Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
60
Countries
1
Sites
4
Advanced solid tumors
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Jul 2023 → 21 Jan 2025
- Decision date (initial)
- 2024-05-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503547-33-00
- EudraCT number
- 2020-003547-28
- ClinicalTrials.gov
- NCT04999202
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- Kaiser-Wilhelm-Allee 1, Wiesdorf Wiesdorf
- City
- Leverkusen
- Postcode
- 51373
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 15 | 4 |
| Rest of world
United Kingdom, Singapore, United States
|
— | 45 | — |
Investigational sites
Humanitas Research Hospital
Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
European Institute Of Oncology S.r.l.
Sviluppo Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Sperimentazioni Cliniche, Via Mariano Semmola 52, 80131, Naples
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 |
|---|---|---|---|---|---|
| Italy | 2023-07-12 | 2025-01-20 | 2023-07-20 | 2023-11-16 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-02 | Italy | Acceptable 2024-05-03
|
2024-05-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-13 | Italy | Acceptable 2024-05-03
|
2024-06-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-28 | Italy | Acceptable 2025-01-22
|
2025-01-24 |