An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia

PHASE3TerminatedINTERVENTIONAL
Enrollment

406

Participants

Timeline

Start Date

June 23, 2017

Primary Completion Date

August 20, 2020

Study Completion Date

August 20, 2020

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Pracinostat

60 mg capsule

DRUG

Placebos

capsule

DRUG

Azacitidine

SC or IV injection

Trial Locations (138)

100

Division of Hematology, National Taiwan University Hospital, Taipei

112

koo-Foundation Sun Yat-Sen Cancer Center, Taipei

500

Hematology and Oncology, Changhwa Christian Hospital, Changhua

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1130

General Hospital Hietzing, Vienna

2000

Sanatorio Britanico SA Paraguay 40, 3P, Rosario

2031

Prince of Wales Hospital, Randwick

2170

Liverpool Hospital, Liverpool

Liverpool hospital, Liverpool

3076

The Northern hospital Pharmacy Department, Ground Floor, Epping

3084

Austin Hospital, Clinical Trial Pharmacy, Heidelberg

3220

Barwon Health, University Hospital Geelong, Geelong

4020

Krankenhaus der Elisabethinen Linz GmbH, Linz

4575

Sunshine coast university hospital, Birtinya

5020

Müllner Hauptstrabe 48, Salzburg

6000

Royal Perth Hospital, Perth

7000

Royal Hobart Hospital, Hobart

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Dep. Of Haematology, Kaposvár

7624

university of Pécs, Pécs

10003

Hospital San Pedro de Alcantara, Cáceres

10034

Fakultni nemocnice Kralovske Vinohrady,, Prague

10117

Charité-Universitätsmedizin - 1. Campus Mitte, Berlin

10128

Azienda Ospedaliera Ordine Mauriziano, Torino

11794

Stony Brook University, Stony Brook

15006

Hosp.Universitario A Coruña-Hospital Teresa Herrera, A Coruña

16132

Ospedale Policlinico San Martino, Genova

20007

Georgetown University Medical Center, Washington D.C.

20132

Ospedale San Raffaele-U.O. Ematologia e TMO, Milan

20187

Rcca Md Llc, Bethesda

21565

Gachon University Gil medical center, div hematology, Incheon

22908

Emily Couric Clinical cancer center, Charlottesville

24116

Staedtisches krankenhaus kiel, Kiel

27100

Fondazione IRCCS policlinico San Matteo Pavia, Pavia

27710

Duke University Medical Center-2400 Pratt Street, Durham

28040

Hospital Clinico San Carlos, Madrid

28046

Hospital Universitario la Paz, Madrid

28050

Hospital Univers itario HM Sanchinarro, Madrid

29615

GHS Cancer Institute, Greenville

33604

Haut-Leveque-Service d'hématologie clinique et de thérapie cellular, Pessac

37007

Hospital Uni vcrsitario de Salamanca, Salamanca

37920

University of Tennessee Medical Center, Knoxville

40138

AOU Policlinico Sant'Orsola-Malpighi, Bologna

40207

Norton Cancer Institute, St. Matthews Campus, Louisville

40447

China Medical University Hospita, Taichung

44033

Ulsan University Hospital, Ulsan

44106

University Hospital Cleveland Medical Center, Cleveland

44277

L'Hopital privé du Confluent SAS, Nantes

44625

Marien Hospital Herne-Universitätsklinikum der Ruhr-Universität Bochum, Herne

46013

Hospital Universitario Virgen del Rocio, Seville

46026

Hospital Universitario y Politecnico de La Fe, Valencia

47392

Inje university Busan Paik Hospital, Busan

48336

Michigan Center of Medical Research, Farmington Hills

48910

Michigan State University, Lansing

50006

Changhua Christian Hospital, Changhua

50134

Azienda Ospedaliera-Università Careggi, Florence

55131

Universitaet Mainz, Mainz

55905

Mayo clinic, Rochester

58128

Chonnam National University Hwasun Hospital, Hwasun

60153

Loyola University Chicago, Maywood

64804

100 Mercy Way, Joplin

65804

Mercy Research, Springfield

66205

Universitz of Kansas Cancer Center, Westwood

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70124

AOU Policlinico Consorziale di Bari, Bari

70433

Pontchartrain Cancer Center (Research Location), Covington

73100

ospedale Vito Fazzi, Lecce

73120

Mercy Clinic Oncology & Hematology, Oklahoma City

74146

Oklahoma cancer specialist and research institute, Tulsa

75216

VA North texas Health Care sytem,Dallas VA Medical Center div. Hematology Oncology, Dallas

