Extended Access of Momelotinib in Adults With Myelofibrosis
- Conditions
- NeoplasmsPost-polycythemia Vera Myelofibrosis (Post-PV MF)Primary Myelofibrosis (PMF)Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
- Interventions
- Drug: MMB
- Registration Number
- NCT03441113
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 237
- 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
- Known hypersensitivity to MMB, its metabolites, or formulation excipients
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3: Study GS-US-352-1154 MMB 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.. Cohort 2: Study GS-US-352-1214 MMB 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. Cohort 4: Study SRA-MMB-301 MMB 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. Cohort 1: Study GS-US-352-0101 MMB 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (114)
IC Irvine Health
🇺🇸Orange, California, United States
GSK Investigational Site
🇬🇧Oxford., United Kingdom
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Northwest Oncology & Hematology - Rolling Meadows
🇺🇸Rolling Meadows, Illinois, United States
Saint Agnes Hospital
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Icon Cancer Care Wesley
🇦🇺Hyde Park, Queensland, Australia
Flinders Medical Centre
🇦🇺Adelaide, South Australia, Australia
Universitätsklinikum Dresden
🇩🇪Dresden, Germany
Azienda Ospedaliera Ospedali Riuniti Marche Nord
🇮🇹Pesaro, Pesaro E Urbino, Italy
Inje University Haeundae Paik Hospital
🇰🇷Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi], Korea, Republic of
Severance Hospital
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Hospital de Día Quirónsalud Zaragoza
🇪🇸Zaragoza, Spain
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
🇩🇪Lübeck, Schleswig-Holstein, Germany
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Ordensklinikum Linz Elisabethinen
🇦🇹Linz, Upper Austria, Austria
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Medizinische Universität Wien
🇦🇹Wien, Vienna, Austria
Centre Hospitalier Universitaire de Liège Site Sart Tilman
🇧🇪Liège, Belgium
UMHAT Dr. Georgi Stranski EAD
🇧🇬Pleven, Bulgaria
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
🇭🇺Budapest, Pest, Hungary
Emek Medical Center
🇮🇱Afula, Israel
Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia
🇭🇺Budapest, Hungary
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Dana-Farber Cancer Institute (DFCI)
🇺🇸Boston, Massachusetts, United States
Barzilai Medical Center, Hematology Institute
🇮🇱Ashkelon, Israel
Spitalul Clinic Municipal Filantropia Craiova
🇷🇴Craiova, Romania
Raffles Hospital
🇸🇬Singapore, Singapore
Universitaire Ziekenhuis Leuven
🇧🇪Leuven, Belgium
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
🇧🇬Sofia, Bulgaria
Szpital Wojewódzki w Opolu
🇵🇱Opole, Opolskie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
🇵🇱Chorzów, Poland
Institutul Clinic Fundeni
🇷🇴Bucuresti, Romania
Chang Gung Memorial Hospital - Linkou Branch
🇨🇳Taoyuan, Taiwan
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Parkville, Victoria, Australia
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
🇧🇪Brugge, West-Vlaanderen, Belgium
Multiprofile Hospital for Active Treatment Ruse
🇧🇬Ruse, Bulgaria
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub
🇵🇱Lublin, Poland
Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii
🇵🇱Małogoskie, Poland
Institutul Oncologic Prof. Dr. Ion Chiricuţă
🇷🇴Cluj-Napoca, Romania
Institutul Regional De Oncologie IASI
🇷🇴Iasi, Romania
Ziekenhuis Netwerk Antwerpen Stuivenberg
🇧🇪Antwerp, Belgium
National Specialized Hospital for Active Treatment of Haematologic Diseases
🇧🇬Sofia, Bulgaria
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
🇭🇺Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Hadassh Medical Organization
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Spitalul Clinic Coltea
🇷🇴Bucuresti, Romania
Singapore General Hospital
🇸🇬Singapore, Singapore
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Maastricht University Medical Centre
🇳🇱Maastricht, Limburg, Netherlands
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Carmel Medical Center
🇮🇱Haifa, Israel
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
🇵🇱Brzozów, Podkarpacki, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdańsk, Pomoskie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego
🇵🇱Poznań, Poland
NHS Lanarkshire
🇬🇧Airdrie, Scotland, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
🇬🇧Bristol, England, United Kingdom
Mayo Clinic - Department of Hematology
🇺🇸Rochester, Minnesota, United States
Mayo Clinic Building - Phoenix
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Research Institute of the McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Sir Mortimer B. Davis Jewish General Hospital
🇨🇦Montréal, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Canada
Institut Paoli Calmettes
🇫🇷Marseille, France
Gentofte Hospital
🇩🇰Herlev, Denmark
Hopital Saint-Louis
🇫🇷Paris, ILE-De-FRANCE, France
CHRU Huriez Lille
🇫🇷Lille Cedex, France
Institut Universitaire du Cancer
🇫🇷Toulouse Cedex 9, France
Universitätsklinikum Aachen
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Centre Hospitalier Lyon Sud
🇫🇷Pierre Bénite Cedex, France
Centre Hospitalier Le Mans
🇫🇷Le Mans, Pays De La Loire, France
Hôpital Haut-Lévêque
🇫🇷Pessac Cedex, France
Universitätsklinikum Halle
🇩🇪Halle, Sachsen-Anhalt, Germany
University Hospital of Cologne
🇩🇪Cologne, Germany
Petz Aladár Egyetemi Oktató Kórház - Győr
🇭🇺Győr, Gyor-Moson-Sopron, Hungary
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Szent Borbála Kórház
🇭🇺Tatabánya, Komárom-Esztergom, Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek
🇭🇺Debrecen, Hungary
Somogy Megyei Kaposi Mor Oktató Kórház
🇭🇺Kaposvár, Hungary
Azienda Ospedaliero - Universitaria Careggi
🇮🇹Firenze, Florence, Italy
Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
🇮🇹Monza, Monza E Brianza, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
🇮🇹Torino, Turin, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
🇮🇹Torino, Turin, Italy
Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Umberto I - Policlinico di Roma
🇮🇹Roma, Italy
Catholic University of Korea Seoul Saint Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata
🇮🇹Potenza, Italy
Ospedale Policlinico Giambattista Rossi Borgo Roma
🇮🇹Verona, Italy
Kyungpook National University Hospital
🇰🇷Daegu, Daegu Gwang'yeogsi, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Policlinica de Diagnostic Rapid SA
🇷🇴Braşov, Romania
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Institut Hospital del Mar d'Investigacions Mèdiques
🇪🇸Barcelona, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Madrid, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Oxford University Hospitals NHS Trust
🇬🇧Oxford, United Kingdom
Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Montefiore Medical Center
🇺🇸Bronx, New York, United States