Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
335
Countries
10
Sites
39
Primary Myelofibrosis (PMF), Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
"To provide extended access to momelotinib and assess long-term safety in 4 cohorts of subjects who are currently receiving treatment with MMB and have not experienced progression of disease: - Cohort 1: Study GS-US-352-0101, subjects with PMF or post-PV/ET MF - Cohort 2: Study GS-US-352-1214, subjects with PMF or post…
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Jul 2018 → ongoing
- Decision date (initial)
- 2024-07-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- GlaxoSmithKline Research & Development Limited
External identifiers
- EU CT number
- 2023-508018-41-00
- EudraCT number
- 2017-004350-42
- ClinicalTrials.gov
- NCT03441113
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
"To provide extended access to momelotinib and assess long-term safety
in 4 cohorts of subjects who are currently receiving treatment with MMB
and have not experienced progression of disease:
- Cohort 1: Study GS-US-352-0101, subjects with PMF or post-PV/ET MF
- Cohort 2: Study GS-US-352-1214, subjects with PMF or post-PV/ET MF
- Cohort 3: Study GS-US-352-1154, subjects with PMF or post-PV/ET MF
- Cohort 4: Study SRA-MMB-301, subjects with PMF or post PV/ET MF"
Secondary objectives 1
- To assess overall survival (OS) and leukemia-free survival (LFS) in all subjects
Conditions and MedDRA coding
Primary Myelofibrosis (PMF), Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10028537 | Myelofibrosis | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- For subjects continuing MMB treatment: - Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
- For subjects continuing MMB treatment: - Able to comprehend and willing to sign the informed consent form
Exclusion criteria 1
- Known hypersensitivity to MMB, its metabolites, or formulation excipient
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Safety: Incidence, severity, seriousness, and causal relationship of AEs, as defined by CTCAE Version 4.03
Secondary endpoints 1
- Efficacy: overall survival (OS) and leukemia-free survival (LFS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Momelotinib Dihydrochloride Monohydrate
PRD11032047 · Product
- Active substance
- Momelotinib Dihydrochloride Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200.00 mg milligram(s)
- Max total dose
- 504000 mg milligram(s)
- Max treatment duration
- 84 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/11/886;887;888
Momelotinib Dihydrochloride Monohydrate
PRD11032121 · Product
- Active substance
- Momelotinib Dihydrochloride Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200.00 mg milligram(s)
- Max total dose
- 504000 mg milligram(s)
- Max treatment duration
- 84 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/11/886;887;888
Momelotinib Dihydrochloride Monohydrate
PRD11032087 · Product
- Active substance
- Momelotinib Dihydrochloride Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200.00 mg milligram(s)
- Max total dose
- 504000 mg milligram(s)
- Max treatment duration
- 84 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/11/886;887;888
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Eclinical Solutions LLC ORG-100044778
|
Mansfield, United States | Data management, E-data capture |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 2, Code 5, Code 8 |
| Tata Consultancy Services Limited ORG-100044792
|
Mumbai, India | Other, Code 8 |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Code 14 |
Locations
10 EU/EEA countries · 39 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 5 | 2 |
| Bulgaria | Ongoing, recruitment ended | 7 | 1 |
| Denmark | Ongoing, recruitment ended | 3 | 1 |
| France | Ongoing, recruitment ended | 28 | 3 |
| Germany | Ongoing, recruitment ended | 20 | 3 |
| Hungary | Ongoing, recruitment ended | 27 | 4 |
| Italy | Ongoing, recruitment ended | 22 | 10 |
| Poland | Ongoing, recruitment ended | 32 | 6 |
| Romania | Ongoing, recruitment ended | 8 | 3 |
| Spain | Ongoing, recruitment ended | 33 | 6 |
| Rest of world
Israel, Taiwan, Canada, Australia, United States, Singapore, Korea, Republic of, United Kingdom
|
— | 150 | — |
Investigational sites
Az St-Jan Brugge-Oostende A.V.
Department of Hematology, Ruddershove 10, 8000, Brugge
Het Ziekenhuisnetwerk Antwerpen
Department of Hematology, Kempenstraat 100, 2030, Antwerp
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Third Department of Clinical Hematology to Clinic of Clinical Hematology, Bulevard Kliment Ohridski 1a, 1797, Sofiya
Centre Hospitalier Universitaire De Lille
Service des Maladies du Sang, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Bordeaux
Service Hématologie Clinique et Thérapie Cellulaire, Avenue De Magellan, 33600, Pessac
Groupe D’Etude Des Lymphomes De L’Adulte
Service d'Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69495, Pierre Benite Cedex
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Aachen AöR
Medizinische Klinik IV, Hämatologie und Onkologie, Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Hämatologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department of Haematology, Tallian Gyula Utca 20-32, 7400, Kaposvar
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department of Internal Medicine, Szent Istvan Utca 68, 4400, Nyiregyhaza
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department of Haematology, Dozsa Gyorgy Ut 77, 2800, Tatabanya
University Of Debrecen
Department of Internal Medicine, Nagyerdei Korut 98, 4032, Debrecen
Centro Ricerche Cliniche Di Verona S.r.l.
