Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
225
Countries
5
Sites
14
Myeloproliferative Neoplasms
Key facts
- Sponsor
- Incyte Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Feb 2024 → ongoing
- Decision date (initial)
- 2024-01-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Myeloproliferative Neoplasms
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Incyte Corp.
- Sponsor organisation
- Incyte Corp.
- Address
- 1801 Augustine Cut Off
- City
- Wilmington
- Postcode
- 19803-4404
- Country
- United States
Scientific contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Locations
5 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 20 | 2 |
| France | Ongoing, recruiting | 30 | 4 |
| Germany | Ongoing, recruiting | 30 | 3 |
| Italy | Ongoing, recruiting | 20 | 3 |
| Spain | Ongoing, recruiting | 30 | 2 |
| Rest of world
United Kingdom, Japan, Australia
|
— | 95 | — |
Investigational sites
Lillebaelt Hospital
Department of Hematology, Beriderbakken 4, 7100, Vejle
Zealand University Hospital
Department of Hematology, Vestermarksvej 9, 1., Roskilde
Centre Hospitalier Universitaire De Nimes
Clinical Hematology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Hopital Saint Louis
Clinical Investigation Center (CIC), 1 Avenue Claude Vellefaux, 75010, Paris
Institut Bergonie
Hematology department, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Gustave Roussy
Department of Therapeutic Innovations and Early Trials, 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsklinikum Ulm AöR
Department of Internal Medicine III, Albert-Einstein-Allee 23, Eselsberg, Ulm
Martin-Luther-Universitaet Halle-Wittenberg
Department of Hematology and Internal Oncology, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaetsklinikum Aachen AöR
Department of Hematology, Pauwelsstrasse 30, 52074, Aachen
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Departmental of Hematology, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Complex Operational Unit (UOC) Hematology - Via G. Massarenti 9 40138 Bologna Italy, Via Pietro Albertoni 15, 40138, Bologna
Careggi University Hospital
Departmental Hospital Section (SOD) of Hematology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
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 |
|---|---|---|---|---|---|
| Denmark | 2024-04-03 | 2025-04-08 | |||
| France | 2024-07-04 | 2024-09-24 | |||
| Germany | 2024-02-07 | 2024-04-05 | |||
| Italy | 2024-03-08 | 2024-05-06 | |||
| Spain | 2024-02-08 | 2024-10-01 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-20 | Spain | Acceptable 2024-01-19
|
2024-01-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-19 | Spain | Acceptable 2024-05-08
|
2024-05-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-07 | Spain | Acceptable 2024-05-08
|
2024-06-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-11 | Spain | Acceptable 2025-01-27
|
2025-01-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-16 | Spain | Acceptable 2025-12-09
|
2025-12-10 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-20 | Spain | Acceptable 2025-12-09
|
2026-03-20 |