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Extended Access of Momelotinib in Adults With Myelofibrosis

Primary Purpose

Neoplasms, Post-polycythemia Vera Myelofibrosis (Post-PV MF), Primary Myelofibrosis (PMF)

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MMB
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IC Irvine Health
  • GSK Investigational Site
  • Stanford Hospital and Clinics
  • GSK Investigational Site
  • University of Colorado Cancer Center
  • GSK Investigational Site
  • Mayo Clinic Florida
  • GSK Investigational Site
  • Moffitt Cancer Center
  • GSK Investigational Site
  • Winship Cancer Institute, Emory University
  • Northwest Oncology & Hematology - Rolling Meadows
  • GSK Investigational Site
  • Saint Agnes Hospital
  • Dana-Farber Cancer Institute (DFCI)
  • GSK Investigational Site
  • GSK Investigational Site
  • Mayo Clinic - Department of Hematology
  • Washington University School of Medicine Siteman Cancer Center
  • GSK Investigational Site
  • GSK Investigational Site
  • Hackensack University Medical Center
  • GSK Investigational Site
  • Montefiore Medical Center
  • Cleveland Clinic Foundation
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • Mayo Clinic Building - Phoenix
  • Icon Cancer Care Wesley
  • GSK Investigational Site
  • Flinders Medical Centre
  • GSK Investigational Site
  • GSK Investigational Site
  • Frankston Hospital
  • GSK Investigational Site
  • The Alfred Hospital
  • GSK Investigational Site
  • Peter MacCallum Cancer Centre
  • GSK Investigational Site
  • Royal Perth Hospital
  • Ordensklinikum Linz Elisabethinen
  • Medizinische Universität Wien
  • GSK Investigational Site
  • GSK Investigational Site
  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
  • GSK Investigational Site
  • Ziekenhuis Netwerk Antwerpen Stuivenberg
  • GSK Investigational Site
  • GSK Investigational Site
  • Universitaire Ziekenhuis Leuven
  • Centre Hospitalier Universitaire de Liège Site Sart Tilman
  • GSK Investigational Site
  • GSK Investigational Site
  • UMHAT Dr. Georgi Stranski EAD
  • GSK Investigational Site
  • Multiprofile Hospital for Active Treatment Ruse
  • GSK Investigational Site
  • National Specialized Hospital for Active Treatment of Haematologic Diseases
  • University Multiprofile Hospital for Active Treatment St. Ivan Rilski
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • Research Institute of the McGill University Health Centre
  • Sir Mortimer B. Davis Jewish General Hospital
  • Princess Margaret Cancer Centre
  • Aalborg University Hospital
  • Gentofte Hospital
  • GSK Investigational Site
  • GSK Investigational Site
  • Hopital Saint-Louis
  • Centre Hospitalier Le Mans
  • GSK Investigational Site
  • CHRU Huriez Lille
  • GSK Investigational Site
  • Institut Paoli Calmettes
  • GSK Investigational Site
  • GSK Investigational Site
  • Hôpital Haut-Lévêque
  • Centre Hospitalier Lyon Sud
  • GSK Investigational Site
  • GSK Investigational Site
  • Institut Universitaire du Cancer
  • GSK Investigational Site
  • GSK Investigational Site
  • Universitätsklinikum Aachen
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • Universitätsklinikum Halle
  • GSK Investigational Site
  • GSK Investigational Site
  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck
  • University Hospital of Cologne
  • Universitätsklinikum Dresden
  • Universitätsklinikum Leipzig
  • Johannes Gutenberg-Universität Mainz
  • Petz Aladár Egyetemi Oktató Kórház - Győr
  • Szent Borbála Kórház
  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
  • Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
  • GSK Investigational Site
  • Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia
  • GSK Investigational Site
  • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • Somogy Megyei Kaposi Mor Oktató Kórház
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • Emek Medical Center
  • Barzilai Medical Center, Hematology Institute
  • GSK Investigational Site
  • Carmel Medical Center
  • GSK Investigational Site
  • GSK Investigational Site
  • Hadassh Medical Organization
  • Meir Medical Center
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • Azienda Ospedaliero - Universitaria Careggi
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
  • Azienda Ospedaliera Ospedali Riuniti Marche Nord
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
  • Azienda Ospedaliera Ordine Mauriziano di Torino
  • GSK Investigational Site
  • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
  • Azienda Ospedaliera Universitaria San Martino
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliera Universitaria Federico II
  • GSK Investigational Site
  • IRCCS Centro di Riferimento Oncologico di Basilicata
  • GSK Investigational Site
  • Umberto I - Policlinico di Roma
  • Ospedale Policlinico Giambattista Rossi Borgo Roma
  • Inje University Haeundae Paik Hospital
  • Kyungpook National University Hospital
  • Severance Hospital
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • Samsung Medical Center
  • Catholic University of Korea Seoul Saint Mary's Hospital
  • GSK Investigational Site
  • GSK Investigational Site
  • Seoul National University Hospital
  • Maastricht University Medical Centre
  • GSK Investigational Site
  • Szpital Wojewódzki w Opolu
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
  • Uniwersyteckie Centrum Kliniczne
  • GSK Investigational Site
  • GSK Investigational Site
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub
  • Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii
  • GSK Investigational Site
  • GSK Investigational Site
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego
  • GSK Investigational Site
  • Policlinica de Diagnostic Rapid SA
  • GSK Investigational Site
  • GSK Investigational Site
  • Spitalul Clinic Coltea
  • Institutul Clinic Fundeni
  • GSK Investigational Site
  • Institutul Oncologic Prof. Dr. Ion Chiricuţă
  • GSK Investigational Site
  • Spitalul Clinic Municipal Filantropia Craiova
  • GSK Investigational Site
  • Institutul Regional De Oncologie IASI
  • GSK Investigational Site
  • Singapore General Hospital
  • GSK Investigational Site
  • Raffles Hospital
  • Hospital Germans Trias i Pujol
  • GSK Investigational Site
  • Institut Hospital del Mar d'Investigacions Mèdiques
  • GSK Investigational Site
  • GSK Investigational Site
  • Hospital Universitari Vall d'Hebron
  • GSK Investigational Site
  • Hospital Universitario Ramón y Cajal
  • GSK Investigational Site
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Puerta de Hierro Majadahonda
  • GSK Investigational Site
  • Clínica Universidad de Navarra
  • GSK Investigational Site
  • GSK Investigational Site
  • Hospital de Día Quirónsalud Zaragoza
  • GSK Investigational Site
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • GSK Investigational Site
  • Kaohsiung Chang Gung Memorial Hospital
  • GSK Investigational Site
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital - Linkou Branch
  • GSK Investigational Site
  • University Hospitals Bristol and Weston NHS Foundation Trust
  • GSK Investigational Site
  • NHS Lanarkshire
  • GSK Investigational Site
  • GSK Investigational Site
  • University Hospital of Wales
  • GSK Investigational Site
  • Imperial College Healthcare NHS Trust
  • GSK Investigational Site
  • Oxford University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Cohort 1: Study GS-US-352-0101