Department of Medicine, Section of Hematology, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department of Clinical Medicine and Surgery, Via Sergio Pansini 5, 80131, Naples
Careggi University Hospital
Department of Haematology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
IRCCS Centro Di Riferimento Oncologico Della Basilicata
Department of Haematology, Via Padre Pio 1, 85028, Rionero In Vulture
Universita' Degli Studi Di Roma La Sapienza
Department of Cellular Biotechnologies and Hematology, Viale Del Policlinico 155, 00161, Rome
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department of Haematology, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliera S Gerardo Di Monza Laboratorio Per La Terapia Cellulare E Genica Stefano Verri
Department of Haematology, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department of Oncology, Corso Bramante 88, 10126, Turin
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department of Clinical and Biological Sciences, Via Ferdinando Magellano 1, 10128, Turin
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scienti
Institute of Hematology, Via Giuseppe Massarenti 9, 40138, Bologna
Wielospecjalistyczny Szpital Miejski Im. Jozefa Strusia Z Zakladem Opiekunczo Leczniczym. Samodzielny Publiczny Zaklad Opieki Zdrowotnej Z Siedziba W Poznaniu Przy Ul. Szwajcarskiej 3
Oddział Hematologii i Chorób Wewnętrznych, Ul. Szwajcarska 3, 61-285, Poznan
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddzial Hematologii Onkologicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Szpital Kliniczny nr 1 w Lublinie, Ul. Stanislawa Staszica 11, 20-081, Lublin
Szpital Wojewodzki W Opolu Sp. z o.o.
Oddzial Hematologii i Onkologii Hematologicznej, Ul. Katowicka 64, 45-061, Opole
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddzial Kliniczny Hematologii, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Spitalul Clinic Coltea
Spitalul Clinic Coltea, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Spitalul Clinic Municipal Filantropia Craiova
Spitalul Clinic Minicipal Filantropia Craiova, Strada Filantropiei No 1, 200143, Craiova
Onco Card S.R.L.
Spitalul de Oncologie MedLife Brasov, Strada Carierei 65 A, 500052, Brasov
Hospital Universitario Puerta De Hierro De Majadahonda
Department of Haematology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario Ramon Y Cajal
Department of Medicine and Medical Specialties, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Department of Haematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
CEIM Hospital Universitari Germans Trias I Pujol
Department of Haematology, Edificio General Carretera De Canyet S/N, 08916, Badalona
Complejo Hospitalario QuirónSalud
Department of Haematology, Avenida Gomez Laguna 159, 50012, Zaragoza
Clinica Universidad De Navarra
Department of Haematology, Avenue Pio XII 36, 31008, Pamplona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2019-01-10 | 2019-02-08 | 2022-04-25 | ||
| Bulgaria | 2018-07-27 | 2018-09-04 | 2021-11-24 | ||
| Denmark | 2018-11-27 | 2018-12-20 | 2022-06-09 | ||
| France | 2018-09-10 | 2018-10-27 | 2022-05-03 | ||
| Germany | 2019-03-29 | 2019-04-11 | 2022-09-14 | ||
| Hungary | 2018-07-27 | 2018-08-08 | 2022-09-07 | ||
| Italy | 2018-12-07 | 2022-07-11 | 2022-12-29 | ||
| Poland | 2018-11-02 | 2018-11-28 | 2022-04-14 | ||
| Romania | 2018-10-19 | 2018-11-27 | 2022-05-10 | ||
| Spain | 2018-07-31 | 2018-09-12 | 2021-10-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 67 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-508018-41-00_redacted | 7.0 |
| Recruitment arrangements (for publication) | K_BE_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_BG_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_DE_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_DK_Recruitment Arrangements_Placeholder document | 2 |
| Recruitment arrangements (for publication) | K_ES_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_FR_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_HU_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_IT_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_PL_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_RO_Recruitment Arrangement_Placeholder document | 1 |
| Subject information and informed consent form (for publication) | L_IT_CET approval_Placeholder document | 1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main ICF_Dutch_redacted | 14.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main ICF_French_redacted | 14.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy FU ICF_Dutch_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy FU ICF_French_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_Bulgarian_redacted | 14.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_redacted | 14.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Partner Pregnancy_Bulgarian_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Partner Pregnancy_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main_German | 14.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnancy_German_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Addendum_Danish_anonymized | 7.0A |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Main_Danish_redacted | 14.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Partner Pregnancy_Danish_anonymized | 5.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish_redacted | 14.1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnancy_Spanish_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 14.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Partner Pregnancy_French_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_Global_SIS-ICF_Main_redacted | 12.0 |
| Subject information and informed consent form (for publication) | L1_Global_SIS-ICF_Partner Pregnancy_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Main_Hungarian_redacted | 12.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Pregnancy_Hungarian_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_HU_Other subject material_Placeholder document | 1 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Pregnancy_Hungarian_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main_Hungarian_redacted | 14.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Data_Italian_redacted | 14.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Main_Italian_redacted | 14.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Pregnancy_Italian_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 14.1 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnant Partner_Polish_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_Redacted | 14.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_Romanian_Redacted | 14.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnancy_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnancy_Romanian_Redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_Bulgarian_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_Dutch_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_French_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_French_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_German_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_Hungarian_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_Italian_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_Polish_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_Romanian_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-508018-41-00_Spanish_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508018-41-00 _Italian_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508018-41-00_Bulgarian_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508018-41-00_Dutch_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508018-41-00_French_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508018-41-00_French_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508018-41-00_German_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508018-41-00_Hungarian_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508018-41-00_Polish_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508018-41-00_redacted | 6.0-FR |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508018-41-00_Romanian_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508018-41-00_Spanish_redacted | 7.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | Italy | Acceptable 2024-07-01
|
2024-07-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-05 | Acceptable | 2024-09-23 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-27 | Italy | Acceptable 2025-03-25
|
2025-03-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-31 | Acceptable | 2025-09-08 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-11 | Acceptable | 2025-12-11 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-15 | Italy | Acceptable 2026-03-20
|
2026-03-20 |