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Hematopoietic NeoplasmPhase 3JAKARTANCT01437787

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

A Phase 3 study testing SAR302503 in people with Hematopoietic Neoplasm, run by Bristol-Myers Squibb at 101 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematopoietic Neoplasm
What is being tested?
SAR302503
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
289 participants
Where
101 sitesin 25 countries
Study dates
31 Dec 2011to 30 Jun 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

101 sites in 25 countries.

101 sites in 25 countries

United Kingdom10 sites

  • Investigational Site Number 826006

    Belfast, BT9 7AB

  • Investigational Site Number 826003

    Birmingham, B9 5SS

  • Investigational Site Number 826002

    Glasgow, G12 0YN

  • Investigational Site Number 826004

    Leeds, LS9 7TF

  • Investigational Site Number 826001

    London, SE1 9RT

  • Investigational Site Number 826005

    London, W12 0HS

  • Investigational Site Number 826007

    Manchester, M20 4BX

  • Investigational Site Number 826008

    Newcastle upon Tyne, NE7 7DN

  • Investigational Site Number 826009

    Oxford, OX3 7LJ

  • Investigational Site Number 826010

    Southampton, SO16 6YD

Other trials in United Kingdom

United States9 sites

  • Investigational Site Number 840013

    Baton Rouge, Louisiana, 70808

  • Investigational Site Number 840002

    Canton, Ohio, 44718

  • Investigational Site Number 840004

    Houston, Texas, 77030

  • Investigational Site Number 840001

    La Jolla, California, 92093

  • Investigational Site Number 840012

    La Jolla, California, 92093

  • Investigational Site Number 840006

    Los Angeles, California, 90033

  • Investigational Site Number 840009

    Newark, New Jersey, 07112

  • Investigational Site Number 840008

    Rochester, Minnesota, 55905

  • Investigational Site Number 840014

    Scottsdale, Arizona, 85259-5499

Other trials in United States

France7 sites

  • Investigational Site Number 250006

    Marseille, 13273

  • Investigational Site Number 250005

    Nantes, 44093

  • Investigational Site Number 250004

    Nîmes, 30029

  • Investigational Site Number 250002

    Pierre-Bénite, 69495

  • Investigational Site Number 250007

    Poitiers, 86000

  • Investigational Site Number 250003

    Toulouse, 31000

  • Investigational Site Number 250001

    Villejuif, 94805

Other trials in France

Russia7 sites

  • Investigational Site Number 643009

    Moscow, 125167

  • Investigational Site Number 643001

    Moscow, 125284

  • Investigational Site Number 643010

    Nizhny Novgorod, 603126

  • Investigational Site Number 643008

    Petrozavodsk, 185019

  • Investigational Site Number 643005

    Saint Petersburg, 191024

  • Investigational Site Number 643004

    Saint Petersburg, 197341

  • Investigational Site Number 643007

    Volgograd, 400138

Other trials in Russia

South Korea7 sites

  • Investigational Site Number 410002

    Bundang-Gu, 463-707

  • Investigational Site Number 410004

    Seoul, 110-744

  • Investigational Site Number 410003

    Seoul, 120-752

  • Investigational Site Number 410001

    Seoul, 135-710

  • Investigational Site Number 410005

    Seoul, 137-701

  • Investigational Site Number 410006

    Seoul, 138-878

  • Investigational Site Number 410007

    Seoul

Other trials in South Korea

Italy6 sites

  • Investigational Site Number 380002

    Bergamo, 24127

  • Investigational Site Number 380007

    Bologna, 40138

  • Investigational Site Number 380004

    Florence, 50134

  • Investigational Site Number 380001

    Pavia, 27100

  • Investigational Site Number 380006

    Pavia, 27100

  • Investigational Site Number 380003

    Varese, 21100

Other trials in Italy

Australia5 sites

  • Investigational Site Number 036001

    Box Hill, 3128

  • Investigational Site Number 036005

    Herston, 4029

  • Investigational Site Number 036003

    Randwick, 2031

  • Investigational Site Number 036004

    Tweed Heads, 2485

  • Investigational Site Number 036002

    Wodonga, 3690

Other trials in Australia

Hungary5 sites

  • Investigational Site Number 348002

    Budapest, 1097

  • Investigational Site Number 348001

    Debrecen, 4032

  • Investigational Site Number 348007

    Győr, 9023

  • Investigational Site Number 348006

    Kecskemét, 6000

  • Investigational Site Number 348003

    Miskolc, 3529

Other trials in Hungary

Poland5 sites

  • Investigational Site Number 616005

    Brzozów, 36-200

  • Investigational Site Number 616002

    Gdansk, 80-952

  • Investigational Site Number 616006

    Lodz, 93-510

  • Investigational Site Number 616010

    Warsaw, 02-106

  • Investigational Site Number 616003

    Wroclaw, 50-367

Other trials in Poland

Romania5 sites

  • Investigational Site Number 642003

    Brasov

  • Investigational Site Number 642004

    Bucharest, 022328

  • Investigational Site Number 642002

    Bucharest, 030171

  • Investigational Site Number 642006

    Bucharest

  • Investigational Site Number 642001

    Timișoara

Other trials in Romania

Germany4 sites

  • Investigational Site Number 276006

    Aachen, 52074

  • Investigational Site Number 276007

    Bonn, 53127

  • Investigational Site Number 276008

    Dresden, 01307

  • Investigational Site Number 276001

    Mannheim, 68167

Other trials in Germany

Portugal4 sites

  • Investigational Site Number 620005

    Coimbra, 3000-075

  • Investigational Site Number 620004

    Lisbon, 1169-050

  • Investigational Site Number 620001

    Lisbon, 1649-035

  • Investigational Site Number 620003

    Porto, 4200-072

Other trials in Portugal

Brazil3 sites

  • Investigational Site Number 076002

    Jaú, 17210-120

  • Investigational Site Number 076004

    Porto Alegre, 90110-270

  • Investigational Site Number 076001

