Myeloproliferative Neoplasms Clinical Trial

Extended Access of Momelotinib in Adults With Myelofibrosis

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

237

Study ID:

NCT03441113

Recruitment Status:

Active, not recruiting

Sponsor:

GlaxoSmithKline

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There are 136 Locations for this study

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IC Irvine Health
Orange California, 92868, United States
GSK Investigational Site
Stanford California, 94305, United States
Stanford Hospital and Clinics
Stanford California, 94305, United States
GSK Investigational Site
Aurora Colorado, 80045, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
GSK Investigational Site
Jacksonville Florida, 32224, United States
Mayo Clinic Florida
Jacksonville Florida, 32224, United States
GSK Investigational Site
Tampa Florida, 33612, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
GSK Investigational Site
Atlanta Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Northwest Oncology & Hematology - Rolling Meadows
Rolling Meadows Illinois, 60008, United States
GSK Investigational Site
Baltimore Maryland, 21229, United States
Saint Agnes Hospital
Baltimore Maryland, 21229, United States
Dana-Farber Cancer Institute (DFCI)
Boston Massachusetts, 02215, United States
GSK Investigational Site
Boston Massachusetts, 02215, United States
GSK Investigational Site
Rochester Minnesota, 55905, United States
Mayo Clinic - Department of Hematology
Rochester Minnesota, 55905, United States
Washington University School of Medicine Siteman Cancer Center
Saint Louis Missouri, 63110, United States
GSK Investigational Site
Saint Louis Missouri, 63130, United States
GSK Investigational Site
Hackensack New Jersey, 07601, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
GSK Investigational Site
Bronx New York, 10467, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
GSK Investigational Site
Cleveland Ohio, 44195, United States
GSK Investigational Site
Portland Oregon, 97239, United States
GSK Investigational Site
Milwaukee Wisconsin, 53226, United States
Mayo Clinic Building - Phoenix
Milwaukee Wisconsin, 53226, United States
Icon Cancer Care Wesley
Hyde Park Queensland, 4812, Australia
GSK Investigational Site
South Brisbane Queensland, 4101, Australia
Flinders Medical Centre
Adelaide South Australia, 5000, Australia
GSK Investigational Site
Adelaide South Australia, 5000, Australia
GSK Investigational Site
Frankston Victoria, 31 99, Australia
Frankston Hospital
Frankston Victoria, 3199, Australia
GSK Investigational Site
Melbourne Victoria, 3004, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
GSK Investigational Site
Parkville Victoria, 3050, Australia
Peter MacCallum Cancer Centre
Parkville Victoria, 3050, Australia
GSK Investigational Site
Perth Western Australia, 6000, Australia
Royal Perth Hospital
Perth Western Australia, 6160, Australia
Ordensklinikum Linz Elisabethinen
Linz Upper Austria, 4020, Austria
Medizinische Universität Wien
Wien Vienna, 1090, Austria
GSK Investigational Site
Linz , 4020, Austria
GSK Investigational Site
Wien , 1090, Austria
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Brugge West-Vlaanderen, 8000, Belgium
GSK Investigational Site
Antwerpen , 2060, Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp , 2060, Belgium
GSK Investigational Site
Brugge , 8000, Belgium
GSK Investigational Site
Leuven , 3000, Belgium
Universitaire Ziekenhuis Leuven
Leuven , 3000, Belgium
Centre Hospitalier Universitaire de Liège Site Sart Tilman
Liège , 4000, Belgium
GSK Investigational Site
Liège , 4000, Belgium
GSK Investigational Site
Pleven , 5800, Bulgaria
UMHAT Dr. Georgi Stranski EAD
Pleven , 5800, Bulgaria
GSK Investigational Site
Ruse , 7002, Bulgaria
Multiprofile Hospital for Active Treatment Ruse
Ruse , 7002, Bulgaria
GSK Investigational Site
Sofia , 01431, Bulgaria
National Specialized Hospital for Active Treatment of Haematologic Diseases
Sofia , 1431, Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
Sofia , 1431, Bulgaria
GSK Investigational Site
Sofia , 1756, Bulgaria
GSK Investigational Site
Toronto Ontario, M5G 2, Canada
GSK Investigational Site
Montreal Quebec, H3H 2, Canada
GSK Investigational Site
Montreal Quebec, H3T 1, Canada
Research Institute of the McGill University Health Centre
Montréal Quebec, H3H 2, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montréal , H3T 1, Canada
Princess Margaret Cancer Centre
Toronto , M5G 2, Canada
Aalborg University Hospital
Aalborg , 9000, Denmark
Gentofte Hospital
Herlev , 2730, Denmark
GSK Investigational Site
