Clinical trial NCT03441113: Extended Access of Momelotinib in Adults With Myelofibrosis
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Neoplasms
Post-polycythemia Vera Myelofibrosis (Post-PV MF)
Primary Myelofibrosis (PMF)
Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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:
Other outcomes:
Locations:
city: Orange
country: United States
facility: IC Irvine Health
state: California
city: Stanford
country: United States
facility: GSK Investigational Site
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Aurora
country: United States
facility: GSK Investigational Site
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Rolling Meadows
country: United States
facility: Northwest Oncology & Hematology - Rolling Meadows
state: Illinois
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Saint Agnes Hospital
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute (DFCI)
state: Massachusetts
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Department of Hematology
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine Siteman Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Hackensack
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Mayo Clinic Building - Phoenix
state: Wisconsin
city: Hyde Park
country: Australia
facility: Icon Cancer Care Wesley
state: Queensland
city: South Brisbane
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Frankston
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Perth
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen
state: Upper Austria
city: Wien
country: Austria
facility: Medizinische Universität Wien
state: Vienna
city: Linz
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
facility: GSK Investigational Site
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
state: West-Vlaanderen
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Stuivenberg
city: Brugge
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Pleven
country: Bulgaria
facility: UMHAT Dr. Georgi Stranski EAD
city: Ruse
country: Bulgaria
facility: GSK Investigational Site
city: Ruse
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Ruse
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: National Specialized Hospital for Active Treatment of Haematologic Diseases
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment St. Ivan Rilski
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Herlev
country: Denmark
facility: Gentofte Hospital
city: Koebenhavn
country: Denmark
facility: GSK Investigational Site
city: Ålborg
country: Denmark
facility: GSK Investigational Site
city: Paris
country: France
facility: Hopital Saint-Louis
state: ILE-De-FRANCE
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
state: Pays De La Loire
city: Le Mans Cedex
country: France
facility: GSK Investigational Site
city: Lille Cedex
country: France
facility: CHRU Huriez Lille
city: Marseille CEDEX 9
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Paris cedex 10
country: France
facility: GSK Investigational Site
city: Pessac cedex
country: France
facility: GSK Investigational Site
city: Pessac Cedex
country: France
facility: Hôpital Haut-Lévêque
city: Pierre Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Pierre-Bénite cedex
country: France
facility: GSK Investigational Site
city: Toulouse Cedex 9
country: France
facility: GSK Investigational Site
city: Toulouse Cedex 9
country: France
facility: Institut Universitaire du Cancer
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Aachen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Halle
country: Germany
facility: Universitätsklinikum Halle
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck
state: Schleswig-Holstein
city: Cologne
country: Germany
facility: University Hospital of Cologne
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universität Mainz
city: Győr
country: Hungary
facility: Petz Aladár Egyetemi Oktató Kórház - Győr
state: Gyor-Moson-Sopron
city: Tatabánya
country: Hungary
facility: Szent Borbála Kórház
state: Komárom-Esztergom
city: Budapest
country: Hungary
facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
state: Pest
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
state: Szabolcs-Szatmár-Bereg
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Győr
country: Hungary
facility: GSK Investigational Site
city: Kaposvár
country: Hungary
facility: GSK Investigational Site
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktató Kórház
city: Nyiregyhaza
country: Hungary
facility: GSK Investigational Site
city: Tatabánya
country: Hungary
facility: GSK Investigational Site
city: Afula
country: Israel
facility: GSK Investigational Site
city: Afula
country: Israel
facility: Emek Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center, Hematology Institute
city: Ashkelton
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Jerusalem
country: Israel
facility: GSK Investigational Site
city: Jerusalem
country: Israel
facility: Hadassh Medical Organization
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Rionero In Vulture (Pz)
country: Italy
facility: GSK Investigational Site
state: Basilicata
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Firenze
country: Italy
facility: Azienda Ospedaliero - Universitaria Careggi
state: Florence
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Monza (MB)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
state: Monza E Brianza
city: Pesaro
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord
state: Pesaro E Urbino
city: Torino
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Firenze
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Torino
country: Italy
facility: GSK Investigational Site
state: Trentino-Alto Adige
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
state: Turin
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
state: Turin
city: Verona
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Pesaro
country: Italy
facility: GSK Investigational Site
city: Potenza
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Basilicata
city: Roma
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: Umberto I - Policlinico di Roma
city: Verona
country: Italy
facility: Ospedale Policlinico Giambattista Rossi Borgo Roma
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Busan Gwang'yeogsi [Pusan-Kwangyokshi]
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Daegu Gwang'yeogsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
city: Maastricht
country: Netherlands
facility: GSK Investigational Site
city: Opole
country: Poland
facility: Szpital Wojewódzki w Opolu
state: Opolskie
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
state: Podkarpacki
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomoskie
city: Brzozow
country: Poland
facility: GSK Investigational Site
city: Chorzow
country: Poland
facility: GSK Investigational Site
city: Chorzów
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub
city: Małogoskie
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii
city: Opole
country: Poland
facility: GSK Investigational Site
city: Poznań
country: Poland
facility: GSK Investigational Site
city: Poznań
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Braşov
country: Romania
facility: Policlinica de Diagnostic Rapid SA
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Cluj-Napoca
country: Romania
facility: GSK Investigational Site
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuţă
city: Craiova
country: Romania
facility: GSK Investigational Site
city: Craiova
country: Romania
facility: Spitalul Clinic Municipal Filantropia Craiova
city: Iasi
country: Romania
facility: GSK Investigational Site
city: Iasi
country: Romania
facility: Institutul Regional De Oncologie IASI
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: Raffles Hospital
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: Institut Hospital del Mar d'Investigacions Mèdiques
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Majadahonda (Madrid)
country: Spain
facility: GSK Investigational Site
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Pamplona
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: Hospital de Día Quirónsalud Zaragoza
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol and Weston NHS Foundation Trust
state: England
city: Airdrie
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Airdrie
country: United Kingdom
facility: NHS Lanarkshire
state: Scotland
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Oxford.
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: