Extended Access of Momelotinib in Adults With Myelofibrosis

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: Active, not recruiting
• Conditions: Neoplasms; Primary Myelofibrosis; Primary Myelofibrosis (PMF); Post-polycythemia Vera Myelofibrosis (Post-PV MF); Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
• Intervention / Treatment: Drug: MMB

• Study Type: Interventional
• Enrollment (Actual): 237
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Number of Participants Who Had Access to, and Received the Intervention	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

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• Gerds AT, Verstovsek S, Vannucchi AM, Al-Ali HK, Lavie D, Kuykendall AT, Grosicki S, Iurlo A, Goh YT, Lazaroiu MC, Egyed M, Fox ML, McLornan D, Perkins A, Yoon SS, Gupta V, Kiladjian JJ, Granacher N, Lee SE, Ocroteala L, Passamonti F, Harrison CN, Oh S, Klencke BJ, Yu J, Donahue R, Kawashima J, Mesa R. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis previously treated with a JAK inhibitor (MOMENTUM): an updated analysis of an international, double-blind, randomised phase 3 study. Lancet Haematol. 2023 Sep;10(9):e735-e746. doi: 10.1016/S2352-3026(23)00174-6. Epub 2023 Jul 27.
• Verstovsek S, Mesa R, Gupta V, Lavie D, Dubruille V, Cambier N, Platzbecker U, Hus M, Xicoy B, Oh ST, Kiladjian JJ, Vannucchi AM, Gerds A, Egyed M, Mayer J, Sacha T, Kawashima J, Morris M, Huang M, Harrison C. Momelotinib long-term safety and survival in myelofibrosis: integrated analysis of phase 3 randomized controlled trials. Blood Adv. 2023 Jul 25;7(14):3582-3591. doi: 10.1182/bloodadvances.2022009311.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2026

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Hemic and Lymphatic Diseases; Neoplasms; Primary Myelofibrosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide
• Other Study ID 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