An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

PHASE3CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

September 9, 2019

Primary Completion Date

December 15, 2022

Study Completion Date

July 28, 2025

Conditions
Primary MyelofibrosisPost-Polycythemia VeraMyelofibrosis
Interventions
DRUG

FEDRATINIB

A potent and selective inhibitor of JAK2 kinase activity

DRUG

Best Available Therapy (BAT)

Best available therapy (BAT)

Trial Locations (107)

0

Local Institution - 557, Zhengzhou

1088

Local Institution - 600, Budapest

1090

Local Institution - 150, Vienna

1140

Local Institution - 152, Vienna

1200

Local Institution - 202, Brussels

2010

Local Institution - 103, Darlinghurst

3000

Local Institution - 201, Leuven

3004

Local Institution - 100, Melbourne

3080

Local Institution - 904, Seoul

3128

Local Institution - 105, Box Hill

3910

Local Institution - 102, Langwarrin

4000

Local Institution - 204, Liège

4020

Local Institution - 155, Linz

4400

Local Institution - 604, Nyíregyháza

4600

Local Institution - 153, Wels

5000

Local Institution - 101, Adelaide

5020

Local Institution - 151, Salzburg

5505

Local Institution - 902, Seoul

5530

Local Institution - 203, Yvoir

6020

Local Institution - 154, Innsbruck

6720

Local Institution - 603, Szeged

7100

Local Institution - 205, La Louvière-(Haine St-Paul)

7400

Local Institution - 602, Kaposvár

8000

Local Institution - 200, Bruges

8916

Local Institution - 452, Badalona (Barcelona)

9024

Local Institution - 601, Győr

10126

Local Institution - 355, Torino

13620

Local Institution - 900, Seongnam-si

15706

Local Institution - 460, Santiago de Compostela

17007

Local Institution - 462, Girona

20122

Local Institution - 358, Milan

21100

Local Institution - 352, Varese

25123

Local Institution - 363, Brescia

27100

Local Institution - 357, Pavia

28034

Local Institution - 453, Madrid

28041

Local Institution - 459, Madrid

29010

Local Institution - 457, Málaga

29200

Local Institution - 256, Brest

30008

Local Institution - 454, Murcia

30029

Local Institution - 250, Nîmes

31059

Local Institution - 253, Toulouse

32429

Local Institution - 304, Minden

33100

Local Institution - 360, Udine

33604

Local Institution - 258, Pessac

35012

Local Institution - 461, Las Palmas de Gran Canaria

37007

Local Institution - 455, Salamanca

37134

Local Institution - 364, Verona

38320

Local Institution - 463, Santa Cruz de Tenerife

39120

Local Institution - 307, Magdeburg

40138

Local Institution - 353, Bologna

46010

Local Institution - 456, Valencia

48903

Local Institution - 458, Barakaldo

49033

Local Institution - 255, Angers

50134

Local Institution - 350, Florence

52074

Local Institution - 302, Aachen

59037

Local Institution - 259, Lille

60590

Local Institution - 308, Frankfurt am Main

62307

Local Institution - 254, Lens

67091

Local Institution - 251, Strasbourg

68167

Local Institution - 301, Mannheim

69495

Local Institution - 257, Pierre-Bénite

73013

Local Institution - 156, Graz

75010

Local Institution - 252, Paris

80131

Local Institution - 362, Naples

86021

Local Institution - 261, Poitiers

89081

Local Institution - 305, Ulm

95123

Local Institution - 354, Catania

100044

Local Institution - 555, Beijing

125167

Local Institution - 855, Moscow

125284

Local Institution - 851, Moscow

129301

Local Institution - 853, Moscow

191024

Local Institution - 852, Saint Petersburg

197022

Local Institution - 854, Saint Petersburg

197341

Local Institution - 850, Saint Petersburg

300041

Local Institution - 553, Tianjin

362002

Local Institution - 859, Vladikavkaz

510080

Local Institution - 550, Guangzhou, Guangdong

630066

Local Institution - 857, Novosibirsk

625 00

Local Institution - 700, Brno

708 52

Local Institution - 702, Ostrava-Poruba

128 08

Local Institution - 701, Prague

06200

Local Institution - 260, Nice

06120

Local Institution - 306, Halle

07747

Local Institution - 303, Jena

T12 DFK4

Local Institution - 751, Cork

Dublin 7

Local Institution - 752, Dublin

Dublin 8

Local Institution - 750, Dublin

00168

Local Institution - 356, Roma

Local Institution - 361, Roma

00189

Local Institution - 359, Roma

6229 HX

Local Institution - 402, Maastricht

6525 GA

Local Institution - 400, Nijmegen

61-848

Local Institution - 803, Poznan

02-776

Local Institution - 801, Warsaw

50-556

Local Institution - 802, Wroclaw

06351

Local Institution - 905, Seoul

06591

Local Institution - 901, Seoul

140-887

Local Institution - 903, Seoul

03010

Local Institution - 451, Alicante

08036

Local Institution - 450, Barcelona

M20 4BX

Local Institution - 504, Manchester

NG5 1PB

Local Institution - 506, Nottingham

B15 2TH

Local Institution - 502, Birmingham

PE21 9QS

Local Institution - 503, Boston

SE1 9RT

Local Institution - 501, London

W12 0HS

Local Institution - 505, London

0X3 7LE

Local Institution - 500, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

collaborator

Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation

INDUSTRY

NCT03952039 - An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib | Biotech Hunter | Biotech Hunter