Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
53
Countries
1
Sites
4
BRAF V600E mutated colorectal cancer
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518419-20-00
- EudraCT number
- 2020-003283-10
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
BRAF V600E mutated colorectal cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Sponsor/PI Camilla Qvortrup
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Sponsor/PI Camilla Qvortrup
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 53 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Nordsjaellands Hospital
Department of Oncology, Dyrehavevej 29, 3400, Hilleroed
Aalborg University Hospital
Department of Oncology, Hobrovej 18-22, 9000, Aalborg
Odense University Hospital
Department of Oncology, J B Winsloews Vej 4, 5000, Odense C
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 |
|---|---|---|---|---|---|
| Denmark | 2024-10-23 | 2024-10-23 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-27 | Denmark | Acceptable 2024-10-23
|
2024-10-23 |