NeoplasmsPhase 2NCT03441113

Extended Access of Momelotinib in Adults With Myelofibrosis

A Phase 2 study testing MMB in people with Neoplasms and Post-polycythemia Vera Myelofibrosis (Post-PV MF), run by GlaxoSmithKline at 112 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms, Post-polycythemia Vera Myelofibrosis (Post-PV MF), Primary Myelofibrosis (PMF)
What is being tested?: MMB
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 237 participants
Where: 112 sitesin 20 countries
Study dates: 3 May 2018to 11 Dec 2026
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Known hypersensitivity to MMB, its metabolites, or formulation excipients
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial locations and contacts

112 sites in 20 countries.

Country

City, postcode or hospital

112 sites in 20 countries

United States14 sites

GSK Investigational Site
Atlanta, Georgia, 30322
GSK Investigational Site
Aurora, Colorado, 80045
GSK Investigational Site
Baltimore, Maryland, 21229-5299
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Cleveland, Ohio, 44195
GSK Investigational Site
Hackensack, New Jersey, 07601
GSK Investigational Site
Jacksonville, Florida, 32224
GSK Investigational Site
Orange, California, 97239
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
Scottsdale, Arizona, 53226
GSK Investigational Site
St Louis, Missouri, 63130
GSK Investigational Site
Stanford, California, 94305-5821
GSK Investigational Site
Tampa, Florida, 33612
GSK Investigational Site
The Bronx, New York, 10467

Other trials in United States

Italy12 sites

GSK Investigational Site
Bologna, 40138
GSK Investigational Site
Florence, 50134
GSK Investigational Site
Genova, 16132
GSK Investigational Site
Milan, 20122
GSK Investigational Site
Monza, 20900
GSK Investigational Site
Naples, 80131
GSK Investigational Site
Pesaro, 61122
GSK Investigational Site
Rionero in Vulture PZ, 85028
GSK Investigational Site
Roma, 00161
GSK Investigational Site
Torino, 10126
GSK Investigational Site
Torino, 10128
GSK Investigational Site
Verona, 37134

Other trials in Italy

Spain8 sites

GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08916
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28222
GSK Investigational Site
Pamplona, 31008
GSK Investigational Site
Zaragoza, 50012

Other trials in Spain

France7 sites

GSK Investigational Site
Le Mans, 72037
GSK Investigational Site
Lille, 13273
GSK Investigational Site
Marseille, 13273
GSK Investigational Site
Paris, 75475
GSK Investigational Site
Pessac, 33604
GSK Investigational Site
Pierre-Bénite, 69495
GSK Investigational Site
Toulouse, 31059

Other trials in France

Germany7 sites

GSK Investigational Site
Aachen, 52074
GSK Investigational Site
Cologne, 50937
GSK Investigational Site
Dresden, 01307
GSK Investigational Site
Halle, 06120
GSK Investigational Site
Leipzig, 04103
GSK Investigational Site
Lübeck, 79106
GSK Investigational Site
Mainz, 55131

Other trials in Germany

Hungary7 sites

GSK Investigational Site
Budapest, 1083
GSK Investigational Site
Budapest, 1097
GSK Investigational Site
Debrecen, 4032
GSK Investigational Site
Győr, 9024
GSK Investigational Site
Kaposvár, 7400
GSK Investigational Site
Nyíregyháza, 4400
GSK Investigational Site
Tatabánya, 2800

Other trials in Hungary

Poland7 sites

GSK Investigational Site
Brzozów, 36-200
GSK Investigational Site
Chorzów, 41-500
GSK Investigational Site
Gdansk, 80-214
GSK Investigational Site
Krakow, 30-688
GSK Investigational Site
Lublin, 20-081
GSK Investigational Site
Opole, 45-061
GSK Investigational Site
Poznan, 60-631

Other trials in Poland

Australia6 sites

GSK Investigational Site
Bedford Park, South Australia, 5000
GSK Investigational Site
Frankston, Victoria, 31 99
GSK Investigational Site
Melbourne, Victoria, 3004
GSK Investigational Site
Melbourne, Victoria, 3050
GSK Investigational Site
Perth, Western Australia, 6000
GSK Investigational Site
South Brisbane, Queensland, 4101

