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

Primary Purpose

Hematopoietic Neoplasm

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SAR302503
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematopoietic Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Diagnosis of Primary Myelofibrosis (MF) or Post-Polycythemia Vera MF or Post-Essential Thrombocythemia MF, according to the 2008 World Health Organization and International Working Group of Myelofibrosis Research and Treatment (IWG-MRT) criteria.
  • MF classified as high-risk or intermediate-risk level 2, as defined by modified IWG-MRT criteria (IPSS) (according to Cervantes F. et. al.; at screening).
  • Enlarged spleen, palpable at least 5 cm below costal margin.
  • At least 18 years of age.
  • Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at study entry.
  • The following laboratory values within 14 days prior to the initiation of IMP or placebo:
  • Absolute Neutrophil Count (ANC) ≥1.0 x 10exp9/L
  • Platelet count ≥50 x 10exp9/L
  • Serum creatinine ≤1.5 x Upper Limit of Normal (ULN)
  • Serum amylase and lipase ≤1.5 x ULN

Exclusion criteria:

  • Splenectomy.
  • Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of IMP or placebo; darbepoetin use within 28 days prior to initiation of IMP or placebo. Patients who have had exposure to hydroxyurea (eg, hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to initiation of IMP or placebo.
  • Major surgery within 28 days or radiation within 6 months prior to initiation of IMP or placebo.
  • Prior treatment with a Janus Kinase 2 (JAK2) inhibitor.
  • Known active (acute or chronic) Hepatitis A, B, or C; and hepatitis B and C carriers
  • AST or ALT ≥2.5 x ULN
  • Total Bilirubin:
  • Exclude if ≥3.0 x ULN
  • Patients with total bilirubin between 1.5-3.0 x ULN must be excluded if the direct bilirubin fraction is ≥25% of the total
  • Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH])

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 840014
  • Investigational Site Number 840001
  • Investigational Site Number 840012
  • Investigational Site Number 840006
  • Investigational Site Number 840013
  • Investigational Site Number 840008
  • Investigational Site Number 840009
  • Investigational Site Number 840002
  • Investigational Site Number 840004
  • Investigational Site Number 036001
  • Investigational Site Number 036005
  • Investigational Site Number 036003
  • Investigational Site Number 036004
  • Investigational Site Number 036002
  • Investigational Site Number 040001
  • Investigational Site Number 056003
  • Investigational Site Number 056001
  • Investigational Site Number 076002
  • Investigational Site Number 076004
  • Investigational Site Number 076001
  • Investigational Site Number 124001
  • Investigational Site Number 124003
  • Investigational Site Number 124002
  • Investigational Site Number 250006
  • Investigational Site Number 250005
  • Investigational Site Number 250004
  • Investigational Site Number 250002
  • Investigational Site Number 250007
  • Investigational Site Number 250003
  • Investigational Site Number 250001
  • Investigational Site Number 276006
  • Investigational Site Number 276007
  • Investigational Site Number 276008
  • Investigational Site Number 276001
  • Investigational Site Number 348002
  • Investigational Site Number 348001
  • Investigational Site Number 348007
  • Investigational Site Number 348006
  • Investigational Site Number 348003
  • Investigational Site Number 372002
  • Investigational Site Number 372001
  • Investigational Site Number 376003
  • Investigational Site Number 376002
  • Investigational Site Number 380002
  • Investigational Site Number 380007
  • Investigational Site Number 380004
  • Investigational Site Number 380001
  • Investigational Site Number 380006
  • Investigational Site Number 380003
  • Investigational Site Number 410002
  • Investigational Site Number 410004
  • Investigational Site Number 410003
  • Investigational Site Number 410001
  • Investigational Site Number 410005
  • Investigational Site Number 410006
  • Investigational Site Number 410007
  • Investigational Site Number 440001
  • Investigational Site Number 440002
  • Investigational Site Number 484001
  • Investigational Site Number 616005
  • Investigational Site Number 616002
  • Investigational Site Number 616006
  • Investigational Site Number 616010
  • Investigational Site Number 616003
  • Investigational Site Number 620005
  • Investigational Site Number 620004
  • Investigational Site Number 620001
  • Investigational Site Number 620003
  • Investigational Site Number 642003
  • Investigational Site Number 642004
  • Investigational Site Number 642002
  • Investigational Site Number 642006
  • Investigational Site Number 642001
  • Investigational Site Number 643009
  • Investigational Site Number 643001
  • Investigational Site Number 643010
  • Investigational Site Number 643008
  • Investigational Site Number 643004
  • Investigational Site Number 643005
  • Investigational Site Number 643007
  • Investigational Site Number 702002
  • Investigational Site Number 702001
  • Investigational Site Number 710003
  • Investigational Site Number 710002
  • Investigational Site Number 724001
  • Investigational Site Number 724002
  • Investigational Site Number 752001
  • Investigational Site Number 752002
  • Investigational Site Number 158002
  • Investigational Site Number 158003
  • Investigational Site Number 158001
  • Investigational Site Number 826006
  • Investigational Site Number 826003
  • Investigational Site Number 826002
  • Investigational Site Number 826004
  • Investigational Site Number 826001
  • Investigational Site Number 826005
  • Investigational Site Number 826007
  • Investigational Site Number 826008
  • Investigational Site Number 826009
  • Investigational Site Number 826010

