Clinical trial • Phase IV • Oncology
MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE for Primary myelofibrosis | Post-polycythaemia vera myelofibrosis | Post-essential thrombocythemia myelofibrosis
Phase IV trial of MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE for Primary myelofibrosis | Post-polycythaemia vera myelofibrosis | Post-essential thrombocythem…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Primary myelofibrosis | Post-polycythaemia vera myelofibrosis | Post-essential thrombocythemia myelofibrosis
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 24-05-2024
- First CTIS Authorization Date
- 02-07-2024
Trial design
open-label Phase IV trial across 39 sites in Italy, Germany, Romania and others.
- Open Label
- Yes
- Target Sample Size
- 150
Eligibility
Recruits 150 The trial record flags vulnerable population selection. Inclusion requires that subjects be "Able to comprehend and willing to sign the informed consent form". Subject information and informed consent forms (including pregnancy-related documents) are provided per country; no explicit assent process for minors is described in the available materials..
- Vulnerable Population
- The trial record flags vulnerable population selection. Inclusion requires that subjects be "Able to comprehend and willing to sign the informed consent form". Subject information and informed consent forms (including pregnancy-related documents) are provided per country; no explicit assent process for minors is described in the available materials.
Inclusion criteria
- {"criterion_text":"- 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"}
- {"criterion_text":"- For subjects continuing MMB treatment: - Able to comprehend and willing to sign the informed consent form"}
Exclusion criteria
- {"criterion_text":"- Known hypersensitivity to MMB, its metabolites, or formulation excipient"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Safety: Incidence, severity, seriousness, and causal relationship of AEs, as defined by CTCAE Version 4.03","definition_or_measurement_approach":"Adverse events assessed by incidence, severity, seriousness and causal relationship according to CTCAE v4.03"}
Secondary endpoints
- {"endpoint_text":"- Efficacy: overall survival (OS) and leukemia-free survival (LFS)","definition_or_measurement_approach":"Overall survival (OS) and leukemia-free survival (LFS) measured as time-to-event endpoints (no further definition provided in the record)"}
Recruitment
- Planned Sample Size
- 150
- Recruitment Window Months
- 105
- Consent Approach
- Participants must be "Able to comprehend and willing to sign the informed consent form" (inclusion criterion). Country-specific subject information and informed consent forms (SIS-ICF) and pregnancy/partner forms are provided; ICF documents are available in multiple languages (examples in the record include Italian, German, Romanian, Danish, Bulgarian, Spanish, Polish, Hungarian, French, Dutch and a Global/English version).
Geography
- Total Number Of Sites
- 39
- Total Number Of Participants
- 185
Italy
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 647
- Number Of Sites
- 10
- Number Of Participants
- 22
Sites
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Department of Clinical Medicine and Surgery
- Principal Investigator Name
- Fabrizio Pane
- Principal Investigator Email
- fabrizio.pane@unina.it
- Contact Person Name
- Fabrizio Pane
- Contact Person Email
- fabrizio.pane@unina.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Department of Haematology
- Principal Investigator Name
- Alessandra Iurlo
- Principal Investigator Email
- alessandra.iurlo@policlinico.mi.it
- Contact Person Name
- Alessandra Iurlo
- Contact Person Email
- alessandra.iurlo@policlinico.mi.it
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- Department of Clinical and Biological Sciences
