Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
216
Countries
3
Sites
11
Treatment of participants with MF, MDS, ET, or MDS/MPN
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
- 11 May 2021 → ongoing
- Decision date (initial)
- 2023-12-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506145-38-00
- EudraCT number
- 2020-003532-25
- ClinicalTrials.gov
- NCT04279847
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Treatment of participants with MF, MDS, ET, or MDS/MPN
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10028537 | Myelofibrosis | 100000004864 |
| 20.0 | PT | 10077465 | Myeloproliferative neoplasm | 100000004864 |
| 21.1 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
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 Trials Information
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trials Information
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 4 | 1 |
| Italy | Ongoing, recruitment ended | 20 | 5 |
| Spain | Ongoing, recruitment ended | 20 | 5 |
| Rest of world
Canada, United Kingdom, United States, Japan
|
— | 172 | — |
Investigational sites
Helsinki University Central Hospital
Department of Hematology, Haartmaninkatu 4, 00290, Helsinki
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
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Dpt of Clinical and Experimental Oncology and Hematology, Via Piero Maroncelli 40, 47014, Meldola
Careggi University Hospital
Departmental Hospital Section (SOD) of Hematology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Hematology department and Head of the Myeloproliferative Syndromes department, Via Francesco Sforza 28, 20122, Milan
Centro Ricerche Cliniche Di Verona S.r.l.
Dpt of Engineering for Innovation Medicine, Biomedicine Section, Hematology Area, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
El Hospital Universitario De Gran Canaria Dr. Negrin
Hematology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
University Clinical Hospital Virgen De La Arrixaca
Hematology, Carretera De Cartagena Sn, El Palmar, Murcia
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
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 |
|---|---|---|---|---|---|
| Finland | 2021-05-11 | 2025-01-28 | |||
| Italy | 2021-06-04 | 2022-01-24 | 2025-09-11 | ||
| Spain | 2022-01-18 | 2022-05-03 | 2025-09-11 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-29 | Italy | Acceptable 2023-12-05
|
2023-12-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-16 | Acceptable 2024-05-21
|
2024-05-23 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-06 | Italy | Acceptable 2024-07-29
|
2024-07-31 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-09 | 2024-08-09 | ||
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-03 | Italy | 2024-09-03 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-28 | Italy | Acceptable 2024-12-20
|
2024-12-20 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-05-02 | Italy | Acceptable 2024-12-20
|
2025-05-02 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-04 | Italy | Acceptable 2025-09-25
|
2025-09-29 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-11-28 | Italy | Acceptable 2026-02-06
|
2026-02-16 |