Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
122
Countries
4
Sites
6
Metastatic Pancreatic Adenocarcinoma
Key facts
- Sponsor
- Ipsen Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 May 2022 → 16 Apr 2025
- Decision date (initial)
- 2024-10-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516760-28-00
- EudraCT number
- 2021-003264-26
- ClinicalTrials.gov
- NCT05383352
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic Pancreatic Adenocarcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10033599 | Pancreatic adenocarcinoma metastatic | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ipsen Pharma
- Sponsor organisation
- Ipsen Pharma
- Address
- 65 Quai Georges Gorse
- City
- Boulogne Billancourt
- Postcode
- 92100
- Country
- France
Scientific contact point
- Organisation
- Ipsen Pharma
- Contact name
- Medical Development Director (or Medical Director for GMA studies)
Public contact point
- Organisation
- Ipsen Pharma
- Contact name
- Ipsen Clinical Study Enquiries
Locations
4 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 25 | 1 |
| Hungary | Ended | 30 | 1 |
| Italy | Ended | 25 | 1 |
| Spain | Ended | 40 | 3 |
| Rest of world
Australia
|
— | 2 | — |
Investigational sites
Semmelweis University
Belgyógyászati és Onkológiai Klinika (Klinikai Farmakológiai részleg), Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
S.C. Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Hospital Universitari Vall D Hebron
Oncology department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Marques De Valdecilla
Oncology department, Avenida Valdecilla Sn, 39008, Santander
MD Anderson Cancer Center
Cancer center, Calle De Arturo Soria Nº 270, 28033, 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 |
|---|---|---|---|---|---|
| France | 2022-05-09 | 2025-03-26 | 2022-06-07 | 2024-02-26 | |
| Hungary | 2022-06-07 | 2025-03-10 | 2022-08-02 | 2024-02-20 | |
| Italy | 2023-03-13 | 2024-11-15 | 2023-04-27 | 2024-04-29 | |
| Spain | 2022-05-04 | 2025-04-15 | 2022-05-30 | 2024-04-23 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-23 | Spain | Acceptable 2024-10-14
|
2024-10-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-18 | Spain | Acceptable 2025-02-17
|
2025-02-17 |