Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
78
Countries
1
Sites
12
Small cell lung cancer
Key facts
- Sponsor
- Debiopharm International SA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Mar 2023 → 10 Mar 2026
- Decision date (initial)
- 2024-07-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-510980-40-00
- EudraCT number
- 2022-001976-32
- WHO UTN
- U1111-1302-8787
- ClinicalTrials.gov
- NCT05815160
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Small cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Debiopharm International SA
- Sponsor organisation
- Debiopharm International SA
- Address
- Forum Apres-Demain, Chemin Messidor 5-7 Chemin Messidor 5-7
- City
- Lausanne
- Postcode
- 1006
- Country
- Switzerland
Scientific contact point
- Organisation
- Debiopharm International SA
- Contact name
- Clinical department
Public contact point
- Organisation
- Debiopharm International SA
- Contact name
- Clinical department
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 50 | 12 |
| Rest of world
United States
|
— | 28 | — |
Investigational sites
Clinica Universidad De Navarra
Medical Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Complexo Hospitalario Universitario A Coruna
Medical Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Institut Catala D'oncologia
Medical Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Clinica Universidad De Navarra
Medical Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
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 | 2023-03-09 | 2023-05-02 | 2025-07-21 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-92673
- Halt date
- 2025-07-21
- Member states concerned
- Spain
- Publication date
- 2025-07-31
- Reason
- Safety related (clinical or pre-clinical results)
- Follow-up measures
- No follow-up measures for subjects are considered necessary.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-21 | Spain | Acceptable with conditions 2024-07-12
|
2024-07-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-06 | Spain | Acceptable 2024-10-21
|
2024-11-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-31 | Spain | Acceptable 2025-03-14
|
2025-03-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-16 | Spain | Acceptable | 2025-05-22 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-23 | Spain | Acceptable 2025-11-07
|
2025-11-12 |