Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
1
Countries
1
Sites
1
Patients with relapsed or refractory solid tumors, including: Small cell lung cancer (SCLC); Non-small cell cancer (NSCLC); Breast cancer
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Mar 2021 → 12 Sep 2025
- Decision date (initial)
- 2024-07-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513625-23-00
- EudraCT number
- 2020-002495-12
- ClinicalTrials.gov
- NCT03595059
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with relapsed or refractory solid tumors, including: Small cell lung cancer (SCLC); Non-small cell cancer (NSCLC); Breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065143 | Malignant solid tumour | 10029104 |
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
| 21.1 | PT | 10029515 | Non-small cell lung cancer recurrent | 100000004864 |
| 21.1 | PT | 10041070 | Small cell lung cancer recurrent | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 1 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
N/A, Heidelberglaan 100, 3584 CX, Utrecht
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 | 2021-03-15 | 2025-09-12 | 2021-04-18 | 2022-08-18 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-28 | Netherlands | Acceptable with conditions 2024-07-18
|
2024-07-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-15 | Netherlands | Acceptable with conditions 2024-07-18
|
2025-09-15 |