Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
34
Countries
3
Sites
6
Ovarian cancer Primary peritoneal cancer Fallopian tube cancer
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Jan 2026 → ongoing
- Decision date (initial)
- 2026-01-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ovarian cancer Primary peritoneal cancer Fallopian tube cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 24.1 | LLT | 10086155 | Primary peritoneal carcinosarcoma | 100000004848 |
| 20.0 | PT | 10016180 | Fallopian tube cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Ireland | Ongoing, recruiting | 13 | 1 |
| Portugal | Ongoing, recruiting | 4 | 1 |
| Spain | Ongoing, recruiting | 17 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Mater Misericordiae University Hospital
3901: START Dublin, Eccles Street, D07 R2WY, Dublin 7
Start Research Portugal Unipessoal Lda.
351217805000, Rua Castilho 39 8º E, 1250-068, Lisbon
Hospital Universitario Hm Sanchinarro
7001: CIOCC Phase I Unit, Calle Ona 10, 28050, Madrid
Fundacion Rioja Salud
7003: Early Phase Clinical Trials, Calle Piqueras 98, 26006, Logrono
Hospital Universitario Fundacion Jimenez Diaz
7004: Phase I Clinical Trials Unit, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Hm Nou Delfos
7002: CIOCC Early Phase, Avinguda De Vallcarca 151, 08023, Barcelona
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 |
|---|---|---|---|---|---|
| Ireland | 2026-02-05 | 2026-02-09 | |||
| Portugal | 2026-02-17 | 2026-03-02 | |||
| Spain | 2026-01-23 | 2026-01-26 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-12 | Spain | Acceptable 2026-01-14
|
2026-01-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-22 | Spain | Acceptable 2026-01-14
|
2026-01-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-23 | Acceptable | 2026-02-10 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-27 | Spain | Acceptable | 2026-04-27 |