Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
180
Countries
4
Sites
21
Metastatic melanoma
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
- 31 Mar 2023 → 13 Oct 2025
- Decision date (initial)
- 2023-02-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
| 20.0 | LLT | 10027481 | Metastatic melanoma | 10029104 |
| 21.0 | PT | 10036710 | Primary mediastinal large B-cell lymphoma | 100000004864 |
| 21.1 | PT | 10028997 | Neoplasm malignant | 100000004864 |
| 21.0 | PT | 10060121 | Squamous cell carcinoma of head and neck | 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 Trial Information
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Locations
4 EU/EEA countries · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 40 | 4 |
| France | Ended | 35 | 6 |
| Italy | Ended | 25 | 4 |
| Spain | Ended | 40 | 7 |
| Rest of world
United States
|
— | 40 | — |
Investigational sites
UCL Mont-Godinne
Department of Oncology, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Department of Oncology, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Department of Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Institut Curie
Oncologie medicale, 26 Rue D Ulm, 75005, Paris
Centre De Lutte Contre Le Cancer Eugene Marquis
Oncologie medicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Centre Leon Berard
Oncologie medicale, 28 Rue Laennec, 69008, Lyon
Assistance Publique Hopitaux De Marseille
Oncologie medicale, 264 Rue Saint Pierre, 13005, Marseille
Hopital Saint Louis
Oncologie medicale, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Universitaire Du Cancer Toulouse-Oncopole
Oncologie medicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Azienda Ospedaliera Universitaria Senese
U.O.C. Immunoterapia Oncologica, Strada Delle Scotte 14, 53100, Siena
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology Unit, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology and Hematology, Via Giacomo Venezian 1, 20133, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Melanoma Cancer Immunotherapy and Development Therapeutics Unit, Via Mariano Semmola 52, 80131, Naples
Hospital Universitario Virgen De La Victoria
Oncología, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Clara Campal Comprehesive Cancer Center
Unidad de Fase I-Oncologica, Calle Ona 10, 28050, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario 12 De Octubre
Oncología, Bloque D, Avenida De Cordoba Sn, Madrid
Catalan Institute Of Oncology
Oncology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital General Universitario De Valencia
Servicio de Oncología, Avenida Del Tres Cruces 2, 46014, Valencia
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 | 2023-04-27 | 2025-06-23 | 2023-06-02 | 2024-05-30 | |
| Italy | 2024-04-15 | 2024-06-11 | 2024-05-30 | 2024-05-30 | |
| Spain | 2023-03-31 | 2025-09-23 | 2023-04-11 | 2024-05-30 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-14 | Belgium | Acceptable with conditions 2023-02-17
|
2023-02-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-03-10 | Belgium | Acceptable with conditions | 2023-03-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-03-14 | Acceptable with conditions | 2023-03-28 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-05-03 | Belgium | Acceptable 2023-05-30
|
2023-06-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-10-05 | Belgium | Acceptable 2023-11-17
|
2023-11-21 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2023-12-19 | Acceptable 2023-11-17
|
2024-02-20 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-12-19 | Belgium | Acceptable | 2024-02-13 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-12-21 | Acceptable | 2024-01-22 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2024-01-08 | Acceptable 2023-11-17
|
2024-04-08 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-08-07 | Acceptable | 2024-09-04 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-10-28 | Belgium | Acceptable 2025-01-09
|
2025-01-09 |