75475

Hospital saints Louis, Paris

76028

Centre Henri Becquerel, Rouen

77030

MD Anderson Cancer Center, Houston

77900

Fakultni nemocnice Olomuc, Olomouc

80131

Azienda Ospedaliere Antonio Cardarelli,, Naples

Azienda Ospedaliera Universitaria Federico II, Napoli

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

83706

Saint alphonsus Regional medical center-cancer care center, Boise

85054

Mayo clinic hospital, Phoenix

85284

Arizona Oncology Associates, East Valley Cancer Center, Tempe

85724

University of Arizona cancer center-north campus, Tucson

90146

Ospedale la Maddalena, UO Oncoematologia e TMO, Palermo

91054

Universitatsklinikum Erlangen, Erlangen

92037

10666 N.Torrey Pines-Scripps Cancer Center, La Jolla

92224

Klinikum St. Marien Amberg, Amberg

98104

Swedish Cancer Institute, Seattle

98108

Thomas Reeve Chauncey, Seattle

200143

Spitalul Clinic Filantropia, Craiova

400015

"Oncological Institute Ion Chiricuta", Cluj-Napoca

700483

institutu Regional de Oncologie Iasi, Iași

800054

CHU Amiens Picardie-Site Sud-Service d'Hematologie, Amiens

92093-0698

UC San Diego Moores Cancer Center, La Jolla

01655

UMass Memorial medical center-university campus, Worcester

C1181ACH

Hospital italiano de Buenos Aires, Ciudad Autonoma de Buenos Aire

C1426ANZ

Instituto Medico Especializado Alexander Fleming, Ciudad Autonoma de Buenos Aire

B1900AXI

hospital Italiano la Plata, La Plata

X5000JHQ

sanatorio Allende, Córdoba

X5016KEH

H ospi tal Privado de Cordoba, Córdoba

81520-060

Liga Paranaense de Com bate ao Cancer - Hospital Erasto Gaertner, Curitiba

17210-080

Ce ntro de Pesquisas Hospital Amara l Ca rvalh o, Jaú

0827-120

Centro de Pesquisa Clinica do Hospital Santa Marcelina, São Paulo

1478-400

Hospital de Cancer de Barretos, Barretos

30.150-221

Hospital Santa Casa de Belo Horizonte -Serviyo de Oncologia Clinica, Belo Horizonte

88034-000

Centro de Pesquisas Oncologicas - CEPON, Florianópolis

90035-903

Hospital de ClÃ-nicas de Porto Alegre, Porto Alegre

20231-050

Institute Nacional de Cancer Jose de Alencar Gomes da Silva-INCA, Rio de Janeiro

09060-870

Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André

15090-000

Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto

5oo 05

"Fakultni nemocnice Hradec Kralove,", Hradec Králové

100 34

"Fakultni nemocnice Kralovske Vinohrady,", Prague

I28 08

Vseobecna fakultni nemocnice, Prague

Unknown

CHU de Nice, Archet 1 Hospital-Hematology department, Nice

09116

Klinikum Chemnitz gGmbH, Chemnitz

07548

SRH Wald-Klinikum Gera GmbH, Gera

H-7624

Pecsi Egyetem I. Belgy6gyaszati Klinika, Pécs

H-1097

St. Istvan & St. Laszlo Hospital, Deapartment of Hematology and Stem Cell Transplantation, Budapest

H-4032

University of Debrecen Clinical Center, Debrecen

II-1065

"Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz †Josa Andras Oktatokorhaz, Hematologiai Osztaly", Nyíregyháza

00133

Fondazione PTV-Policlinico Tor Vergata, Roma

00168

Policlinico Universitario Gemelli, Roma

93-513

Wojewodzkie Wielospecjalistyczne Centrum onkologii I traumatologii, Lodz

60-192

Examen Sp. Z o.o.,, Poznan

58-309

Specjalistyc:my Szpi tal im. dra Alfreda Sokolowskiego, Wałbrzych

50-556

Uniwersytecki Szpital Kliniczny, Wroclaw

020125

Spitalul Clinic Colentina, Bucharest

030171

clinical hospital Coltea Bld, Bucharest

050098

Spitalul Universitar de Urgenta Bucuresti, Bucharest

0080

Seoul National University Hospital, Div.Hematology/Oncology, Seoul

06351

Sumsung medical center, Seoul

06591

Seoul St.Mary Hospital, div hemato-oncology, Seoul

08916

Institut Català D'Oncologia (ICO), Badalona

07120

Hospital Universitario Son Espases, Palma de Mallorca

08035

"Hospital Universitario Vall d'Hebron", Barcelona

08041

Hospital de La Santa Creu i Sant Pau, Barcelona

EX25DW

Royal Devon & Exeter Hospital (Wonford site), Exeter

FY3 8NR

Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool

BD9 6RJ

Bradford Teaching Hospitals NHS Foundation trust, Bradford

CV2 2DX

University Hospitals Coventry and Warwickshire NHS Trust, Coventry

L7 8XP

Royal Liverpool University Hospital, Liverpool

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Clinipace Worldwide

INDUSTRY

lead

Helsinn Healthcare SA

INDUSTRY