Clinical trial • Phase I • Oncology

INCA033989 for Myeloproliferative neoplasms | Myelofibrosis | Essential thrombocythemia

Phase I trial of INCA033989 for Myeloproliferative neoplasms | Myelofibrosis | Essential thrombocythemia. 95 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Myeloproliferative neoplasms | Myelofibrosis | Essential thrombocythemia
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
20-09-2023
First CTIS Authorization Date
19-01-2024

Trial design

Phase I trial across 14 sites in Spain, Denmark, Germany and others.

Target Sample Size
95

Recruitment

Planned Sample Size
95
Recruitment Window Months
47

Geography

Total Number Of Sites
14
Total Number Of Participants
130

Spain

Earliest CTIS Part Ii Submission Date
12-12-2023
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
729
Number Of Sites
2
Number Of Participants
30

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Elvira Mora
Principal Investigator Email
mora_elv@gva.es
Contact Person Name
Elvira Mora
Contact Person Email
mora_elv@gva.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Rosa Maria Ayala
Principal Investigator Email
rayaladiaz12@gmail.com
Contact Person Name
Rosa Maria Ayala
Contact Person Email
rayaladiaz12@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
15-12-2023
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
726
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Zealand University Hospital
Department Name
Department of Hematology
Principal Investigator Name
Mikkel Helleberg Dorff
Principal Investigator Email
mihd@regionsjaelland.dk
Contact Person Name
Mikkel Helleberg Dorff
Contact Person Email
mihd@regionsjaelland.dk
Site Name
Lillebaelt Hospital
Department Name
Department of Hematology
Principal Investigator Name
Louise Hur Hannig
Principal Investigator Email
louise.hur.hannig@rsyd.dk
Contact Person Name
Louise Hur Hannig
Contact Person Email
louise.hur.hannig@rsyd.dk

Germany

Earliest CTIS Part Ii Submission Date
10-01-2024
Latest Decision Or Authorization Date
11-12-2025
Processing Time Days
701
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Universitaetsklinikum Aachen AöR
Department Name
Department of Hematology
Principal Investigator Name
Steffen Koschmieder
Principal Investigator Email
skoschmieder@ukaachen.de
Contact Person Name
Steffen Koschmieder
Contact Person Email
skoschmieder@ukaachen.de
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Department of Hematology and Internal Oncology
Principal Investigator Name
Haifa Kathrin Al-Ali
Principal Investigator Email
haifa.al-ali@ul-halle.de
Contact Person Name
Haifa Kathrin Al-Ali
Contact Person Email
haifa.al-ali@ul-halle.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Department of Internal Medicine III
Principal Investigator Name
Frank Stegelmann
Principal Investigator Email
frank.stegelmann@uniklinik-ulm.de
Contact Person Name
Frank Stegelmann

France

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
11-12-2025
Processing Time Days
724
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Clinical Hematology
Principal Investigator Name
Stefan Wickenhauser
Principal Investigator Email
stefan.wickenhauser@chu-nimes.fr
Contact Person Name
Stefan Wickenhauser
Site Name
Hopital Saint Louis
Department Name
Clinical Investigation Center (CIC)
Principal Investigator Name
Jean-Jacques Kiladjian
Principal Investigator Email
jean-jacques.kiladjian@aphp.fr
Contact Person Name
Jean-Jacques Kiladjian
Contact Person Email
jean-jacques.kiladjian@aphp.fr
Site Name
Institut Bergonie
Department Name
Hematology department
Principal Investigator Name
François-Xavier Mahon
Principal Investigator Email
f.mahon@bordeaux.unicancer.fr
Contact Person Name
François-Xavier Mahon
Contact Person Email
f.mahon@bordeaux.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Department of Therapeutic Innovations and Early Trials
Principal Investigator Name
Vincent Ribrag
Principal Investigator Email
vincent.ribrag@gustaveroussy.fr
Contact Person Name
Vincent Ribrag

Italy

Earliest CTIS Part Ii Submission Date
08-01-2024
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
704
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Complex Operational Unit (UOC) Hematology - Via G. Massarenti 9 40138 Bologna Italy
Principal Investigator Name
Francesca Palandri
Principal Investigator Email
francesca.palandri@unibo.it
Contact Person Name
Francesca Palandri
Contact Person Email
francesca.palandri@unibo.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Departmental of Hematology
Principal Investigator Name
Francesco Passamonti
Principal Investigator Email
francesco.passamonti@policlinico.mi.it
Contact Person Name
Francesco Passamonti
Site Name
Careggi University Hospital
Department Name
Departmental Hospital Section (SOD) of Hematology
Principal Investigator Name
Alessandro Maria Vannucchi
Principal Investigator Email
amvannucchi@unifi.it
Contact Person Name
Alessandro Maria Vannucchi
Contact Person Email
amvannucchi@unifi.it

Sponsor

Primary sponsor

Full Name
Incyte Corp.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
INCA033989

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