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NCT03441113Active, not recruitingPhase 2

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)

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

This is an extended-access, long-term safety study for participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) who have not experienced progression of disease and who have tolerated momelotinib (MMB) treatment while participating in previous MMB clinical trials (GS-US-352-0101 \[NCT01969838\], GS-US-352-1214 \[NCT02101268\], GS-US-352-1154 \[NCT02124746\] and SRA-MMB-301 \[NCT04173494\]). Participants in all cohorts continuing MMB treatment will discontinue MMB from the previous study and initiate MMB in this study at the same dose they were receiving in the previous study. Following the final data cut-off date, the study may move into the post analysis continuation of treatment (PACT) phase in which participants will continue to receive MMB and will be monitored and receive follow-up care in accordance with standard local clinical practice.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
237 (actual)
First submitted
15 Feb 2018
Start date
3 May 2018
Primary completion date
11 Dec 2026
Lead sponsor
GlaxoSmithKline
NCT number
NCT03441113
EU CT number
2023-508018-41-00
EudraCT number
2017-004350-42

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 237
  • From 3 May 2018 to the primary completion date, 11 Dec 2026
  • 80 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Incomplete recovery from major surgery prior to Day 1 of this study

Other illness

  • Known hypersensitivity to MMB, its metabolites, or formulation excipients
  • Known positive status for human immunodeficiency virus (HIV)
  • Known chronic active or acute viral hepatitis A, B, or C infection

Other

  • Pregnant or lactating females
  • Presence of greater than or equal to (\>=) Grade 3 (CTCAE Version 4.03) peripheral neuropathy

Who the study is looking for

  • Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
  • Did not discontinue treatment with MMB for any reason while enrolled in Studies GS US 352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
  • A negative serum or urine pregnancy test is required for female participants of childbearing potential
  • Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • Any Grade 3 or 4 (common terminology criteria for adverse events \[CTCAE\] Version 4.03) non-hematologic toxicity in the prior study that the Investigator considers related to previous MMB use must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
  • Any AE requiring MMB interruption during the prior study must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
  • Ability and agreement to attend protocol-specified visits at the study site
  • Able to comprehend and willing to sign the informed consent form

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (80)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
GSK Investigational Site
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LinzAustriaUnknown status
GSK Investigational Site
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ViennaAustriaUnknown status
GSK Investigational Site
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Bedford ParkAustraliaUnknown status
GSK Investigational Site
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FrankstonAustraliaUnknown status
GSK Investigational Site
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MelbourneAustraliaUnknown status
GSK Investigational Site
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PerthAustraliaUnknown status
GSK Investigational Site
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South BrisbaneAustraliaUnknown status
Het Ziekenhuisnetwerk Antwerpen
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AntwerpBelgiumActive, not recruiting
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumActive, not recruiting
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
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SofiyaBulgariaActive, not recruiting
GSK Investigational Site
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MontrealCanadaUnknown status
GSK Investigational Site
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TorontoCanadaUnknown status
Universitaetsklinikum Aachen AöR
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AachenGermanyActive, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyActive, not recruiting
Aalborg University Hospital
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AalborgDenmarkActive, not recruiting
Ceim Hospital Universitari Germans Trias I Pujol
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Complejo Hospitalario QuirónSalud
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ZaragozaSpainActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Groupe D’Etude Des Lymphomes De L’Adulte
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Pierre Benite CedexFranceCompleted
GSK Investigational Site
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AirdrieUnited KingdomUnknown status
GSK Investigational Site
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BristolUnited KingdomUnknown status
GSK Investigational Site
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CardiffUnited KingdomUnknown status
GSK Investigational Site
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LondonUnited KingdomUnknown status
GSK Investigational Site
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OxfordUnited KingdomUnknown status
University of Debrecen
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DebrecenHungaryActive, not recruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryActive, not recruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryActive, not recruiting
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
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TatabányaHungaryActive, not recruiting
GSK Investigational Site
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AfulaIsraelUnknown status
GSK Investigational Site
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AshkelonIsraelUnknown status
GSK Investigational Site
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HaifaIsraelUnknown status
GSK Investigational Site
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JerusalemIsraelUnknown status
GSK Investigational Site
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Kfar SabaIsraelUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scienti
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BolognaItalyActive, not recruiting
Careggi University Hospital
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FlorenceItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Azienda Ospedaliera S Gerardo Di Monza Laboratorio Per La Terapia Cellulare E Genica Stefano Verri
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MonzaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyActive, not recruiting
IRCCS Centro Di Riferimento Oncologico Della Basilicata
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Rionero in VultureItalyActive, not recruiting
Universita' Degli Studi Di Roma La Sapienza
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RomeItalyActive, not recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
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TurinItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyActive, not recruiting
GSK Investigational Site
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BusanSouth KoreaUnknown status
GSK Investigational Site
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DaeguSouth KoreaUnknown status
GSK Investigational Site
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SeoulSouth KoreaUnknown status
GSK Investigational Site
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MaastrichtNetherlandsUnknown status
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
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BrzozówPolandActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandActive, not recruiting
Szpital Wojewodzki W Opolu Sp. z o.o.
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OpolePolandActive, not recruiting
Wielospecjalistyczny Szpital Miejski Im. Jozefa Strusia Z Zakladem Opiekunczo Leczniczym. Samodzielny Publiczny Zaklad Opieki Zdrowotnej Z Siedziba W Poznaniu Przy Ul. Szwajcarskiej 3
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PoznanPolandActive, not recruiting
Onco Card S.R.L.
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BrasovRomaniaActive, not recruiting
Spitalul Clinic Colțea
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BucharestRomaniaActive, not recruiting
Spitalul Clinic Municipal Filantropia Craiova
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CraiovaRomaniaActive, not recruiting
GSK Investigational Site
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SingaporeSingaporeUnknown status
GSK Investigational Site
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Kaohsiung CityTaiwanUnknown status
GSK Investigational Site
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TaipeiTaiwanUnknown status
GSK Investigational Site
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TaoyuanTaiwanUnknown status
GSK Investigational Site
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AtlantaUnited StatesUnknown status
GSK Investigational Site
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AuroraUnited StatesUnknown status
GSK Investigational Site
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BaltimoreUnited StatesUnknown status
GSK Investigational Site
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BostonUnited StatesUnknown status
GSK Investigational Site
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ClevelandUnited StatesUnknown status
GSK Investigational Site
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HackensackUnited StatesUnknown status
GSK Investigational Site
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JacksonvilleUnited StatesUnknown status
GSK Investigational Site
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PortlandUnited StatesUnknown status
GSK Investigational Site
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RochesterUnited StatesUnknown status
GSK Investigational Site
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ScottsdaleUnited StatesUnknown status
GSK Investigational Site
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StanfordUnited StatesUnknown status
GSK Investigational Site
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St LouisUnited StatesUnknown status
GSK Investigational Site
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TampaUnited StatesUnknown status
GSK Investigational Site
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The BronxUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.