Cohort 2: Study GS-US-352-1214

Cohort 3: Study GS-US-352-1154

Cohort 4: Study SRA-MMB-301

Arm Description

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.

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.

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..

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.

Outcomes

Primary Outcome Measures

Number of Participants Who Had Access to, and Received the Intervention

Secondary Outcome Measures

Full Information

First Posted
February 15, 2018
Last Updated
June 16, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT03441113
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Post-polycythemia Vera Myelofibrosis (Post-PV MF), Primary Myelofibrosis (PMF), Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Study GS-US-352-0101
Arm Type
Other
Arm Description
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.
Arm Title
Cohort 2: Study GS-US-352-1214
Arm Type
Other
Arm Description
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.
Arm Title
Cohort 3: Study GS-US-352-1154
Arm Type
Other
Arm Description
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..
Arm Title
Cohort 4: Study SRA-MMB-301
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MMB
Other Intervention Name(s)
GS-0387, CYT387
Intervention Description
Tablet(s) administered orally once daily
Primary Outcome Measure Information:
Title
Number of Participants Who Had Access to, and Received the Intervention
Time Frame
Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
IC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5821
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
GSK Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwest Oncology & Hematology - Rolling Meadows
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229-5299
Country
United States
Facility Name
Saint Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Dana-Farber Cancer Institute (DFCI)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mayo Clinic - Department of Hematology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
GSK Investigational Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
GSK Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Mayo Clinic Building - Phoenix
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Icon Cancer Care Wesley
City
Hyde Park
State/Province
Queensland
ZIP/Postal Code
4812
Country
Australia
Facility Name
GSK Investigational Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
GSK Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
GSK Investigational Site
City
Frankston
State/Province
Victoria
ZIP/Postal Code
31 99
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
GSK Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
GSK Investigational Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Ordensklinikum Linz Elisabethinen
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
State/Province
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
GSK Investigational Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
GSK Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
GSK Investigational Site
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Ziekenhuis Netwerk Antwerpen Stuivenberg
City
Antwerp
ZIP/Postal Code
2060
Country
Belgium
Facility Name
GSK Investigational Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Universitaire Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège Site Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT Dr. Georgi Stranski EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Ruse
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
01431
Country
Bulgaria
Facility Name
National Specialized Hospital for Active Treatment of Haematologic Diseases
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 2R9
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Research Institute of the McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3H 2R9
Country
Canada
Facility Name
Sir Mortimer B. Davis Jewish General Hospital
City
Montréal
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
GSK Investigational Site
City
Koebenhavn
ZIP/Postal Code
2100
Country
Denmark
Facility Name
GSK Investigational Site
City
Ålborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Hopital Saint-Louis
City
Paris
State/Province
ILE-De-FRANCE
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Hospitalier Le Mans
City
Le Mans
State/Province
Pays De La Loire
ZIP/Postal Code
72037
Country
France
Facility Name
GSK Investigational Site
City
Le Mans Cedex
ZIP/Postal Code
72037
Country
France
Facility Name
CHRU Huriez Lille
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
GSK Investigational Site
City
Marseille CEDEX 9
ZIP/Postal Code
13273
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
GSK Investigational Site
City
Paris cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
GSK Investigational Site
City
Pessac cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Haut-Lévêque
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
GSK Investigational Site
City
Pierre-Bénite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
GSK Investigational Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Universitaire du Cancer
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
GSK Investigational Site
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
GSK Investigational Site
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitätsklinikum Aachen
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Halle
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
University Hospital of Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Petz Aladár Egyetemi Oktató Kórház - Győr
City
Győr
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Szent Borbála Kórház
City
Tatabánya
State/Province
Komárom-Esztergom
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
City
Budapest
State/Province
Pest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
City
Nyíregyháza
State/Province