- Principal Investigator Name
- Carmen Fava
- Principal Investigator Email
- carmen.fava@unito.it
- Contact Person Name
- Carmen Fava
- Contact Person Email
- carmen.fava@unito.it
- Site Name
- Careggi University Hospital
- Department Name
- Department of Haematology
- Principal Investigator Name
- Alessandro Maria Vannucchi
- Principal Investigator Email
- a.vannucchi@unifi.it
- Contact Person Name
- Alessandro Maria Vannucchi
- Contact Person Email
- a.vannucchi@unifi.it
- Site Name
- IRCCS Centro Di Riferimento Oncologico Della Basilicata
- Department Name
- Department of Haematology
- Principal Investigator Name
- Giuseppe Pietrantuono
- Principal Investigator Email
- giuseppe.pietrantuono@crob.it
- Contact Person Name
- Giuseppe Pietrantuono
- Contact Person Email
- giuseppe.pietrantuono@crob.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Department of Oncology
- Principal Investigator Name
- Eloise Beggiato
- Principal Investigator Email
- ebeggiato@cittadellasalute.to.it
- Contact Person Name
- Eloise Beggiato
- Contact Person Email
- ebeggiato@cittadellasalute.to.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Department of Medicine, Section of Hematology
- Principal Investigator Name
- Massimiliano Bonifacio
- Principal Investigator Email
- massimiliano.bonifacio@univr.it
- Contact Person Name
- Massimiliano Bonifacio
- Contact Person Email
- massimiliano.bonifacio@univr.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scienti
- Department Name
- Institute of Hematology
- Principal Investigator Name
- Piere Luigi Zinzani
- Principal Investigator Email
- pierluigi.zinzani@unibo.it
- Contact Person Name
- Piere Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
- Site Name
- Azienda Ospedaliera S Gerardo Di Monza Laboratorio Per La Terapia Cellulare E Genica Stefano Verri
- Department Name
- Department of Haematology
- Principal Investigator Name
- Elena Maria Elli
- Principal Investigator Email
- elenamaria.elli@irccs-sangerardo.it
- Contact Person Name
- Elena Maria Elli
- Contact Person Email
- elenamaria.elli@irccs-sangerardo.it
- Site Name
- Universita' Degli Studi Di Roma La Sapienza
- Department Name
- Department of Cellular Biotechnologies and Hematology
- Principal Investigator Name
- Massimo Breccia
- Principal Investigator Email
- massimo.breccia@uniroma1.it
- Contact Person Name
- Massimo Breccia
- Contact Person Email
- massimo.breccia@uniroma1.it
Germany
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 651
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Hämatologie und Onkologie
- Principal Investigator Name
- Nikolas von Bubnoff
- Principal Investigator Email
- nikolas.vonbubnoff@uksh.de
- Contact Person Name
- Nikolas von Bubnoff
- Contact Person Email
- nikolas.vonbubnoff@uksh.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Medizinische Klinik IV, Hämatologie und Onkologie
- Principal Investigator Name
- Steffen Koschmieder
- Principal Investigator Email
- skoschmieder@ukaachen.de
- Contact Person Name
- Steffen Koschmieder
- Contact Person Email
- skoschmieder@ukaachen.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Jan Moritz Middeke
- Principal Investigator Email
- moritz.middeke@uniklinikum-dresden.de
- Contact Person Name
- Jan Moritz Middeke
- Contact Person Email
- moritz.middeke@uniklinikum-dresden.de
Romania
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 673
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Spitalul Clinic Municipal Filantropia Craiova
- Department Name
- Spitalul Clinic Minicipal Filantropia Craiova
- Principal Investigator Name
- Luminita Ocroteala
- Principal Investigator Email
- diaconu_luminita@yahoo.com
- Contact Person Name
- Luminita Ocroteala
- Contact Person Email
- diaconu_luminita@yahoo.com
- Site Name
- Onco Card S.R.L.
