Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
2,000
Countries
1
Sites
7
Advanced Cancer
Key facts
- Sponsor
- Vaestra Goetalandsregionen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-08-22
- 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
Advanced Cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vaestra Goetalandsregionen
- Sponsor organisation
- Vaestra Goetalandsregionen
- Address
- Regionens Hus
- City
- Vänersborg
- Postcode
- 462 80
- Country
- Sweden
Scientific contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Edvard Abel
Public contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Edvard Abel
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 2,000 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Oncology, Bla Straket 5, Goteborgs Annedal, Goteborg
Karolinska University Hospital
Phase 1 unit, Center for Clinical Cancer Studies, Eugeniavagen 3, 171 64, Solna
Region Uppsala
Blood and tumor diseases, Storgatan 27, Uppsala Domkyrkofors, Uppsala
Region Skane Skanes Universitetssjukhus
Haematology, Halsogatan 3, Lunds Allhelgonafors., Lund
Region Vaesterbotten
Cancer Cantre, Daniel Naezens Vag, 907 37, Umea
Region Oestergoetland
Oncology, Universitetssjukhuset I, 58185, Linkoping
Region Oerebro Laen
Oncology, Sodra Grev Rosengatan, 701 85, Orebro
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-30 | Sweden | Acceptable 2025-08-22
|
2025-08-22 |