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Momelotinib access expanded for myelofibrosis patients in Long-Term safety study

NCT ID NCT03441113

Disease control Sponsor: GlaxoSmithKline 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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study provides extended access to the drug momelotinib for 237 people with a type of bone marrow cancer called myelofibrosis. Participants had already been taking momelotinib in earlier studies and had not seen their disease get worse. The goal is to see how safe the drug is over a longer period and whether it helps people live longer without the disease getting worse.

What this could mean

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

Active substance
momelotinib (a drug taken as a tablet once daily)
What this could lead to
If successful, this could confirm momelotinib as a safe long-term treatment option for people with myelofibrosis, helping control the disease and improve survival.
What could go wrong
This is an extended-access study, not a new treatment test. It only includes people who already tolerated the drug, so results may not apply to all patients. Long-term risks are still being monitored.

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

237 people

The number who actually took part.

Started

May 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

Key Inclusion Criteria: * Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301 * Able to comprehend and willing to sign the informed consent form Key Exclusion Criteria: * Known hypersensitivity to MMB, its metabolites, or formulation excipients NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

neoplasm primary myelofibrosis

As listed by the trial registrant

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

Neoplasms Post-essential thrombocythemia myelofibrosis (post-et MF) Post-polycythemia vera myelofibrosis (post-PV MF) Primary myelofibrosis Primary myelofibrosis (PMF)

Contacts and locations

Locations

  • GSK Investigational Site

    Scottsdale, Arizona, 53226, United States

  • GSK Investigational Site

    Orange, California, 97239, United States

  • GSK Investigational Site

    Stanford, California, 94305-5821, United States

  • GSK Investigational Site

    Aurora, Colorado, 80045, United States

  • GSK Investigational Site

    Jacksonville, Florida, 32224, United States

  • GSK Investigational Site

    Tampa, Florida, 33612, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30322, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21229-5299, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02215, United States

  • GSK Investigational Site

    Rochester, Minnesota, 55905, United States

  • GSK Investigational Site

    St Louis, Missouri, 63130, United States

  • GSK Investigational Site

    Hackensack, New Jersey, 07601, United States

  • GSK Investigational Site

    The Bronx, New York, 10467, United States

  • GSK Investigational Site

    Cleveland, Ohio, 44195, United States

  • GSK Investigational Site

    South Brisbane, Queensland, 4101, Australia

  • GSK Investigational Site

    Bedford Park, South Australia, 5000, Australia

  • GSK Investigational Site

    Frankston, Victoria, 31 99, Australia

  • GSK Investigational Site

    Melbourne, Victoria, 3004, Australia

  • GSK Investigational Site

    Melbourne, Victoria, 3050, Australia

  • GSK Investigational Site

    Perth, Western Australia, 6000, Australia

  • GSK Investigational Site

    Linz, 4020, Austria

  • GSK Investigational Site

    Vienna, 1090, Austria

  • GSK Investigational Site

    Antwerp, 2030, Belgium

  • GSK Investigational Site

    Bruges, 8000, Belgium

  • GSK Investigational Site

    Leuven, 3000, Belgium

  • GSK Investigational Site

    Liège, 4000, Belgium

  • GSK Investigational Site

    Pleven, 5800, Bulgaria

  • GSK Investigational Site

    Rousse, 7002, Bulgaria

  • GSK Investigational Site

    Sofia, 01431, Bulgaria

  • GSK Investigational Site

    Sofia, 1756, Bulgaria

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H3H 2R9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2, Canada