- Department Name
- Spitalul de Oncologie MedLife Brasov
- Principal Investigator Name
- Mihaela Cornelia Lazaroiu
- Principal Investigator Email
- ellalaz@yahoo.com
- Contact Person Name
- Mihaela Cornelia Lazaroiu
- Contact Person Email
- ellalaz@yahoo.com
- Site Name
- Spitalul Clinic Coltea
- Department Name
- Spitalul Clinic Coltea
- Principal Investigator Name
- Andrei Colita
- Principal Investigator Email
- andreicolita@yahoo.com
- Contact Person Name
- Andrei Colita
- Contact Person Email
- andreicolita@yahoo.com
Denmark
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 647
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Marianne Severinsen
- Principal Investigator Email
- m.severinsen@rn.dk
- Contact Person Name
- Marianne Severinsen
- Contact Person Email
- m.severinsen@rn.dk
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 665
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Specialized Hospital For Active Treatment Of Hematological Diseases EAD
- Department Name
- Third Department of Clinical Hematology to Clinic of Clinical Hematology
- Principal Investigator Name
- Tihomir Zhivkov
- Principal Investigator Email
- tihomir.zhivkov@abv.bg
- Contact Person Name
- Tihomir Zhivkov
- Contact Person Email
- tihomir.zhivkov@abv.bg
Spain
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 654
- Number Of Sites
- 6
- Number Of Participants
- 33
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Department of Haematology
- Principal Investigator Name
- Laura Fox
- Principal Investigator Email
- laura.fox@vallhebron.cat
- Contact Person Name
- Laura Fox
- Contact Person Email
- laura.fox@vallhebron.cat
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Department of Haematology
- Principal Investigator Name
- Ramon Lecumberri Villamediana
- Principal Investigator Email
- rlecumber@unav.es
- Contact Person Name
- Ramon Lecumberri Villamediana
- Contact Person Email
- rlecumber@unav.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Department of Haematology
- Principal Investigator Name
- Lucia Peres Lamas
- Principal Investigator Email
- lplamas@salud.madrid.org
- Contact Person Name
- Lucia Peres Lamas
- Contact Person Email
- lplamas@salud.madrid.org
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Department of Medicine and Medical Specialties
- Principal Investigator Name
- Jose Valentin García-Gutiérrez
- Principal Investigator Email
- jvalentingg@gmail.com
- Contact Person Name
- Jose Valentin García-Gutiérrez
- Contact Person Email
- jvalentingg@gmail.com
- Site Name
- Complejo Hospitalario QuirónSalud
- Department Name
- Department of Haematology
- Principal Investigator Name
- Maria Pilar Giraldo Castellano
- Principal Investigator Email
- giraldocastellano@gmail.com
- Contact Person Name
- Maria Pilar Giraldo Castellano
- Contact Person Email
- giraldocastellano@gmail.com
- Site Name
- CEIM Hospital Universitari Germans Trias I Pujol
- Department Name
- Department of Haematology
- Principal Investigator Name
- Blanca Xicoy
- Principal Investigator Email
- bxicoy@iconcologia.net
- Contact Person Name
- Blanca Xicoy
- Contact Person Email
- bxicoy@iconcologia.net
Belgium
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 651
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- Department of Hematology
- Principal Investigator Name
- Jan Van Droogenbroeck
- Principal Investigator Email
- jan.vandroogenbroeck@azsintjan.be
- Contact Person Name
- Jan Van Droogenbroeck
- Contact Person Email
- jan.vandroogenbroeck@azsintjan.be
- Site Name
- Het Ziekenhuisnetwerk Antwerpen
- Department Name
- Department of Hematology
- Principal Investigator Name
- Nikki Granacher
- Principal Investigator Email
- nikki.granacher@zna.be
- Contact Person Name
- Nikki Granacher
- Contact Person Email
- nikki.granacher@zna.be
Poland
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 650
- Number Of Sites
- 6
- Number Of Participants
- 32
Sites
- Site Name
- Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
- Department Name
- Oddzial Hematologii Onkologicznej
- Principal Investigator Name
- Jacek Krzanowski
- Principal Investigator Email
- jacek.krzanowski@gmail.com
- Contact Person Name
- Jacek Krzanowski
- Contact Person Email
- jacek.krzanowski@gmail.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddzial Kliniczny Hematologii
- Principal Investigator Name
- Tomasz Sacha
- Principal Investigator Email
- sachatom@gmail.com
- Contact Person Name
- Tomasz Sacha
- Contact Person Email
- sachatom@gmail.com
- Site Name
- Wielospecjalistyczny Szpital Miejski Im. Jozefa Strusia Z Zakladem Opiekunczo Leczniczym. Samodzielny Publiczny Zaklad Opieki Zdrowotnej Z Siedziba W Poznaniu Przy Ul. Szwajcarskiej 3
- Department Name
- Oddział Hematologii i Chorób Wewnętrznych
- Principal Investigator Name
- Mariola Bober
- Principal Investigator Email
- mariolabober@o2.pl
- Contact Person Name
- Mariola Bober
- Contact Person Email
- mariolabober@o2.pl
- Site Name
- Szpital Wojewodzki W Opolu Sp. z o.o.
