni Nemocnice v Praze
Prague, Czechia
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
Toulouse, France
Hôpital l'Archet
Nice, France
Hôpital Saint-Louis
Paris, France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Städtisches Klinikum Braunschweig
Braunschweig, Germany
Universitätsklinikum Halle
Halle, Germany
Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati Klinika és Kardiológiai Központ
Szeged, Hungary
Petz Aladár Győr-Moson-Sopron Vármegyei Egyetemi Oktató Kórház
Győr, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hungary
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
Budapest, Hungary
Ospedale Santa Maria delle Croci di Ravenna
Ravenna, Italy
Azienda Ospedaliero - Universitaria Careggi
Florence, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy
Fondazione PTV - Policlinico Tor Vergata
Roma, Italy
Umberto I - Policlinico di Roma
Roma, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Italy
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Poland
Wojewódzkie Wielospecjalistyczne Centrum
Lodz, Poland
Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
Gdynia, Poland
Institut Català d'Oncologia Badalona
Badalona, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
L'Hospitalet de Llobregat, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital San Pedro de Alcantara
Cáceres, Spain
Institut Català d'Oncologia Girona (ICO Girona)
Girona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Clínica Universidad de Navarra - Madrid
Madrid, Spain
MD Anderson Cancer Center Madrid
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Quirónsalud Málaga
Málaga, Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
King's College Hospital NHS Foundation Trust
London, United Kingdom
Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital
Maidstone, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Trial contact
Taiho Oncology, Inc.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/7/2026.
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