Extended Access of Momelotinib in Adults With Myelofibrosis

April 15, 2026 updated by: GlaxoSmithKline

Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
237

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • GSK Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5000
        • GSK Investigational Site
    • Victoria
      • Frankston, Victoria, Australia, 31 99
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3050
        • GSK Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • GSK Investigational Site
  • Austria
      • Linz, Austria, 4020
        • GSK Investigational Site
      • Vienna, Austria, 1090
        • GSK Investigational Site
  • Belgium
      • Antwerp, Belgium, 2030
        • GSK Investigational Site
      • Bruges, Belgium, 8000
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • GSK Investigational Site
      • Rousse, Bulgaria, 7002
        • GSK Investigational Site
      • Sofia, Bulgaria, 1756
        • GSK Investigational Site
      • Sofia, Bulgaria, 01431
        • GSK Investigational Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H3T 1E2
        • GSK Investigational Site
  • Denmark
      • Aalborg, Denmark, 9000
        • GSK Investigational Site
      • Herlev, Denmark, 2100
        • GSK Investigational Site
  • France
      • Le Mans, France, 72037
        • GSK Investigational Site
      • Lille, France, 13273
        • GSK Investigational Site
      • Marseille, France, 13273
        • GSK Investigational Site
      • Paris, France, 75475
        • GSK Investigational Site
      • Pessac, France, 33604
        • GSK Investigational Site
      • Pierre-Bénite, France, 69495
        • GSK Investigational Site
      • Toulouse, France, 31059
        • GSK Investigational Site
  • Germany
      • Aachen, Germany, 52074
        • GSK Investigational Site
      • Cologne, Germany, 50937
        • GSK Investigational Site
      • Dresden, Germany, 01307
        • GSK Investigational Site
      • Halle, Germany, 06120
        • GSK Investigational Site
      • Leipzig, Germany, 04103
        • GSK Investigational Site
      • Lübeck, Germany, 79106
        • GSK Investigational Site
      • Mainz, Germany, 55131
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1083
        • GSK Investigational Site
      • Budapest, Hungary, 1097
        • GSK Investigational Site
      • Debrecen, Hungary, 4032
        • GSK Investigational Site
      • Győr, Hungary, 9024
        • GSK Investigational Site
      • Kaposvár, Hungary, 7400
        • GSK Investigational Site
      • Nyíregyháza, Hungary, 4400
        • GSK Investigational Site
      • Tatabánya, Hungary, 2800
        • GSK Investigational Site
  • Israel
      • Afula, Israel, 18101
        • GSK Investigational Site
      • Ashkelon, Israel, 7830604
        • GSK Investigational Site
      • Haifa, Israel, 3436212
        • GSK Investigational Site
      • Jerusalem, Israel, 9112001
        • GSK Investigational Site
      • Kfar Saba, Israel, 44281
        • GSK Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • GSK Investigational Site
      • Florence, Italy, 50134
        • GSK Investigational Site
      • Genova, Italy, 16132
        • GSK Investigational Site
      • Milan, Italy, 20122
        • GSK Investigational Site
      • Monza, Italy, 20900
        • GSK Investigational Site
      • Naples, Italy, 80131
        • GSK Investigational Site
      • Pesaro, Italy, 61122
        • GSK Investigational Site
      • Rionero in Vulture PZ, Italy, 85028
        • GSK Investigational Site
      • Roma, Italy, 00161
        • GSK Investigational Site
      • Torino, Italy, 10126
        • GSK Investigational Site
      • Torino, Italy, 10128
        • GSK Investigational Site
      • Verona, Italy, 37134
        • GSK Investigational Site
  • Netherlands
      • Maastricht, Netherlands, 6229 ER
        • GSK Investigational Site
  • Poland
      • Brzozów, Poland, 36-200
        • GSK Investigational Site
      • Chorzów, Poland, 41-500
        • GSK Investigational Site
      • Gdansk, Poland, 80-214
        • GSK Investigational Site
      • Krakow, Poland, 30-688
        • GSK Investigational Site
      • Lublin, Poland, 20-081
        • GSK Investigational Site
      • Opole, Poland, 45-061
        • GSK Investigational Site
      • Poznan, Poland, 60-631
        • GSK Investigational Site
  • Romania
      • Brasov, Romania, 500152
        • GSK Investigational Site