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo comparator

SAR302503 400 mg

SAR302503 500 mg

Arm Description

once daily X 28 days, orally, empty stomach, approximately same time each day

once daily X 28 days, orally, empty stomach, approximately same time each day

once daily X 28 days, orally, empty stomach, approximately same time each day

Outcomes

Primary Outcome Measures

Response Rate (RR), defined as the proportion of patients who have a ≥35% reduction in volume of spleen size at the end of Cycle 6, and confirmed 4 weeks thereafter

Secondary Outcome Measures

Symptom Response Rate (SRR): Proportion of patients with ≥50% reduction from baseline to the end of Cycle 6 in the total symptom score.
This assessment will be conducted through the modified MFSAF diary, which will be completed during the week prior to Day 1 of each treatment cycle up to Cycle 6, and during the week prior to the end of Cycle 6.
OS (overall survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.
PFS (progression free survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.
Proportion of patients who have ≥25% reduction in volume of spleen size at end of Cycle 6, and confirmed 4 weeks thereafter.
Duration of spleen response, measured by MRI (or CT scan in patients with contraindications for MRI.
Clinical and laboratory events graded by the NCI CTCAE v4.03.

Full Information

First Posted
September 16, 2011
Last Updated
December 8, 2015
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01437787
Brief Title
Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis
Acronym
JAKARTA
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients With Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
Primary Objective: To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI). Secondary Objectives: To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary. To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. To evaluate the durability of splenic response. To evaluate the safety of IMP.
Detailed Description
The expected duration of a patient's treatment in this study is approximately 8 months, based on a maximum 28-day screening period, followed by a ≥6-month (6-cycle) treatment period, and an End Of Treatment (EOT) visit, which should be performed at least 30 days following the last administration of IMP or placebo. Patients who continue to benefit clinically will be allowed to remain on IMP or placebo beyond the 6-month treatment period until the occurrence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
289 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm Description
once daily X 28 days, orally, empty stomach, approximately same time each day
Arm Title
SAR302503 400 mg
Arm Type
Experimental
Arm Description
once daily X 28 days, orally, empty stomach, approximately same time each day
Arm Title
SAR302503 500 mg
Arm Type
Experimental
Arm Description
once daily X 28 days, orally, empty stomach, approximately same time each day
Intervention Type
Drug
Intervention Name(s)
SAR302503
Intervention Description
Pharmaceutical form:capsule Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form:capsule Route of administration: oral
Primary Outcome Measure Information:
Title
Response Rate (RR), defined as the proportion of patients who have a ≥35% reduction in volume of spleen size at the end of Cycle 6, and confirmed 4 weeks thereafter
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Symptom Response Rate (SRR): Proportion of patients with ≥50% reduction from baseline to the end of Cycle 6 in the total symptom score.
Description
This assessment will be conducted through the modified MFSAF diary, which will be completed during the week prior to Day 1 of each treatment cycle up to Cycle 6, and during the week prior to the end of Cycle 6.
Time Frame
6 months
Title
OS (overall survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.
Time Frame
approximately 5 years
Title
PFS (progression free survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.
Time Frame
approximately 5 years
Title
Proportion of patients who have ≥25% reduction in volume of spleen size at end of Cycle 6, and confirmed 4 weeks thereafter.
Time Frame
6 months
Title
Duration of spleen response, measured by MRI (or CT scan in patients with contraindications for MRI.
Time Frame
2 years
Title
Clinical and laboratory events graded by the NCI CTCAE v4.03.
Time Frame
approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of Primary Myelofibrosis (MF) or Post-Polycythemia Vera MF or Post-Essential Thrombocythemia MF, according to the 2008 World Health Organization and International Working Group of Myelofibrosis Research and Treatment (IWG-MRT) criteria. MF classified as high-risk or intermediate-risk level 2, as defined by modified IWG-MRT criteria (IPSS) (according to Cervantes F. et. al.; at screening). Enlarged spleen, palpable at least 5 cm below costal margin. At least 18 years of age. Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at study entry. The following laboratory values within 14 days prior to the initiation of IMP or placebo: Absolute Neutrophil Count (ANC) ≥1.0 x 10exp9/L Platelet count ≥50 x 10exp9/L Serum creatinine ≤1.5 x Upper Limit of Normal (ULN) Serum amylase and lipase ≤1.5 x ULN Exclusion criteria: Splenectomy. Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of IMP or placebo; darbepoetin use within 28 days prior to initiation of IMP or placebo. Patients who have had exposure to hydroxyurea (eg, hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to initiation of IMP or placebo. Major surgery within 28 days or radiation within 6 months prior to initiation of IMP or placebo. Prior treatment with a Janus Kinase 2 (JAK2) inhibitor. Known active (acute or chronic) Hepatitis A, B, or C; and hepatitis B and C carriers AST or ALT ≥2.5 x ULN Total Bilirubin: Exclude if ≥3.0 x ULN Patients with total bilirubin between 1.5-3.0 x ULN must be excluded if the direct bilirubin fraction is ≥25% of the total Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH]) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840014
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Investigational Site Number 840001
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Investigational Site Number 840012
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Investigational Site Number 840006
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Investigational Site Number 840013
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Investigational Site Number 840008
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Investigational Site Number 840009
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Investigational Site Number 840002
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Investigational Site Number 840004
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number 036001
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Investigational Site Number 036005
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
Investigational Site Number 036003
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Investigational Site Number 036004
City
Tweed Heads
ZIP/Postal Code
2485
Country
Australia
Facility Name
Investigational Site Number 036002
City
Wodonga
ZIP/Postal Code
3690
Country
Australia
Facility Name
Investigational Site Number 040001
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Investigational Site Number 056003
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Investigational Site Number 056001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigational Site Number 076002
City
Jau
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Investigational Site Number 076004
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Investigational Site Number 076001
