Overview
Sponsor-declared trial summary
Arm A: Diagnosed with uterine serous carcinoma (USC) Arm B: Diagnosed with recurrent or progressive, high-grade epithelial ovarian cancer (EOC) with cyclin E1-driven selection Arm C: Diagnosed with solid tumor with biomarker-driven selection
Key facts
- Sponsor
- Debiopharm International S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Mar 2024 → 24 Apr 2026
- Decision date (initial)
- 2024-02-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504824-24-00
- WHO UTN
- U1111-1290-2185
- ClinicalTrials.gov
- NCT05109975
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Arm A: Diagnosed with uterine serous carcinoma (USC) Arm B: Diagnosed with recurrent or progressive, high-grade epithelial ovarian cancer (EOC) with cyclin E1-driven selection Arm C: Diagnosed with solid tumor with biomarker-driven selection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 20.0 | LLT | 10046769 | Uterine carcinoma | 10029104 |
| 20.0 | PT | 10061328 | Ovarian epithelial cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Debiopharm International S.A.
- Sponsor organisation
- Debiopharm International S.A.
- Address
- Chemin Messidor 5-7
- City
- Lausanne
- Postcode
- 1006
- Country
- Switzerland
Scientific contact point
- Organisation
- Debiopharm International S.A.
- Contact name
- Debiopharm International S.A / Clinical department
Public contact point
- Organisation
- Debiopharm International S.A.
- Contact name
- Debiopharm International S.A / Clinical department
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 47 | 9 |
| Rest of world
United States, Switzerland
|
— | 113 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2024-03-15 | 2024-04-24 | 2026-01-13 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-17 | Spain | Acceptable 2024-02-21
|
2024-02-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-26 | Spain | Acceptable 2024-06-14
|
2024-06-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-14 | Spain | Acceptable 2024-09-24
|
2024-09-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-15 | Spain | Acceptable 2025-02-07
|
2025-02-07 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-12 | Spain | Acceptable 2025-06-13
|
2025-06-13 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-29 | Spain | Acceptable 2025-09-12
|
2025-09-15 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-19 | Spain | Acceptable | 2025-12-01 |