Other trials in Australia

Romania6 sites

GSK Investigational Site
Brasov, 500152
GSK Investigational Site
Bucharest, 022328
GSK Investigational Site
Bucharest, 030171
GSK Investigational Site
Cluj-Napoca, 400124
GSK Investigational Site
Craiova, 200143
GSK Investigational Site
Iași, 700111

Other trials in Romania

South Korea6 sites

GSK Investigational Site
Busan, 48108
GSK Investigational Site
Daegu, 700-721
GSK Investigational Site
Seoul, 03080
GSK Investigational Site
Seoul, 03722
GSK Investigational Site
Seoul, 135-710
GSK Investigational Site
Seoul, 137-701

Other trials in South Korea

Israel5 sites

GSK Investigational Site
Afula, 18101
GSK Investigational Site
Ashkelon, 7830604
GSK Investigational Site
Haifa, 3436212
GSK Investigational Site
Jerusalem, 9112001
GSK Investigational Site
Kfar Saba, 44281

Other trials in Israel

United Kingdom5 sites

GSK Investigational Site
Airdrie, ML6 0JS
GSK Investigational Site
Bristol, BS2 8ED
GSK Investigational Site
Cardiff, CF14 4XW
GSK Investigational Site
London, W12 0HS
GSK Investigational Site
Oxford, OX3 7LE

Other trials in United Kingdom

Belgium4 sites

GSK Investigational Site
Antwerp, 2030
GSK Investigational Site
Bruges, 8000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4000

Other trials in Belgium

Bulgaria4 sites

GSK Investigational Site
Pleven, 5800
GSK Investigational Site
Rousse, 7002
GSK Investigational Site
Sofia, 01431
GSK Investigational Site
Sofia, 1756

Other trials in Bulgaria

Taiwan4 sites

GSK Investigational Site
Kaohsiung City, 807
GSK Investigational Site
Kaohsiung City, 833
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taoyuan, 333

Other trials in Taiwan

Canada3 sites

GSK Investigational Site
Montreal, Quebec, H3H 2R9
GSK Investigational Site
Montreal, Quebec, H3T 1E2
GSK Investigational Site
Toronto, Ontario, M5G 2M9

Other trials in Canada

Austria2 sites

GSK Investigational Site
Linz, 4020
GSK Investigational Site
Vienna, 1090

Other trials in Austria

Denmark2 sites

GSK Investigational Site
Aalborg, 9000
GSK Investigational Site
Herlev, 2100

Other trials in Denmark

Singapore2 sites

GSK Investigational Site
Singapore, 169608
GSK Investigational Site
Singapore, 188770

Other trials in Singapore

Netherlands1 site

GSK Investigational Site
Maastricht, 6229 ER

Other trials in Netherlands

About this study

Official title: 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.

Conditions: Neoplasms, Post-polycythemia Vera Myelofibrosis (Post-PV MF), Primary Myelofibrosis (PMF), Post-essential Thrombocythemia Myelofibrosis (Post-ET MF), Primary Myelofibrosis
Being tested: MMB
Medical subject headings: Neoplasms, Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MMBDrug
Also called GS-0387, CYT387
Tablet(s) administered orally once daily

Study groups in NCT03441113
Study group	Role	What they receive
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. Receives: 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. Receives: 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.. Receives: 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. Receives: Drug: MMB

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Had Access to, and Received the Intervention
Measured: Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 201811 Dec 2026

First posted22 Feb 2018
Study start3 May 2018
Primary completion11 Dec 2026 (estimated)
Study completion11 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 237 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03441113
Sponsor's protocol ID: 219627
Other IDs: 2017-004350-42, SRA-MMB-4365, 219627, 2017
Status last verified: Jun 2026
First submitted: 15 Feb 2018
Last updated: 18 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 37517413
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.
PubMed 37042865