Extended Access of Momelotinib in Adults With Myelofibrosis

NCT03441113 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: 2196272017-004350-42SRA-MMB-4365
• Study Type: interventional
• Target: 237
• Locations: 19 countries
• Sites: 110

Brief Summary

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.

Conditions

Neoplasms; Primary Myelofibrosis (PMF); Post-essential Thrombocythemia Myelofibrosis (Post-ET MF); Post-polycythemia Vera Myelofibrosis (Post-PV MF); Primary Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Cohort 1: Study GS-US-352-0101

OTHER

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

Cohort 2: Study GS-US-352-1214

OTHER

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

Cohort 3: Study GS-US-352-1154

OTHER

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

Cohort 4: Study SRA-MMB-301

OTHER

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

Interventions

MMB DRUG

Tablet(s) administered orally once daily

Also known as: GS-0387, CYT387

Cohort 1: Study GS-US-352-0101; Cohort 2: Study GS-US-352-1214; Cohort 3: Study GS-US-352-1154; Cohort 4: Study SRA-MMB-301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known hypersensitivity to MMB, its metabolites, or formulation excipients

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (112)

GSK Investigational Site

Scottsdale, Arizona, 53226, United States

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Orange, California, 97239, United States

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Stanford, California, 94305-5821, United States

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Aurora, Colorado, 80045, United States

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Jacksonville, Florida, 32224, United States

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Tampa, Florida, 33612, United States

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Atlanta, Georgia, 30322, United States

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Baltimore, Maryland, 21229-5299, United States

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Boston, Massachusetts, 02215, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63130, United States

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Hackensack, New Jersey, 07601, United States

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The Bronx, New York, 10467, United States

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Cleveland, Ohio, 44195, United States

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South Brisbane, Queensland, 4101, Australia

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Bedford Park, South Australia, 5000, Australia

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Frankston, Victoria, 31 99, Australia

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Melbourne, Victoria, 3004, Australia

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Melbourne, Victoria, 3050, Australia

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Perth, Western Australia, 6000, Australia

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Linz, 4020, Austria

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Vienna, 1090, Austria

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Antwerp, 2030, Belgium

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Bruges, 8000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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GSK Investigational Site

Pleven, 5800, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 01431, Bulgaria

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Sofia, 1756, Bulgaria

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GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H3H 2R9, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Aalborg, 9000, Denmark

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Herlev, 2100, Denmark

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Le Mans, 72037, France

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Lille, 13273, France

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Marseille, 13273, France

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Paris, 75475, France

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Pessac, 33604, France

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Pierre-Bénite, 69495, France

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Toulouse, 31059, France

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Aachen, 52074, Germany

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Cologne, 50937, Germany

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Dresden, 01307, Germany

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Halle, 06120, Germany

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Leipzig, 04103, Germany

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Lübeck, 79106, Germany

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Mainz, 55131, Germany

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Budapest, 1083, Hungary

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Budapest, 1097, Hungary

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Debrecen, 4032, Hungary

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Győr, 9024, Hungary

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Kaposvár, 7400, Hungary

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Nyíregyháza, 4400, Hungary

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Tatabánya, 2800, Hungary

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Afula, 18101, Israel

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Ashkelon, 7830604, Israel

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Haifa, 3436212, Israel

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Jerusalem, 9112001, Israel

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Kfar Saba, 44281, Israel

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Bologna, 40138, Italy

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Florence, 50134, Italy

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Genova, 16132, Italy

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Milan, 20122, Italy

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Monza, 20900, Italy

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Naples, 80131, Italy

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Pesaro, 61122, Italy

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Rionero in Vulture PZ, 85028, Italy

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Roma, 00161, Italy

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Torino, 10126, Italy

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Torino, 10128, Italy

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Verona, 37134, Italy

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Maastricht, 6229 ER, Netherlands

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Brzozów, 36-200, Poland

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Chorzów, 41-500, Poland

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Gdansk, 80-214, Poland

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Krakow, 30-688, Poland

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Lublin, 20-081, Poland

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Opole, 45-061, Poland

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Poznan, 60-631, Poland

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Brasov, 500152, Romania

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Bucharest, 022328, Romania

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Bucharest, 030171, Romania

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GSK Investigational Site

Cluj-Napoca, 400124, Romania

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Craiova, 200143, Romania

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GSK Investigational Site

Iași, 700111, Romania

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Singapore, 169608, Singapore

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Singapore, 188770, Singapore

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GSK Investigational Site

Busan, 48108, South Korea

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GSK Investigational Site

Daegu, 700-721, South Korea

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GSK Investigational Site

Seoul, 03080, South Korea

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GSK Investigational Site

Seoul, 03722, South Korea

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GSK Investigational Site

Seoul, 135-710, South Korea

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GSK Investigational Site

Seoul, 137-701, South Korea

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GSK Investigational Site

Barcelona, 08003, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Barcelona, 08916, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28222, Spain

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GSK Investigational Site

Pamplona, 31008, Spain

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GSK Investigational Site

Zaragoza, 50012, Spain

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GSK Investigational Site

Kaohsiung City, 807, Taiwan

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GSK Investigational Site

Kaohsiung City, 833, Taiwan

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GSK Investigational Site

Taipei, 100, Taiwan

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GSK Investigational Site

Taoyuan District, 333, Taiwan

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GSK Investigational Site

Airdrie, ML6 0JS, United Kingdom

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GSK Investigational Site

Bristol, BS2 8ED, United Kingdom

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Cardiff, CF14 4XW, United Kingdom

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GSK Investigational Site

London, W12 0HS, United Kingdom

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GSK Investigational Site

Oxford, OX3 7LE, United Kingdom

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Related Publications (2)

• 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.

  PMID: 37517413 DERIVED

• 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.

  PMID: 37042865 DERIVED

MeSH Terms

Conditions

Neoplasms; Primary Myelofibrosis

Interventions

N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: May 3, 2018
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (12); AU (6); HU (7); KR (6); FR (7); DE (7); SG (2); BU (4); GB (5); DK (2); US (14); BE (4); IL (5); RO (6); CA (3); ES (8); TW (4); PL (7); NL (1)