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
- Diseases
- Myeloproliferative neoplasms
- 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
Sites (80)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Het Ziekenhuisnetwerk Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Active, not recruiting |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Active, not recruiting |
| Specialized Hospital For Active Treatment Of Hematological Diseases EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Active, not recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Active, not recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Active, not recruiting |
| Ceim Hospital Universitari Germans Trias I Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Complejo Hospitalario QuirónSalud Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| Groupe D’Etude Des Lymphomes De L’Adulte Coordinator of this site? Confirm its status | Pierre Benite Cedex | France | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Airdrie | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Active, not recruiting |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Active, not recruiting |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz Coordinator of this site? Confirm its status | Tatabánya | Hungary | Active, not recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ashkelon | Israel | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scienti Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera S Gerardo Di Monza Laboratorio Per La Terapia Cellulare E Genica Stefano Verri Coordinator of this site? Confirm its status | Monza | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| IRCCS Centro Di Riferimento Oncologico Della Basilicata Coordinator of this site? Confirm its status | Rionero in Vulture | Italy | Active, not recruiting |
| Universita' Degli Studi Di Roma La Sapienza Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Active, not recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Coordinator of this site? Confirm its status | Brzozów | Poland | Active, not recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Szpital Wojewodzki W Opolu Sp. z o.o. Coordinator of this site? Confirm its status | Opole | Poland | Active, 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 Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Onco Card S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Active, not recruiting |
| Spitalul Clinic Colțea Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic Municipal Filantropia Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Active, not recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.