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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

236

Participants

Timeline

Start Date

May 21, 2020

Primary Completion Date

May 1, 2027

Study Completion Date

May 1, 2028

Conditions
Myelodysplastic SyndromesAcute Myeloid LeukemiaMyelodysplastic Syndrome/NeoplasmChronic Myelomonocytic Leukemia
Interventions
DRUG

Azacitidine

Tablets/Capsules for oral administration and powder for reconstitution to aqueous suspension for SC administration.

DRUG

ASTX030 (cedazuridine + azacitidine)

FDC Capsules for oral administration.

DRUG

Azacitidine

Powder for reconstitution to aqueous suspension for SC administration.

DRUG

ASTX030 (cedazuridine + azacitidine)

Tablets/Capsules for oral administration.

DRUG

Cedazuridine

Tablets for oral administration.

DRUG

Venetoclax

Oral tablets.

Trial Locations (72)

1088

NOT_YET_RECRUITING

Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika, Budapest

4032

NOT_YET_RECRUITING

Debreceni Egyetem Klinikai Központ, Debrecen

6725

NOT_YET_RECRUITING

Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati Klinika és Kardiológiai Központ, Szeged

9023

NOT_YET_RECRUITING

Petz Aladár Győr-Moson-Sopron Vármegyei Egyetemi Oktató Kórház, Győr

10003

RECRUITING

Hospital San Pedro de Alcantara, Cáceres

10016

RECRUITING

Perlmutter Cancer Center - 34th Street, New York

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

10065

WITHDRAWN

Weill Cornell Medical Center, New York

10126

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino, Torino

10128

NOT_YET_RECRUITING

Azienda Ospedaliera Ordine Mauriziano di Torino, Torino

11501

RECRUITING

New York University Langone Hospital - Long Island, Mineola

14263

RECRUITING

Roswell Park Comprehensive Cancer Center, Buffalo

14642

NOT_YET_RECRUITING

University of Rochester - Wilmot Cancer Center, Rochester

17007

NOT_YET_RECRUITING

Institut Català d'Oncologia Girona (ICO Girona), Girona

18014

NOT_YET_RECRUITING

Hospital Universitario Virgen de las Nieves, Granada

20122

NOT_YET_RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

27705

RECRUITING

Duke University, Durham

28007

NOT_YET_RECRUITING

Hospital General Universitario Gregorio Marañón, Madrid

28027

RECRUITING

Clínica Universidad de Navarra - Madrid, Madrid

28033

NOT_YET_RECRUITING

MD Anderson Cancer Center Madrid, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

28100

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Novara

29004

RECRUITING

Hospital Quirónsalud Málaga, Málaga

29425

RECRUITING

Hollings Cancer Center, Charleston

30322

NOT_YET_RECRUITING

University of Emory - Winship Cancer Institute, Atlanta

31008

RECRUITING

Clinica Universidad de Navarra - Pamplona, Pamplona

31059

RECRUITING

Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole, Toulouse

33011

NOT_YET_RECRUITING

Hospital Universitario Central de Asturias, Oviedo

33136

NOT_YET_RECRUITING

University of Miami - Sylvester Comprehensive Cancer Center, Miami

37007

RECRUITING

Complejo Asistencial Universitario de Salamanca - Hospital Clínico, Salamanca

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

38114

NOT_YET_RECRUITING

Städtisches Klinikum Braunschweig, Braunschweig

40138

RECRUITING

Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi, Bologna

43210

RECRUITING

Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute, Columbus

46026

RECRUITING

Hospital Universitari i Politècnic La Fe, Valencia

48121

NOT_YET_RECRUITING

Ospedale Santa Maria delle Croci di Ravenna, Ravenna

50134

RECRUITING

Azienda Ospedaliero - Universitaria Careggi, Florence

53226

NOT_YET_RECRUITING

Froedtert & Medical College of Wisconsin, Milwaukee

69120

NOT_YET_RECRUITING

Universitätsklinikum Heidelberg, Heidelberg

75010

RECRUITING

Hôpital Saint-Louis, Paris

75204

COMPLETED

Baylor Research Institute dba Baylor Scott & White Research Institute, Dallas

75390

RECRUITING

University of Texas Southwestern Medical Center, Dallas

77030

RECRUITING

MD Anderson Cancer Center, Houston

79106

NOT_YET_RECRUITING

Universitätsklinikum Freiburg, Freiburg im Breisgau

90089

RECRUITING

Keck School of Medicine of USC, Los Angeles

92868

NOT_YET_RECRUITING

UC Irvine Health - Chao Family Comprehensive Cancer Center, Orange

97239

RECRUITING

Oregon Health and Science University, Portland

97301

RECRUITING

Oregon Oncology Specialists, Salem

98109

RECRUITING

Seattle Cancer Care Alliance, Seattle

06510

RECRUITING

Yale University, New Haven

02114

RECRUITING

Dana-Farber Cancer Institute, Boston

07601

RECRUITING

John Theurer Cancer Center / Hackensack University, Hackensack

A1B 3V6

RECRUITING

Eastern Health - Health Sciences Centre, St. John's

M5G 2C1

RECRUITING

Princess Margaret Cancer Centre, Toronto

708 52

NOT_YET_RECRUITING

Fakultni Nemocnice Ostrava, Ostrava

100 34

RECRUITING

Fakultní Nemocnice Královské Vinohrady, Prague

128 08

NOT_YET_RECRUITING

Vseobecna Fakultni Nemocnice v Praze, Prague

625 00

WITHDRAWN

Fakultni Nemocnice Brno, Brno

06202

RECRUITING

Hôpital l'Archet, Nice

06120

NOT_YET_RECRUITING

Universitätsklinikum Halle, Halle

00133

NOT_YET_RECRUITING

Fondazione PTV - Policlinico Tor Vergata, Roma

00161

RECRUITING

Umberto I - Policlinico di Roma, Roma

20-081

NOT_YET_RECRUITING

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin

93-513

RECRUITING

Wojewódzkie Wielospecjalistyczne Centrum, Lodz

81-519

RECRUITING

Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością, Gdynia

08916

RECRUITING

Institut Català d'Oncologia Badalona, Badalona

08908

NOT_YET_RECRUITING

Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), L'Hospitalet de Llobregat

08035

NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebrón, Barcelona

08036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

SE5 9RS

NOT_YET_RECRUITING

King's College Hospital NHS Foundation Trust, London

M20 4GJ

NOT_YET_RECRUITING

The Christie NHS Foundation Trust, Manchester

SO16 6YD

NOT_YET_RECRUITING

University Hospital Southampton NHS Foundation Trust, Southampton

All Listed Sponsors
lead

Taiho Oncology, Inc.

INDUSTRY