- Department Name
- Oddzial Hematologii i Onkologicznej Hematologicznej
- Principal Investigator Name
- Dariusz Woszczyk
- Principal Investigator Email
- dariusz.s.woszczyk@gmail.com
- Contact Person Name
- Dariusz Woszczyk
- Contact Person Email
- dariusz.s.woszczyk@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Szpital Kliniczny nr 1 w Lublinie
- Principal Investigator Name
- Marek Hus
- Principal Investigator Email
- markhus@go2.pl
- Contact Person Name
- Marek Hus
- Contact Person Email
- markhus@go2.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Principal Investigator Name
- Witold Prejzner
- Principal Investigator Email
- wpre@gumed.edu.pl
- Contact Person Name
- Witold Prejzner
- Contact Person Email
- wpre@gumed.edu.pl
Hungary
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 652
- Number Of Sites
- 4
- Number Of Participants
- 27
Sites
- Site Name
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
- Department Name
- Department of Haematology
- Principal Investigator Name
- Miklos Egyed
- Principal Investigator Email
- dregyedmiklos@yahoo.com
- Contact Person Name
- Miklos Egyed
- Contact Person Email
- dregyedmiklos@yahoo.com
- Site Name
- University Of Debrecen
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Arpad Illes
- Principal Investigator Email
- illesarpaddr@gmail.com
- Contact Person Name
- Arpad Illes
- Contact Person Email
- illesarpaddr@gmail.com
- Site Name
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
- Department Name
- Department of Haematology
- Principal Investigator Name
- Peter Dombi
- Principal Investigator Email
- dombi.j@tatabanyakorhaz.hu
- Contact Person Name
- Peter Dombi
- Contact Person Email
- dombi.j@tatabanyakorhaz.hu
- Site Name
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Laszlo Rejto
- Principal Investigator Email
- lrejto@med.unideb.hu
- Contact Person Name
- Laszlo Rejto
- Contact Person Email
- lrejto@med.unideb.hu
France
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 652
- Number Of Sites
- 3
- Number Of Participants
- 28
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service des Maladies du Sang
- Principal Investigator Name
- Mathieu Wemeau
- Principal Investigator Email
- mathieu.wemeau@ch-roubaix.fr
- Contact Person Name
- Mathieu Wemeau
- Contact Person Email
- mathieu.wemeau@ch-roubaix.fr
- Site Name
- Groupe D’Etude Des Lymphomes De L’Adulte
- Department Name
- Service d'Hématologie Clinique
- Principal Investigator Name
- Fiorenza Barraco
- Principal Investigator Email
- fiorenza.Barraco@chu-lyon.fr
- Contact Person Name
- Fiorenza Barraco
- Contact Person Email
- fiorenza.Barraco@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service Hématologie Clinique et Thérapie Cellulaire
- Principal Investigator Name
- Clémence Mediavilla
- Principal Investigator Email
- clemence.mediavilla@chu-bordeaux.fr
- Contact Person Name
- Clémence Mediavilla
- Contact Person Email
- clemence.mediavilla@chu-bordeaux.fr
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Eclinical Solutions LLC
- Responsibilities
- Codes: 6|7
- Name
- Icon Clinical Research Limited
- Responsibilities
- Codes: 1|12|2|5|8
- Name
- Tata Consultancy Services Limited
- Responsibilities
- Codes/Notes: 15 (Medical Review and case processing)|8
- Name
- Signant Health LLC
- Responsibilities
- Codes: 14
Third parties
- {"country":"United States","full_name":"Eclinical Solutions LLC","duties_or_roles":"Codes: 6|7","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Codes: 1|12|2|5|8","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Tata Consultancy Services Limited","duties_or_roles":"Codes/Notes: 15 (Medical Review and case processing)|8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"Codes: 14","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- GSK3070785 (TABLET)
- Active Substance
- MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised (MIA number: IMP12407/00001)
- Orphan Designation
- Yes
- Maximum Dose
- 200 mg (max daily dose amount)
- Investigational Product Name
- GSK3070785 (TABLET)
- Active Substance
- MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised (MIA number: IMP12407/00001)
- Orphan Designation
- Yes
- Maximum Dose
- 200 mg (max daily dose amount)
- Investigational Product Name
- GSK3070785 (TABLET)
- Active Substance
- MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised (MIA number: IMP12407/00001)
- Orphan Designation
- Yes
- Maximum Dose
- 200 mg (max daily dose amount)
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