Koebenhavn , 2100, Denmark
GSK Investigational Site
Ålborg , 9000, Denmark
Hopital Saint-Louis
Paris ILE-De-FRANCE, 75475, France
Centre Hospitalier Le Mans
Le Mans Pays De La Loire, 72037, France
GSK Investigational Site
Le Mans Cedex , 72037, France
CHRU Huriez Lille
Lille Cedex , 59020, France
GSK Investigational Site
Marseille CEDEX 9 , 13273, France
Institut Paoli Calmettes
Marseille , 13273, France
GSK Investigational Site
Paris cedex 10 , 75475, France
GSK Investigational Site
Pessac cedex , 33604, France
Hôpital Haut-Lévêque
Pessac Cedex , 33604, France
Centre Hospitalier Lyon Sud
Pierre Bénite Cedex , 69495, France
GSK Investigational Site
Pierre-Bénite cedex , 69495, France
GSK Investigational Site
Toulouse Cedex 9 , 31059, France
Institut Universitaire du Cancer
Toulouse Cedex 9 , 31059, France
GSK Investigational Site
Freiburg Baden-Wuerttemberg, 79106, Germany
GSK Investigational Site
Aachen Nordrhein-Westfalen, 52074, Germany
Universitätsklinikum Aachen
Aachen Nordrhein-Westfalen, 52074, Germany
GSK Investigational Site
Koeln Nordrhein-Westfalen, 50937, Germany
GSK Investigational Site
Mainz Rheinland-Pfalz, 55131, Germany
GSK Investigational Site
Halle Sachsen-Anhalt, 06120, Germany
Universitätsklinikum Halle
Halle Sachsen-Anhalt, 06120, Germany
GSK Investigational Site
Dresden Sachsen, 01307, Germany
GSK Investigational Site
Leipzig Sachsen, 04103, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck Schleswig-Holstein, 23538, Germany
University Hospital of Cologne
Cologne , 50937, Germany
Universitätsklinikum Dresden
Dresden , 01307, Germany
Universitätsklinikum Leipzig
Leipzig , 04103, Germany
Johannes Gutenberg-Universität Mainz
Mainz , 55131, Germany
Petz Aladár Egyetemi Oktató Kórház - Győr
Győr Gyor-Moson-Sopron, 9023, Hungary
Szent Borbála Kórház
Tatabánya Komárom-Esztergom, 2800, Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
Budapest Pest, 1097, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
Nyíregyháza Szabolcs-Szatmár-Bereg, 4400, Hungary
GSK Investigational Site
Budapest , 1083, Hungary
Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia
Budapest , 1083, Hungary
GSK Investigational Site
Budapest , 1097, Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek
Debrecen , 4032, Hungary
GSK Investigational Site
Debrecen , 4032, Hungary
GSK Investigational Site
Győr , 9024, Hungary
GSK Investigational Site
Kaposvár , 7400, Hungary
Somogy Megyei Kaposi Mor Oktató Kórház
Kaposvár , 7400, Hungary
GSK Investigational Site
Nyiregyhaza , 4400, Hungary
GSK Investigational Site
Tatabánya , 2800, Hungary
GSK Investigational Site
Afula , 18101, Israel
Emek Medical Center
Afula , 18341, Israel
Barzilai Medical Center, Hematology Institute
Ashkelon , 78278, Israel
GSK Investigational Site
Ashkelton , 78306, Israel
Carmel Medical Center
Haifa , 34362, Israel
GSK Investigational Site
Haifa , 34362, Israel
GSK Investigational Site
Jerusalem , 91120, Israel
Hadassh Medical Organization
Jerusalem , 91120, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
GSK Investigational Site
Kfar Saba , 44281, Israel
GSK Investigational Site
Rionero In Vulture (Pz) Basilicata, 85028, Italy
GSK Investigational Site
Napoli Campania, 80131, Italy
GSK Investigational Site
Bologna Emilia-Romagna, 40138, Italy
Azienda Ospedaliero - Universitaria Careggi
Firenze Florence, 50134, Italy
GSK Investigational Site
Genova Liguria, 16132, Italy
GSK Investigational Site
Milano Lombardia, 20122, Italy
GSK Investigational Site
Monza (MB) Lombardia, 20900, Italy
Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
Monza Monza E Brianza, 20900, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro Pesaro E Urbino, 61121, Italy
GSK Investigational Site
Torino Piemonte, 10126, Italy
GSK Investigational Site
Firenze Toscana, 50134, Italy
GSK Investigational Site
Torino Trentino-Alto Adige, 10128, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino Turin, 10126, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino Turin, 10128, Italy
GSK Investigational Site
Verona Veneto, 37134, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna , 40138, Italy
Azienda Ospedaliera Universitaria San Martino
Genova , 16132, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli , 80131, Italy
GSK Investigational Site
Pesaro , 61122, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata
Potenza , 85028, Italy
GSK Investigational Site
Roma , 00161, Italy
Umberto I - Policlinico di Roma
Roma , 00161, Italy
Ospedale Policlinico Giambattista Rossi Borgo Roma
Verona , 37134, Italy
Inje University Haeundae Paik Hospital