City
Rio De Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Investigational Site Number 124001
City
Montreal
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Investigational Site Number 124003
City
Montreal
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Investigational Site Number 124002
City
Saint John
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Investigational Site Number 250006
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Investigational Site Number 250005
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number 250004
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Investigational Site Number 250002
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Investigational Site Number 250007
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Investigational Site Number 250003
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Investigational Site Number 250001
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Investigational Site Number 276006
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Investigational Site Number 276007
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Investigational Site Number 276008
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigational Site Number 276001
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Investigational Site Number 348002
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Investigational Site Number 348001
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Investigational Site Number 348007
City
Györ
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Investigational Site Number 348006
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Investigational Site Number 348003
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Investigational Site Number 372002
City
Dublin
ZIP/Postal Code
DUBLIN 8
Country
Ireland
Facility Name
Investigational Site Number 372001
City
Galway
Country
Ireland
Facility Name
Investigational Site Number 376003
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Investigational Site Number 376002
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Investigational Site Number 380002
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Investigational Site Number 380007
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Investigational Site Number 380004
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Investigational Site Number 380001
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Investigational Site Number 380006
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Investigational Site Number 380003
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Investigational Site Number 410002
City
Bundang-Gu
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Investigational Site Number 410004
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Investigational Site Number 410003
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Investigational Site Number 410001
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Investigational Site Number 410005
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Investigational Site Number 410006
City
Seoul
ZIP/Postal Code
138-878
Country
Korea, Republic of
Facility Name
Investigational Site Number 410007
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site Number 440001
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Investigational Site Number 440002
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Investigational Site Number 484001
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Investigational Site Number 616005
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Investigational Site Number 616002
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Investigational Site Number 616006
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Investigational Site Number 616010
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Investigational Site Number 616003
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Investigational Site Number 620005
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Investigational Site Number 620004
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Investigational Site Number 620001
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Investigational Site Number 620003
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Investigational Site Number 642003
City
Brasov
Country
Romania
Facility Name
Investigational Site Number 642004
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Investigational Site Number 642002
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Investigational Site Number 642006
City
Bucuresti
Country
Romania
Facility Name
Investigational Site Number 642001
City
Timisoara
Country
Romania
Facility Name
Investigational Site Number 643009
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Investigational Site Number 643010
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Investigational Site Number 643008
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Investigational Site Number 643004
City
St-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Investigational Site Number 643005
City
St.-Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Investigational Site Number 643007
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Investigational Site Number 702002
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Investigational Site Number 702001
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Investigational Site Number 710003
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Investigational Site Number 710002
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Investigational Site Number 724001
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number 724002
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Investigational Site Number 752001
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Investigational Site Number 752002
City
Uddevalla
ZIP/Postal Code
451 80
Country
Sweden
Facility Name
Investigational Site Number 158002
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Investigational Site Number 158003
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Investigational Site Number 158001
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Investigational Site Number 826006
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Investigational Site Number 826003
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Investigational Site Number 826002
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Investigational Site Number 826004
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Investigational Site Number 826001
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Investigational Site Number 826005
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Investigational Site Number 826007
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Investigational Site Number 826008
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Investigational Site Number 826009
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Investigational Site Number 826010
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26181658
Citation
Pardanani A, Harrison C, Cortes JE, Cervantes F, Mesa RA, Milligan D, Masszi T, Mishchenko E, Jourdan E, Vannucchi AM, Drummond MW, Jurgutis M, Kuliczkowski K, Gheorghita E, Passamonti F, Neumann F, Patki A, Gao G, Tefferi A. Safety and Efficacy of Fedratinib in Patients With Primary or Secondary Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2015 Aug;1(5):643-51. doi: 10.1001/jamaoncol.2015.1590.
Results Reference
derived

Learn more about this trial

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

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