Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

289

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Hematopoietic Neoplasm
Interventions
DRUG

SAR302503

"Pharmaceutical form:capsule~Route of administration: oral"

DRUG

Placebo

"Pharmaceutical form:capsule~Route of administration: oral"

Trial Locations (101)

112

Investigational Site Number 158001, Taipei

500

Investigational Site Number 158002, Changhua

833

Investigational Site Number 158003, Kaohsiung City

1090

Investigational Site Number 040001, Vienna

1097

Investigational Site Number 348002, Budapest

2013

Investigational Site Number 710003, Johannesburg

2031

Investigational Site Number 036003, Randwick

2060

Investigational Site Number 056003, Antwerp

2193

Investigational Site Number 710002, Parktown

2485

Investigational Site Number 036004, Tweed Heads

3000

Investigational Site Number 056001, Leuven

3128

Investigational Site Number 036001, Box Hill

3529

Investigational Site Number 348003, Miskolc

3690

Investigational Site Number 036002, Wodonga

4029

Investigational Site Number 036005, Herston

4032

Investigational Site Number 348001, Debrecen

6000

Investigational Site Number 348006, Kecskemét

9023

Investigational Site Number 348007, Győr

13273

Investigational Site Number 250006, Marseille

14186

Investigational Site Number 752001, Stockholm

21100

Investigational Site Number 380003, Varese

24127

Investigational Site Number 380002, Bergamo

27100

Investigational Site Number 380001, Pavia

Investigational Site Number 380006, Pavia

28046

Investigational Site Number 724002, Madrid

30029

Investigational Site Number 250004, Nîmes

31000

Investigational Site Number 250003, Toulouse

31048

Investigational Site Number 376003, Haifa

40138

Investigational Site Number 380007, Bologna

44093

Investigational Site Number 250005, Nantes

44718

Investigational Site Number 840002, Canton

50134

Investigational Site Number 380004, Florence

52074

Investigational Site Number 276006, Aachen

52621

Investigational Site Number 376002, Tel Litwinsky

53127

Investigational Site Number 276007, Bonn

55905

Investigational Site Number 840008, Rochester

68167

Investigational Site Number 276001, Mannheim

69495

Investigational Site Number 250002, Pierre-Bénite

70808

Investigational Site Number 840013, Baton Rouge

76000

Investigational Site Number 484001, Querétaro

77030

Investigational Site Number 840004, Houston

86000

Investigational Site Number 250007, Poitiers

90033

Investigational Site Number 840006, Los Angeles

92093

Investigational Site Number 840001, La Jolla

Investigational Site Number 840012, La Jolla

94805

Investigational Site Number 250001, Villejuif

119228

Investigational Site Number 702002, Singapore

125167

Investigational Site Number 643009, Moscow

125284

Investigational Site Number 643001, Moscow

169608

Investigational Site Number 702001, Singapore

185019

Investigational Site Number 643008, Petrozavodsk

191024

Investigational Site Number 643005, Saint Petersburg

197341

Investigational Site Number 643004, Saint Petersburg

400138

Investigational Site Number 643007, Volgograd

603126

Investigational Site Number 643010, Nizhny Novgorod

85259-5499

Investigational Site Number 840014, Scottsdale

07112

Investigational Site Number 840009, Newark

17210-120

Investigational Site Number 076002, Jaú

90110-270

Investigational Site Number 076004, Porto Alegre

20230-130

Investigational Site Number 076001, Rio de Janeiro

H1T 2M4

Investigational Site Number 124001, Montreal

H2W 1S6

Investigational Site Number 124003, Montreal

E2L 4L2

Investigational Site Number 124002, Saint John

01307

Investigational Site Number 276008, Dresden

DUBLIN 8

Investigational Site Number 372002, Dublin

Unknown

Investigational Site Number 372001, Galway

Investigational Site Number 642003, Brasov

Investigational Site Number 642006, Bucharest

Investigational Site Number 642001, Timișoara

Investigational Site Number 410007, Seoul

LT-50009

Investigational Site Number 440001, Kaunas

LT-92288

Investigational Site Number 440002, Klaipėda

36-200

Investigational Site Number 616005, Brzozów

80-952

Investigational Site Number 616002, Gdansk

93-510

Investigational Site Number 616006, Lodz

02-106

Investigational Site Number 616010, Warsaw

50-367

Investigational Site Number 616003, Wroclaw

3000-075

Investigational Site Number 620005, Coimbra

1169-050

Investigational Site Number 620004, Lisbon

1649-035

Investigational Site Number 620001, Lisbon

4200-072

Investigational Site Number 620003, Porto

022328

Investigational Site Number 642004, Bucharest

030171

Investigational Site Number 642002, Bucharest

463-707

Investigational Site Number 410002, Bundang-Gu

110-744

Investigational Site Number 410004, Seoul

120-752

Investigational Site Number 410003, Seoul

135-710

Investigational Site Number 410001, Seoul

137-701

Investigational Site Number 410005, Seoul

138-878

Investigational Site Number 410006, Seoul

08036

Investigational Site Number 724001, Barcelona

451 80

Investigational Site Number 752002, Uddevalla

BT9 7AB

Investigational Site Number 826006, Belfast

B9 5SS

Investigational Site Number 826003, Birmingham

G12 0YN

Investigational Site Number 826002, Glasgow

LS9 7TF

Investigational Site Number 826004, Leeds

SE1 9RT

Investigational Site Number 826001, London

W12 0HS

Investigational Site Number 826005, London

M20 4BX

Investigational Site Number 826007, Manchester

NE7 7DN

Investigational Site Number 826008, Newcastle upon Tyne

OX3 7LJ

Investigational Site Number 826009, Oxford

SO16 6YD

Investigational Site Number 826010, Southampton

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY