Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
28
Countries
1
Sites
6
Advanced Pancreatic Cancer
Key facts
- Sponsor
- Nelum Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Sep 2021 → 28 Apr 2025
- Decision date (initial)
- 2024-10-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518852-22-00
- EudraCT number
- 2020-004932-52
- ClinicalTrials.gov
- NCT04827953
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Pancreatic Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10033605 | Pancreatic cancer metastatic | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nelum Corp.
- Sponsor organisation
- Nelum Corp.
- Address
- 5000 Centre Green Way Suite 500
- City
- Cary
- Postcode
- 27513-5821
- Country
- United States
Scientific contact point
- Organisation
- Nelum Corp.
- Contact name
- Clinical Operations Department
Public contact point
- Organisation
- Nelum Corp.
- Contact name
- Clinical Operations Department
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 28 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Complexo Hospitalario Universitario De Santiago
Oncologia, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Marques De Valdecilla
Oncología, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitari Vall D Hebron
Gastrointestinal and endocrine tumor unit, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Donostia
Oncologia, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitario Virgen De La Victoria
Oncologia, Calle Del Arroyo Teatinos S/N, 29010, Malaga
Hospital Universitario Miguel Servet
Medical Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
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 | 2021-09-03 | 2025-04-28 | 2021-10-01 | 2024-05-03 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-09 | Spain | Acceptable 2024-10-23
|
2024-10-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-17 | Spain | Acceptable 2025-05-23
|
2025-05-23 |