Extended Access of Momelotinib in Adults With Myelofibrosis

Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03441113
• Other study ID #: 219627
• Secondary ID: 2017-004350-42SR
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 3, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 237
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Polycythemia
• Polycythemia Vera
• Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
• Post-polycythemia Vera Myelofibrosis (Post-PV MF)
• Primary Myelofibrosis
• Primary Myelofibrosis (PMF)
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Drug:
• MMB
Tablet(s) administered orally once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Romania,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.