Busan Busan Gwang'yeogsi [Pusan-Kwangyokshi], 48108, Korea, Republic of
Kyungpook National University Hospital
Daegu Daegu Gwang'yeogsi, 41944, Korea, Republic of
Severance Hospital
Seoul Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03722, Korea, Republic of
GSK Investigational Site
Busan , 48108, Korea, Republic of
GSK Investigational Site
Daegu , 700-7, Korea, Republic of
GSK Investigational Site
Seoul , 03080, Korea, Republic of
GSK Investigational Site
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Catholic University of Korea Seoul Saint Mary's Hospital
Seoul , 06591, Korea, Republic of
GSK Investigational Site
Seoul , 135-7, Korea, Republic of
GSK Investigational Site
Seoul , 137-7, Korea, Republic of
Seoul National University Hospital
Seoul , 3080, Korea, Republic of
Maastricht University Medical Centre
Maastricht Limburg, 6229 , Netherlands
GSK Investigational Site
Maastricht , 6229 , Netherlands
Szpital Wojewódzki w Opolu
Opole Opolskie, 45-06, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów Podkarpacki, 36-20, Poland
Uniwersyteckie Centrum Kliniczne
Gdańsk Pomoskie, 80-95, Poland
GSK Investigational Site
Brzozow , 36-20, Poland
GSK Investigational Site
Chorzow , 41-50, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
Chorzów , 41-50, Poland
GSK Investigational Site
Gdansk , 80-21, Poland
GSK Investigational Site
Krakow , 31-50, Poland
GSK Investigational Site
Lublin , 20-08, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub
Lublin , 20-08, Poland
Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii
Małogoskie , 31-50, Poland
GSK Investigational Site
Opole , 45-06, Poland
GSK Investigational Site
Poznań , 60-63, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego
Poznań , 60-63, Poland
GSK Investigational Site
Brasov , 50015, Romania
Policlinica de Diagnostic Rapid SA
Braşov , 50015, Romania
GSK Investigational Site
Bucharest , 02232, Romania
GSK Investigational Site
Bucharest , 03017, Romania
Spitalul Clinic Coltea
Bucuresti , 03017, Romania
Institutul Clinic Fundeni
Bucuresti , 22328, Romania
GSK Investigational Site
Cluj-Napoca , 40012, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuţă
Cluj-Napoca , 40012, Romania
GSK Investigational Site
Craiova , 20014, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova , 20014, Romania
GSK Investigational Site
Iasi , 70011, Romania
Institutul Regional De Oncologie IASI
Iasi , 70048, Romania
GSK Investigational Site
Singapore , 16960, Singapore
Singapore General Hospital
Singapore , 16960, Singapore
GSK Investigational Site
Singapore , 18877, Singapore
Raffles Hospital
Singapore , 18877, Singapore
Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
GSK Investigational Site
Barcelona , 08003, Spain
Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona , 08003, Spain
GSK Investigational Site
Barcelona , 08035, Spain
GSK Investigational Site
Barcelona , 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 8035, Spain
GSK Investigational Site
Madrid , 28034, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
GSK Investigational Site
Madrid , 28041, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid , 28222, Spain
GSK Investigational Site
Majadahonda (Madrid) , 28222, Spain
Clínica Universidad de Navarra
Pamplona , 31008, Spain
GSK Investigational Site
Pamplona , 31008, Spain
GSK Investigational Site
Zaragoza , 50009, Spain
Hospital de Día Quirónsalud Zaragoza
Zaragoza , 50012, Spain
GSK Investigational Site
Kaohsiung , 807, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan
GSK Investigational Site
Kaohsiung , 833, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , 88301, Taiwan
GSK Investigational Site
Taipei , 100, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan , 333, Taiwan
GSK Investigational Site
Taoyuan , 333, Taiwan
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol England, BS2 8, United Kingdom
GSK Investigational Site
Airdrie Lanarkshire, ML6 0, United Kingdom
NHS Lanarkshire
Airdrie Scotland, ML6 0, United Kingdom
GSK Investigational Site
Bristol , BS2 8, United Kingdom
GSK Investigational Site
Cardiff , CF14 , United Kingdom
University Hospital of Wales
Cardiff , CF14 , United Kingdom
GSK Investigational Site
London , W12 0, United Kingdom
Imperial College Healthcare NHS Trust
London , W12 O, United Kingdom
GSK Investigational Site
Oxford. , OX3 7, United Kingdom
Oxford University Hospitals NHS Trust
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

237

Study ID:

NCT03441113

Recruitment Status:

Active, not recruiting

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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