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Can a daily pill shrink the spleen in myelofibrosis?

NCT ID NCT01437787

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This phase 3 trial is testing an experimental oral drug, SAR302503, in people with a rare bone marrow disorder called myelofibrosis who have an enlarged spleen. Participants are randomly assigned to receive one of two doses of the drug or a placebo. The main goal is to see if the drug can reduce spleen size by at least 35% after six months of treatment, which could help ease related symptoms like pain and discomfort.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR302503, an experimental oral drug taken daily as a capsule
What this could lead to
If it works, this could offer a new treatment option to shrink the enlarged spleen and ease symptoms in people with myelofibrosis, potentially improving quality of life.
What could go wrong
This is an early-stage test in a specific group of patients, and the drug may not prove more effective than placebo. Side effects are possible, and results may not apply to all patients with myelofibrosis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

289 people

The number who actually took part.

Started

Dec 2011

Finished

Jun 2014

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm primary myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematopoietic neoplasm

Contacts and locations

Locations

  • Investigational Site Number 036001

    Box Hill, 3128, Australia

  • Investigational Site Number 036002

    Wodonga, 3690, Australia

  • Investigational Site Number 036003

    Randwick, 2031, Australia

  • Investigational Site Number 036004

    Tweed Heads, 2485, Australia

  • Investigational Site Number 036005

    Herston, 4029, Australia

  • Investigational Site Number 040001

    Vienna, 1090, Austria

  • Investigational Site Number 056001

    Leuven, 3000, Belgium

  • Investigational Site Number 056003

    Antwerp, 2060, Belgium

  • Investigational Site Number 076001

    Rio de Janeiro, 20230-130, Brazil

  • Investigational Site Number 076002

    Jaú, 17210-120, Brazil

  • Investigational Site Number 076004

    Porto Alegre, 90110-270, Brazil

  • Investigational Site Number 124001

    Montreal, H1T 2M4, Canada

  • Investigational Site Number 124002

    Saint John, E2L 4L2, Canada

  • Investigational Site Number 124003

    Montreal, H2W 1S6, Canada

  • Investigational Site Number 158001

    Taipei, 112, Taiwan

  • Investigational Site Number 158002

    Changhua, 500, Taiwan

  • Investigational Site Number 158003

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number 250001

    Villejuif, 94805, France

  • Investigational Site Number 250002

    Pierre-Bénite, 69495, France

  • Investigational Site Number 250003

    Toulouse, 31000, France

  • Investigational Site Number 250004

    Nîmes, 30029, France

  • Investigational Site Number 250005

    Nantes, 44093, France

  • Investigational Site Number 250006

    Marseille, 13273, France

  • Investigational Site Number 250007

    Poitiers, 86000, France

  • Investigational Site Number 276001

    Mannheim, 68167, Germany

  • Investigational Site Number 276006

    Aachen, 52074, Germany

  • Investigational Site Number 276007

    Bonn, 53127, Germany

  • Investigational Site Number 276008

    Dresden, 01307, Germany

  • Investigational Site Number 348001

    Debrecen, 4032, Hungary

  • Investigational Site Number 348002

    Budapest, 1097, Hungary

  • Investigational Site Number 348003

    Miskolc, 3529, Hungary

  • Investigational Site Number 348006

    Kecskemét, 6000, Hungary

  • Investigational Site Number 348007

    Győr, 9023, Hungary

  • Investigational Site Number 372001

    Galway, Ireland

  • Investigational Site Number 372002

    Dublin, DUBLIN 8, Ireland

  • Investigational Site Number 376002

    Tel Litwinsky, 52621, Israel

  • Investigational Site Number 376003

    Haifa, 31048, Israel

  • Investigational Site Number 380001

    Pavia, 27100, Italy

  • Investigational Site Number 380002

    Bergamo, 24127, Italy

  • Investigational Site Number 380003

    Varese, 21100, Italy

  • Investigational Site Number 380004

    Florence, 50134, Italy

  • Investigational Site Number 380006

    Pavia, 27100, Italy

  • Investigational Site Number 380007

    Bologna, 40138, Italy