Szabolcs-Szatmár-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
GSK Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
GSK Investigational Site
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
GSK Investigational Site
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktató Kórház
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
GSK Investigational Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
GSK Investigational Site
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
GSK Investigational Site
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Emek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Barzilai Medical Center, Hematology Institute
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
GSK Investigational Site
City
Ashkelton
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
GSK Investigational Site
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
GSK Investigational Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Hadassh Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
GSK Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
GSK Investigational Site
City
Rionero In Vulture (Pz)
State/Province
Basilicata
ZIP/Postal Code
85028
Country
Italy
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Careggi
City
Firenze
State/Province
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
GSK Investigational Site
City
Monza (MB)
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
City
Pesaro
State/Province
Pesaro E Urbino
ZIP/Postal Code
61121
Country
Italy
Facility Name
GSK Investigational Site
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
GSK Investigational Site
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
GSK Investigational Site
City
Torino
State/Province
Trentino-Alto Adige
ZIP/Postal Code
10128
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
City
Torino
State/Province
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliera Ordine Mauriziano di Torino
City
Torino
State/Province
Turin
ZIP/Postal Code
10128
Country
Italy
Facility Name
GSK Investigational Site
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Pesaro
ZIP/Postal Code
61122
Country
Italy
Facility Name
IRCCS Centro di Riferimento Oncologico di Basilicata
City
Potenza
ZIP/Postal Code
85028
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Umberto I - Policlinico di Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale Policlinico Giambattista Rossi Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
State/Province
Busan Gwang'yeogsi [Pusan-Kwangyokshi]
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Daegu Gwang'yeogsi
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Catholic University of Korea Seoul Saint Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Maastricht
ZIP/Postal Code
6229 ER
Country
Netherlands
Facility Name
Szpital Wojewódzki w Opolu
City
Opole
State/Province
Opolskie
ZIP/Postal Code
45-064
Country
Poland
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
City
Brzozów
State/Province
Podkarpacki
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
State/Province
Pomoskie
ZIP/Postal Code
80-952
Country
Poland
Facility Name
GSK Investigational Site
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
GSK Investigational Site
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
GSK Investigational Site
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii
City
Małogoskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
GSK Investigational Site
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Facility Name
GSK Investigational Site
City
Poznań
ZIP/Postal Code
60-631
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego
City
Poznań
ZIP/Postal Code
60-631
Country
Poland
Facility Name
GSK Investigational Site
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Facility Name
Policlinica de Diagnostic Rapid SA
City
Braşov
ZIP/Postal Code
500152
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
Spitalul Clinic Coltea
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
22328
Country
Romania
Facility Name
GSK Investigational Site
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
Facility Name
Institutul Oncologic Prof. Dr. Ion Chiricuţă
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
Facility Name
GSK Investigational Site
City
Craiova
ZIP/Postal Code
200143
Country
Romania
Facility Name
Spitalul Clinic Municipal Filantropia Craiova
City
Craiova
ZIP/Postal Code
200143
Country
Romania
Facility Name
GSK Investigational Site
City
Iasi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Institutul Regional De Oncologie IASI
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
Facility Name
Raffles Hospital
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Institut Hospital del Mar d'Investigacions Mèdiques
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
GSK Investigational Site
City
Majadahonda (Madrid)
ZIP/Postal Code
28222
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
GSK Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
GSK Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital de Día Quirónsalud Zaragoza
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
Facility Name
GSK Investigational Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
GSK Investigational Site
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
88301
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
University Hospitals Bristol and Weston NHS Foundation Trust
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Airdrie
State/Province
Lanarkshire
ZIP/Postal Code
ML6 0JS
Country
United Kingdom
Facility Name
NHS Lanarkshire
City
Airdrie
State/Province
Scotland
ZIP/Postal Code
ML6 0JS
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 ONN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Oxford.
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Extended Access of Momelotinib in Adults With Myelofibrosis

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