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New hope for myelofibrosis patients who stop responding to standard therapy

NCT ID NCT01523171

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 2 trial tests an experimental drug called SAR302503 in people with myelofibrosis who have already been treated with ruxolitinib. The main goal is to see if the drug can shrink the spleen by at least 35% after six months of daily oral capsules. The study also tracks whether symptoms like night sweats and belly discomfort improve. Participants have intermediate- or high-risk myelofibrosis, including forms that started after polycythemia vera or essential thrombocythemia.

What this could mean

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

Active substance
an experimental drug called SAR302503
What this could lead to
If successful, this could offer a new treatment option for people with myelofibrosis whose disease no longer responds to ruxolitinib.
What could go wrong
This is a mid-stage trial with a small number of participants and no comparison group, so results may not confirm benefit. The drug may also have side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

97 people

The number who actually took part.

Started

Apr 2012

Finished

Apr 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 PMF or Post-PV MF or Post-ET MF, according to the 2008 World Health Organization and IWG-MRT response criteria * Subjects who previously received Ruxolitinib treatment for PMF or Post-PV MF or Post-ET MF or PV or ET for at least 14 days (exposure of \<14 days is allowed for subjects who discontinued Ruxolitinib due to intolerability or allergy) and discontinued the treatment for at least 14 days prior to the first dose of SAR302503 * MF classified as Intermediate-1 with symptoms, Intermediate-2 or high-risk by Dynamic International Prognostic Scoring System (Passamonti et al., Blood 2010) * Spleen ≥5 cm below costal margin as measured by palpation * Male and female subjects ≥18 years of age * Signed written informed consent Exclusion criteria: * Splenectomy * Eastern Cooperative Oncology Group (ECOG) performance status of \>2 before the first dose of SAR302503 at Cycle 1 Day1 * The following laboratory values within 14 days prior to the initiation of SAR302503: * 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 * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN * Total bilirubin ≥3.0 x ULN * Subjects with total bilirubin between 1.5-3.0 x ULN must be excluded if the direct bilirubin fraction is ≥25% of the total * Subjects with known active (acute or chronic) Hepatitis A, B, or C; and Hepatitis B and C carriers * Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis \[NASH\]) * Subjects with any other prior malignancies are not eligible, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which subject has been disease-free for at least 5 years * Any chemotherapy, 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 SAR302503; darbepoetin use within 28 days prior to initiation of SAR302503.The only chemotherapy allowed will be hydroxyurea within 1 day prior to initiation of SAR302503 * Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of SAR302503 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 040001

    Vienna, 1090, Austria

  • Investigational Site Number 040002

    Salzburg, 5020, Austria

  • Investigational Site Number 056002

    Antwerp, 2060, Belgium

  • Investigational Site Number 056003

    Leuven, 3000, Belgium

  • Investigational Site Number 124001

    Toronto, M5G 2M9, Canada

  • Investigational Site Number 250001

    Marseille, 13273, France

  • Investigational Site Number 250002

    Paris, 75475, France

  • Investigational Site Number 250003

    Nîmes, 30029, France

  • Investigational Site Number 250004

    Toulouse, 31000, France

  • Investigational Site Number 250006

    Paris, 75571, France

  • Investigational Site Number 276001

    Mannheim, 68167, Germany

  • Investigational Site Number 276003

    Frankfurt am Main, 60590, Germany

  • Investigational Site Number 276005

    Ulm, 89081, Germany

  • Investigational Site Number 276006

    Magdeburg, 39120, Germany

  • Investigational Site Number 276007

    Leipzig, 04103, Germany

  • Investigational Site Number 380001

    Milan, 20122, Italy

  • Investigational Site Number 380002

    Roma, 00161, Italy

  • Investigational Site Number 380003

    Varese, 21100, Italy

  • Investigational Site Number 380004

    Florence, 50134, Italy

  • Investigational Site Number 528001

    Nijmegen, 6525 GA, Netherlands

  • Investigational Site Number 528002

    Amsterdam, 1081 HV, Netherlands

  • Investigational Site Number 528003

    Maastricht, 6229 HX, Netherlands

  • Investigational Site Number 724001

    Barcelona, 08036, Spain

  • Investigational Site Number 724002

    Salamanca, 37007, Spain

  • Investigational Site Number 724003

    Majadahonda, 28222, Spain

  • Investigational Site Number 826001

    London, SE1 9RT, United Kingdom

  • Investigational Site Number 840001

    Kansas City, Kansas, 66160-7321, United States

  • Investigational Site Number 840002

    Houston, Texas, 77030, United States

  • Investigational Site Number 840003

    San Francisco, California, 94143, United States

  • Investigational Site Number 840004

    San Francisco, California, 94143, United States

  • Investigational Site Number 840005

    Atlanta, Georgia, 30322, United States

  • Investigational Site Number 840007

    Phoenix, Arizona, 85054, United States

  • Investigational Site Number 840009

    New York, New York, 10021, United States

  • Investigational Site Number 840010

    Ann Arbor, Michigan, 48109-0759, United States

  • Investigational Site Number 840013

    Baltimore, Maryland, 21229, United States

  • Investigational Site Number 840014

    Chicago, Illinois, 60637, United States

  • Investigational Site Number 840015

    Salt Lake City, Utah, 84112-5550, United States

  • Investigational Site Number 840017

    Baltimore, Maryland, 21201, United States

  • Investigational Site Number 840018

    New York, New York, 10032, United States

  • Investigational Site Number 840019

    Middletown, Ohio, 45042, United States

  • Investigational Site Number 840022

    Cleveland, Ohio, 44195, United States

  • Investigational Site Number 840024

    Charleston, South Carolina, 29406, United States

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