Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
30
Countries
1
Sites
6
pancreatic ductal adenocarcinoma
Key facts
- Sponsor
- Peptomyc S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Aug 2023 → ongoing
- Decision date (initial)
- 2023-07-24
- 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
pancreatic ductal adenocarcinoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Peptomyc S.L.
- Sponsor organisation
- Peptomyc S.L.
- Address
- Calle Natzaret 115
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Peptomyc S.L.
- Contact name
- Manuela Niewel
Public contact point
- Organisation
- Peptomyc S.L.
- Contact name
- Manuela Niewel
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 30 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital General Universitario Gregorio Maranon
Oncology Service, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Unviersitario Miguel Servet
Oncology Service, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Regional De Malaga
Oncology service, Avenida De Carlos De Haya Sn, 29010, Malaga
Institut Catala D'oncologia
Oncology Service, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Marques De Valdecilla
Oncology service, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitari Vall D Hebron
Oncology Service, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, 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 |
|---|---|---|---|---|---|
| Spain | 2023-08-28 | 2023-09-07 | 2025-06-29 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-21 | Spain | Acceptable 2023-07-24
|
2023-07-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-27 | Spain | Acceptable 2024-05-30
|
2024-05-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-24 | Spain | Acceptable 2024-09-09
|
2024-09-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-11 | Spain | Acceptable 2025-02-04
|
2025-02-04 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-06 | Spain | Acceptable 2025-09-30
|
2025-10-09 |