  • GSK Investigational Site

    Aalborg, 9000, Denmark

  • GSK Investigational Site

    Herlev, 2100, Denmark

  • GSK Investigational Site

    Le Mans, 72037, France

  • GSK Investigational Site

    Lille, 13273, France

  • GSK Investigational Site

    Marseille, 13273, France

  • GSK Investigational Site

    Paris, 75475, France

  • GSK Investigational Site

    Pessac, 33604, France

  • GSK Investigational Site

    Pierre-Bénite, 69495, France

  • GSK Investigational Site

    Toulouse, 31059, France

  • GSK Investigational Site

    Aachen, 52074, Germany

  • GSK Investigational Site

    Cologne, 50937, Germany

  • GSK Investigational Site

    Dresden, 01307, Germany

  • GSK Investigational Site

    Halle, 06120, Germany

  • GSK Investigational Site

    Leipzig, 04103, Germany

  • GSK Investigational Site

    Lübeck, 79106, Germany

  • GSK Investigational Site

    Mainz, 55131, Germany

  • GSK Investigational Site

    Budapest, 1083, Hungary

  • GSK Investigational Site

    Budapest, 1097, Hungary

  • GSK Investigational Site

    Debrecen, 4032, Hungary

  • GSK Investigational Site

    Győr, 9024, Hungary

  • GSK Investigational Site

    Kaposvár, 7400, Hungary

  • GSK Investigational Site

    Nyíregyháza, 4400, Hungary

  • GSK Investigational Site

    Tatabánya, 2800, Hungary

  • GSK Investigational Site

    Afula, 18101, Israel

  • GSK Investigational Site

    Ashkelon, 7830604, Israel

  • GSK Investigational Site

    Haifa, 3436212, Israel

  • GSK Investigational Site

    Jerusalem, 9112001, Israel

  • GSK Investigational Site

    Kfar Saba, 44281, Israel

  • GSK Investigational Site

    Bologna, 40138, Italy

  • GSK Investigational Site

    Florence, 50134, Italy

  • GSK Investigational Site

    Genova, 16132, Italy

  • GSK Investigational Site

    Milan, 20122, Italy

  • GSK Investigational Site

    Monza, 20900, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Pesaro, 61122, Italy

  • GSK Investigational Site

    Rionero in Vulture PZ, 85028, Italy

  • GSK Investigational Site

    Roma, 00161, Italy

  • GSK Investigational Site

    Torino, 10126, Italy

  • GSK Investigational Site

    Torino, 10128, Italy

  • GSK Investigational Site

    Verona, 37134, Italy

  • GSK Investigational Site

    Maastricht, 6229 ER, Netherlands

  • GSK Investigational Site

    Brzozów, 36-200, Poland

  • GSK Investigational Site

    Chorzów, 41-500, Poland

  • GSK Investigational Site

    Gdansk, 80-214, Poland

  • GSK Investigational Site

    Krakow, 30-688, Poland

  • GSK Investigational Site

    Lublin, 20-081, Poland

  • GSK Investigational Site

    Opole, 45-061, Poland

  • GSK Investigational Site

    Poznan, 60-631, Poland

  • GSK Investigational Site

    Brasov, 500152, Romania

  • GSK Investigational Site

    Bucharest, 022328, Romania

  • GSK Investigational Site

    Bucharest, 030171, Romania

  • GSK Investigational Site

    Cluj-Napoca, 400124, Romania

  • GSK Investigational Site

    Craiova, 200143, Romania

  • GSK Investigational Site

    Iași, 700111, Romania

  • GSK Investigational Site

    Singapore, 169608, Singapore

  • GSK Investigational Site

    Singapore, 188770, Singapore

  • GSK Investigational Site

    Busan, 48108, South Korea

  • GSK Investigational Site

    Daegu, 700-721, South Korea

  • GSK Investigational Site

    Seoul, 03080, South Korea

  • GSK Investigational Site

    Seoul, 03722, South Korea

  • GSK Investigational Site

    Seoul, 135-710, South Korea

  • GSK Investigational Site

    Seoul, 137-701, South Korea

  • GSK Investigational Site

    Barcelona, 08003, Spain

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08916, Spain

  • GSK Investigational Site

    Madrid, 28034, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28222, Spain

  • GSK Investigational Site

    Pamplona, 31008, Spain

  • GSK Investigational Site

    Zaragoza, 50012, Spain

  • GSK Investigational Site

    Kaohsiung City, 807, Taiwan

  • GSK Investigational Site

    Kaohsiung City, 833, Taiwan

  • GSK Investigational Site

    Taipei, 100, Taiwan

  • GSK Investigational Site

    Taoyuan, 333, Taiwan

  • GSK Investigational Site

    Airdrie, ML6 0JS, United Kingdom

  • GSK Investigational Site

    Bristol, BS2 8ED, United Kingdom

  • GSK Investigational Site

    Cardiff, CF14 4XW, United Kingdom

  • GSK Investigational Site

    London, W12 0HS, United Kingdom

  • GSK Investigational Site

    Oxford, OX3 7LE, United Kingdom

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