Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
115
Countries
2
Sites
7
Patients with tumors
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
- 24 May 2019 → 24 Oct 2025
- Decision date (initial)
- 2024-05-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-510984-52-00
- EudraCT number
- 2018-003659-39
- WHO UTN
- U1111-1302-8405
- ClinicalTrials.gov
- NCT03968653
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
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
- Scientific Contact Point
Public contact point
- Organisation
- Debiopharm International SA
- Contact name
- Public Contact Point
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 88 | 3 |
| Spain | Ended | 27 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Radboud universitair medisch centrum / RADBOUDUMC
Medische Oncologie, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Leids Universitair Medisch Centrum (LUMC)
Clinical Oncology, Albinusdreef 2, 2333 ZA, Leiden
Universitair Medisch Centrum Groningen
Medical Oncology, P. O. Box 30001, 9700 RB, Groningen
Fundacion Instituto Valenciano De Oncologia
Medical Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Vall D'hebron Institut De Recerca
Medical Oncology Department, Passeig De La Vall D'hebron 119-129, 08035, 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 |
|---|---|---|---|---|---|
| Netherlands | 2019-05-24 | 2019-07-23 | 2024-11-11 | ||
| Spain | 2020-06-09 | 2020-06-23 | 2024-09-10 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-22 | Spain | Acceptable 2024-05-23
|
2024-05-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-29 | Spain | Acceptable 2024-11-06
|
2024-11-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-31 | Spain | Acceptable 2025-03-13
|
2025-03-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-23 | Spain | Acceptable 2025-09-24
|
2025-09-24 |