Last updated: 05/15/2024 17:50:07
Extended Access of Momelotinib in Adults with Myelofibrosis
GSK study ID
219627
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of Participants Who Had Access to, and Received the Intervention
Timeframe: Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
237
Primary completion date:
2026-31-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Post-polycythemia Vera Myelofibrosis (Post-PV MF)
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2018 to December 2026
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- Known hypersensitivity to MMB, its metabolites, or formulation excipients
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Inclusion and exclusion criteria
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
Exclusion criteria:
- Known hypersensitivity to MMB, its metabolites, or formulation excipients NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial location(s)
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21229-5299
Status
Recruiting
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom, ML6 0JS
Status
Recruiting
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Recruiting
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Recruiting
Location
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
Status
Recruiting
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32224
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Rionero in Vulture (Pz), Basilicata, Italy, 85028
Status
Recruiting
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Recruiting
Location
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Status
Recruiting
Location
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
Status
Recruiting
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
Status
Study Complete
Location
GSK Investigational Site
Stanford, California, United States, 94305-5821
Status
Study Complete
Location
Washington University School of Medicine Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
Status
Unmapped
Location
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States, 02215
Status
Unmapped
Location
Mayo Clinic Building - Phoenix
Milwaukee, Wisconsin, United States, 53226
Status
Recruiting
Location
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Status
Recruiting
Location
Mayo Clinic - Department of Hematology
Rochester, Minnesota, United States, 55905
Status
Recruiting
Location
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek
Debrecen, Hungary, 4032
Status
Recruiting
Location
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain, 28222
Status
Recruiting
Location
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Status
Recruiting
Location
Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia
Budapest, Hungary, 1083
Status
Recruiting
Location
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Status
Recruiting
Location
Oxford University Hospitals NHS Trust
Oxford, United Kingdom, OX3 7LJ
Status
Recruiting
Location
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 ONN
Status
Recruiting
Location
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego
Poznań, Poland, 60-631
Status
Recruiting
Location
Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii
Małogoskie, Poland, 31-501
Status
Recruiting
Location
Sir Mortimer B. Davis Jewish General Hospital
Montréal, Canada, H3T 1E2
Status
Recruiting
Location
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów, Podkarpacki, Poland, 36-200
Status
Recruiting
Location
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, Italy, 40138
Status
Recruiting
Location
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
Chorzów, Poland, 41-500
Status
Recruiting
Location
Barzilai Medical Center, Hematology Institute
Ashkelon, Israel, 78278
Status
Recruiting
Location
Centre Hospitalier Universitaire de Liège Site Sart Tilman
Liège, Belgium, 4000
Status
Unmapped
Location
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub
Lublin, Poland, 20-081
Status
Unmapped
Location
Institutul Oncologic Prof. Dr. Ion Chiricuţă
Cluj-Napoca, Romania, 400124
Status
Unmapped
Location
Maastricht University Medical Centre
Maastricht, LIMBURG, Netherlands, 6229 HX
Status
Unmapped
Location
Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona, Spain, 08003
Status
Recruiting
Location
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
NyÃregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
Status
Recruiting
Location
Severance Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 03722
Status
Recruiting
Location
Catholic University of Korea Seoul Saint Mary's Hospital
Seoul, South Korea, 06591
Status
Recruiting
Location
Kyungpook National University Hospital
Daegu, Daegu Gwang'yeogsi, South Korea, 41944
Status
Recruiting
Location
National Specialized Hospital for Active Treatment of Haematologic Diseases
Sofia, Bulgaria, 1431
Status
Recruiting
Location
Centre Hospitalier Le Mans
Le Mans, Pays de la Loire, France, 72037
Status
Recruiting
Location
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
Budapest, Pest, Hungary, 1097
Status
Recruiting
Location
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Brugge, West-Vlaanderen, Belgium, 8000
Status
Recruiting
Location
Azienda Ospedaliero - Universitaria Careggi
Firenze, Florence, Italy, 50134
Status
Recruiting
Location
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
Sofia, Bulgaria, 1431
Status
Recruiting
Location
Szent Borbála Kórház
Tatabánya, Komárom-Esztergom, Hungary, 2800
Status
Recruiting
Location
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, Pesaro e Urbino, Italy, 61121
Status
Recruiting
Location
Ospedale Policlinico Giambattista Rossi Borgo Roma
Verona, Italy, 37134
Status
Recruiting
Location
Universitätsklinikum Aachen
Aachen, Nordrhein-Westfalen, Germany, 52074
Status
Recruiting
Location
Spitalul Clinic Municipal Filantropia Craiova
Craiova, Romania, 200143
Status
Recruiting
Location
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Status
Recruiting
Location
Inje University Haeundae Paik Hospital
Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi], South Korea, 48108
Status
Recruiting
Location
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy, 20122
Status
Recruiting
Location
Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
Monza, Monza e Brianza, Italy, 20900
Status
Recruiting
Location
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Turin, Italy, 10128
Status
Recruiting
Location
IRCCS Centro di Riferimento Oncologico di Basilicata
Potenza, Italy, 85028
Status
Recruiting
Location
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, England, United Kingdom, BS2 8ED
Status
Recruiting
Location
Research Institute of the McGill University Health Centre
Montréal, Quebec, Canada, H3H 2R9
Status
Recruiting
Location
Ordensklinikum Linz Elisabethinen
Linz, Upper Austria, Austria, 4020
Status
Recruiting
Location
Northwest Oncology & Hematology - Rolling Meadows
Rolling Meadows, Illinois, United States, 60008
Status
Recruiting
Location
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Status
Recruiting
Location
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Status
Recruiting
Location
Petz Aladár Egyetemi Oktató Kórház - Győr
Győr, Gyor-Moson-Sopron, Hungary, 9023
Status
Recruiting
Location
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Turin, Italy, 10126
Status
Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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