  • Investigational Site Number 410001

    Seoul, 135-710, South Korea

  • Investigational Site Number 410002

    Bundang-Gu, 463-707, South Korea

  • Investigational Site Number 410003

    Seoul, 120-752, South Korea

  • Investigational Site Number 410004

    Seoul, 110-744, South Korea

  • Investigational Site Number 410005

    Seoul, 137-701, South Korea

  • Investigational Site Number 410006

    Seoul, 138-878, South Korea

  • Investigational Site Number 410007

    Seoul, South Korea

  • Investigational Site Number 440001

    Kaunas, LT-50009, Lithuania

  • Investigational Site Number 440002

    Klaipėda, LT-92288, Lithuania

  • Investigational Site Number 484001

    Querétaro, 76000, Mexico

  • Investigational Site Number 616002

    Gdansk, 80-952, Poland

  • Investigational Site Number 616003

    Wroclaw, 50-367, Poland

  • Investigational Site Number 616005

    Brzozów, 36-200, Poland

  • Investigational Site Number 616006

    Lodz, 93-510, Poland

  • Investigational Site Number 616010

    Warsaw, 02-106, Poland

  • Investigational Site Number 620001

    Lisbon, 1649-035, Portugal

  • Investigational Site Number 620003

    Porto, 4200-072, Portugal

  • Investigational Site Number 620004

    Lisbon, 1169-050, Portugal

  • Investigational Site Number 620005

    Coimbra, 3000-075, Portugal

  • Investigational Site Number 642001

    Timișoara, Romania

  • Investigational Site Number 642002

    Bucharest, 030171, Romania

  • Investigational Site Number 642003

    Brasov, Romania

  • Investigational Site Number 642004

    Bucharest, 022328, Romania

  • Investigational Site Number 642006

    Bucharest, Romania

  • Investigational Site Number 643001

    Moscow, 125284, Russia

  • Investigational Site Number 643004

    Saint Petersburg, 197341, Russia

  • Investigational Site Number 643005

    Saint Petersburg, 191024, Russia

  • Investigational Site Number 643007

    Volgograd, 400138, Russia

  • Investigational Site Number 643008

    Petrozavodsk, 185019, Russia

  • Investigational Site Number 643009

    Moscow, 125167, Russia

  • Investigational Site Number 643010

    Nizhny Novgorod, 603126, Russia

  • Investigational Site Number 702001

    Singapore, 169608, Singapore

  • Investigational Site Number 702002

    Singapore, 119228, Singapore

  • Investigational Site Number 710002

    Parktown, 2193, South Africa

  • Investigational Site Number 710003

    Johannesburg, 2013, South Africa

  • Investigational Site Number 724001

    Barcelona, 08036, Spain

  • Investigational Site Number 724002

    Madrid, 28046, Spain

  • Investigational Site Number 752001

    Stockholm, 14186, Sweden

  • Investigational Site Number 752002

    Uddevalla, 451 80, Sweden

  • Investigational Site Number 826001

    London, SE1 9RT, United Kingdom

  • Investigational Site Number 826002

    Glasgow, G12 0YN, United Kingdom

  • Investigational Site Number 826003

    Birmingham, B9 5SS, United Kingdom

  • Investigational Site Number 826004

    Leeds, LS9 7TF, United Kingdom

  • Investigational Site Number 826005

    London, W12 0HS, United Kingdom

  • Investigational Site Number 826006

    Belfast, BT9 7AB, United Kingdom

  • Investigational Site Number 826007

    Manchester, M20 4BX, United Kingdom

  • Investigational Site Number 826008

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Investigational Site Number 826009

    Oxford, OX3 7LJ, United Kingdom

  • Investigational Site Number 826010

    Southampton, SO16 6YD, United Kingdom

  • Investigational Site Number 840001

    La Jolla, California, 92093, United States

  • Investigational Site Number 840002

    Canton, Ohio, 44718, United States

  • Investigational Site Number 840004

    Houston, Texas, 77030, United States

  • Investigational Site Number 840006

    Los Angeles, California, 90033, United States

  • Investigational Site Number 840008

    Rochester, Minnesota, 55905, United States

  • Investigational Site Number 840009

    Newark, New Jersey, 07112, United States

  • Investigational Site Number 840012

    La Jolla, California, 92093, United States

  • Investigational Site Number 840013

    Baton Rouge, Louisiana, 70808, United States

  • Investigational Site Number 840014

    Scottsdale, Arizona, 85259-5499, United States

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