Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
66
Countries
1
Sites
1
Advanced malignancies.
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
- 15 Sep 2022 → 10 Sep 2025
- Decision date (initial)
- 2024-08-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504400-29-00
- EudraCT number
- 2020-004867-26
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced malignancies.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10075333 | Soft tissue sarcoma | 100000004864 |
| 21.1 | PT | 10029522 | Non-small cell lung cancer stage IV | 100000004864 |
| 27.0 | PT | 10027480 | Metastatic malignant melanoma | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 27.0 | PT | 10044406 | Transitional cell cancer of renal pelvis and ureter metastatic | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
| 21.1 | LLT | 10077840 | Urothelial cancer of renal pelvis | 10029104 |
| 21.1 | PT | 10067821 | Head and neck cancer | 100000004864 |
| 21.1 | PT | 10025671 | Malignant melanoma stage IV | 100000004864 |
| 27.0 | PT | 10063916 | Metastatic gastric cancer | 100000004864 |
| 27.0 | PT | 10071540 | Head and neck cancer metastatic | 100000004864 |
| 27.0 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
| 26.1 | 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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 9 | 1 |
| Rest of world
United States
|
— | 57 | — |
Investigational sites
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2022-09-15 | 2025-09-10 | 2022-10-04 | 2023-04-19 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-06 | Netherlands | Acceptable with conditions 2024-08-30
|
2024-08-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-23 | Netherlands | Acceptable with conditions 2024-08-30
|
2025-04-23 |