      • Bucharest, Romania, 022328
        • GSK Investigational Site
      • Bucharest, Romania, 030171
        • GSK Investigational Site
      • Cluj-Napoca, Romania, 400124
        • GSK Investigational Site
      • Craiova, Romania, 200143
        • GSK Investigational Site
      • Iași, Romania, 700111
        • GSK Investigational Site
  • Singapore
      • Singapore, Singapore, 169608
        • GSK Investigational Site
      • Singapore, Singapore, 188770
        • GSK Investigational Site
  • South Korea
      • Busan, South Korea, 48108
        • GSK Investigational Site
      • Daegu, South Korea, 700-721
        • GSK Investigational Site
      • Seoul, South Korea, 03080
        • GSK Investigational Site
      • Seoul, South Korea, 03722
        • GSK Investigational Site
      • Seoul, South Korea, 135-710
        • GSK Investigational Site
      • Seoul, South Korea, 137-701
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 08003
        • GSK Investigational Site
      • Barcelona, Spain, 08916
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Madrid, Spain, 28222
        • GSK Investigational Site
      • Pamplona, Spain, 31008
        • GSK Investigational Site
      • Zaragoza, Spain, 50012
        • GSK Investigational Site
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • GSK Investigational Site
      • Kaohsiung City, Taiwan, 833
        • GSK Investigational Site
      • Taipei, Taiwan, 100
        • GSK Investigational Site
      • Taoyuan District, Taiwan, 333
        • GSK Investigational Site
  • United Kingdom
      • Airdrie, United Kingdom, ML6 0JS
        • GSK Investigational Site
      • Bristol, United Kingdom, BS2 8ED
        • GSK Investigational Site
      • Cardiff, United Kingdom, CF14 4XW
        • GSK Investigational Site
      • London, United Kingdom, W12 0HS
        • GSK Investigational Site
      • Oxford, United Kingdom, OX3 7LE
        • GSK Investigational Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 53226
        • GSK Investigational Site
    • California
      • Orange, California, United States, 97239
        • GSK Investigational Site
      • Stanford, California, United States, 94305-5821
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • GSK Investigational Site
      • Tampa, Florida, United States, 33612
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21229-5299
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • GSK Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • GSK Investigational Site
    • Missouri
      • St Louis, Missouri, United States, 63130
        • GSK Investigational Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • GSK Investigational Site
    • New York
      • The Bronx, New York, United States, 10467
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Cohort 1: Study GS-US-352-0101
Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-0101 until MMB receives regulatory approval and is commercially available, or development of the product ceases.
Drug: MMB
Tablet(s) administered orally once daily
Other Names:
  • GS-0387
  • CYT387
Other: Cohort 2: Study GS-US-352-1214
Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1214 until MMB receives regulatory approval and is commercially available, or development of the product ceases.
Drug: MMB
Tablet(s) administered orally once daily
Other Names:
  • GS-0387
  • CYT387
Other: Cohort 3: Study GS-US-352-1154
Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1154 until MMB receives regulatory approval and is commercially available, or development of the product ceases..
Drug: MMB
Tablet(s) administered orally once daily
Other Names:
  • GS-0387
  • CYT387
Other: Cohort 4: Study SRA-MMB-301
Participants will continue to receive the same dosage regimen as in the previous MMB study SRA-MMB-301 until MMB receives regulatory approval and is commercially available, or development of the product ceases.
Drug: MMB
Tablet(s) administered orally once daily
Other Names:
  • GS-0387
  • CYT387

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants Who Had Access to, and Received the Intervention
Time Frame: Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.
Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 219627 (Other Identifier: GlaxoSmithKline)
  • SRA-MMB-4365 (Other Identifier: Sierra Oncology, Inc.)
  • 2017-004350-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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