Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
130
Countries
7
Sites
9
adenocarcinoma of the colon or rectum
Key facts
- Sponsor
- Bayer Consumer Care AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-06-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
adenocarcinoma of the colon or rectum
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10052360 | Colorectal adenocarcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer Consumer Care AG
- Sponsor organisation
- Bayer Consumer Care AG
- Address
- Peter Merian-Strasse 84
- City
- Basel
- Postcode
- 4052
- Country
- Switzerland
Scientific contact point
- Organisation
- Bayer Consumer Care AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer Consumer Care AG
- Contact name
- Therapeutic Area Head
Locations
7 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 7 | 1 |
| Denmark | Authorised, recruitment pending | 10 | 2 |
| Finland | Authorised, recruitment pending | 4 | 1 |
| Italy | Authorised, recruitment pending | 10 | 1 |
| Netherlands | Authorised, recruitment pending | 4 | 1 |
| Spain | Authorised, recruitment pending | 7 | 2 |
| Sweden | Authorised, recruitment pending | 7 | 1 |
| Rest of world
United States, Singapore, Australia
|
— | 81 | — |
Investigational sites
Universitair Ziekenhuis Gent
Drug Research Unit Department, Corneel Heymanslaan 10, 9000, Gent
Rigshospitalet
Kræftbehandling, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Oncology Department, J. B. Winsloews Vej 4, 5000, Odense C
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase I, Largo Francesco Vito 1, 00168, Rome
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Nederlands Kanker Instituut, Plesmanlaan 121, 1066 CX, Amsterdam
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-23 | Denmark | Acceptable 2026-06-08
|
2026-06-08 |