    Rio de Janeiro, 20230-130

Other trials in Brazil

Canada3 sites

  • Investigational Site Number 124001

    Montreal, H1T 2M4

  • Investigational Site Number 124003

    Montreal, H2W 1S6

  • Investigational Site Number 124002

    Saint John, E2L 4L2

Other trials in Canada

Taiwan3 sites

  • Investigational Site Number 158002

    Changhua, 500

  • Investigational Site Number 158003

    Kaohsiung City, 833

  • Investigational Site Number 158001

    Taipei, 112

Other trials in Taiwan

Belgium2 sites

  • Investigational Site Number 056003

    Antwerp, 2060

  • Investigational Site Number 056001

    Leuven, 3000

Other trials in Belgium

Ireland2 sites

  • Investigational Site Number 372002

    Dublin, DUBLIN 8

  • Investigational Site Number 372001

    Galway

Other trials in Ireland

Israel2 sites

  • Investigational Site Number 376003

    Haifa, 31048

  • Investigational Site Number 376002

    Tel Litwinsky, 52621

Other trials in Israel

Lithuania2 sites

  • Investigational Site Number 440001

    Kaunas, LT-50009

  • Investigational Site Number 440002

    Klaipėda, LT-92288

Other trials in Lithuania

Singapore2 sites

  • Investigational Site Number 702002

    Singapore, 119228

  • Investigational Site Number 702001

    Singapore, 169608

Other trials in Singapore

South Africa2 sites

  • Investigational Site Number 710003

    Johannesburg, 2013

  • Investigational Site Number 710002

    Parktown, 2193

Other trials in South Africa

Spain2 sites

  • Investigational Site Number 724001

    Barcelona, 08036

  • Investigational Site Number 724002

    Madrid, 28046

Other trials in Spain

Sweden2 sites

  • Investigational Site Number 752001

    Stockholm, 14186

  • Investigational Site Number 752002

    Uddevalla, 451 80

Other trials in Sweden

Austria1 site

  • Investigational Site Number 040001

    Vienna, 1090

Other trials in Austria

Mexico1 site

  • Investigational Site Number 484001

    Querétaro, 76000

Other trials in Mexico

About this study

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

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).
Read more

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.
Read the 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.

Being tested
SAR302503, Placebo
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR302503Drug

    Pharmaceutical form:capsule

    Route of administration: oral

  • PlaceboDrug

    Pharmaceutical form:capsule

    Route of administration: oral

Study groups in NCT01437787
Study groupRoleWhat they receive
Placebo comparatorPlacebo comparatoronce daily X 28 days, orally, empty stomach, approximately same time each day
Receives: Drug: Placebo
SAR302503 400 mgExperimentalonce daily X 28 days, orally, empty stomach, approximately same time each day
Receives: Drug: SAR302503
SAR302503 500 mgExperimentalonce daily X 28 days, orally, empty stomach, approximately same time each day
Receives: Drug: SAR302503

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate (RR): Percentage of Participants Who Had a >=35% Reduction From Baseline in Volume of Spleen Size at The End Cycle 6

    Spleen volume was determined by magnetic resonance imaging (MRI) (or computed tomography scan in participants with contraindications for MRI) at baseline and at the end of cycle 6 with a confirmatory scan approximately 4 weeks after the end of Cycle 6. The MRI or CT imaging results reviewed in a blinded manner by an Independent Review Committee (IRC). Analysis was performed on intent-to-treat (ITT) population defined as all randomized participants who signed informed consent form (ICF).

    Measured: Baseline, Week 24

Secondary outcomes (2)

  1. Symptom Response Rate (SRR): Percentage of Participants With >=50% Reduction From Baseline in the Total Symptom Score at End of Cycle 6

    Total symptom score is the averaged value of the daily scores for each of 6 key Myelofibrosis (MF) associated Symptom items (night sweats, pruritus, abdominal discomfort, early satiety [filling up quickly when you eat], pain under ribs on left side, and bone or muscle pain), each item measured on a scale from 0 (absent) to 10 (worst imaginable). A higher score indicates worse symptoms. Analysis was performed on ITT population. Number of participants analysed= participants with available data at end of cycle 6.

    Measured: Baseline, Week 24

  2. Percentage of Participants Who Had >=25% Reduction From Baseline in Volume of Spleen Size at End of Cycle 6

    Spleen volume was determined by magnetic resonance imaging (MRI) (or computed tomography scan in subjects with contraindications for MRI) at baseline and at the end of cycle 6 with a confirmatory scan approximately 4 weeks after the end of Cycle 6. Analysis was performed on ITT population.

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2011 (estimated)
  2. Study start31 Dec 2011
  3. Primary completion30 Jun 2014
  4. Study completion30 Jun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01437787
Sponsor's protocol ID
EFC12153
Other IDs
2011-001897-25, U1111-1121-7170
Acronym
JAKARTA
Status last verified
Jul 2026
First submitted
16 Sep 2011
Last updated
11 Aug 2026

Publications

  • 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.

    PubMed 26181658

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SAR302503 in people with Hematopoietic Neoplasm, run by Bristol-Myers Squibb at 101 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United Kingdom, United States, France, Russia, South Korea and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (RR): Percentage of Participants Who Had a >=35% Reduction From Baseline in Volume of Spleen Size at The End Cycle 6 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01437787, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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