Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
177
Countries
4
Sites
7
Advanced relapsed or refractory ovarian cancer
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 May 2026 → ongoing
- Decision date (initial)
- 2026-04-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522913-45-00
- WHO UTN
- U1111-1324-5961
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced relapsed or refractory ovarian cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
Scientific contact point
- Organisation
- Boehringer Ingelheim Espana S.A.
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim Espana S.A.
- Contact name
- CT Disclosure & Data Transparency
Locations
4 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruiting | 9 | 1 |
| France | Authorised, recruiting | 28 | 2 |
| Germany | Authorised, recruiting | 28 | 2 |
| Spain | Authorised, recruiting | 37 | 2 |
| Rest of world
Japan, United States
|
— | 75 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Department of Oncology, route 42, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Institut Gustave Roussy
Département de Médecine Oncologique, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Paoli Calmettes
Oncologie Médicale, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
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 |
|---|---|---|---|---|---|
| Belgium | 2026-05-27 | ||||
| France | 2026-05-21 | ||||
| Germany | 2026-05-21 | ||||
| Spain | 2026-05-22 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-16 | Germany | Acceptable 2026-04-20
|
2026-04-20 |