Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
20
Countries
1
Sites
5
Patients with breast cancer, colorectal cancer, oesophageal cancer and pancreatic adenocarcinoma.
Key facts
- Sponsor
- Philogen S.p.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Apr 2023 → 26 Apr 2024
- Decision date (initial)
- 2022-11-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500902-16-00
- ClinicalTrials.gov
- NCT05784597
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with breast cancer, colorectal cancer, oesophageal cancer and pancreatic adenocarcinoma.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Philogen S.p.A.
- Sponsor organisation
- Philogen S.p.A.
- Address
- Piazza La Lizza 7
- City
- Siena
- Postcode
- 53100
- Country
- Italy
Scientific contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Jacqueline Mock
Public contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Jacqueline Mock
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 20 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Ospedaliero Universitaria Pisana
Medicina Nucleare, Via Roma 67, 56126, Pisa
National Cancer Institute
Diagnostica per Immagini e radioterapia/Medicina Nucleare, Via Giacomo Venezian 1, 20133, Milan
Humanitas Research Hospital
Medicina Nucleare, Via Alessandro Manzoni 56, 20089, Rozzano
Ospedale San Raffaele S.r.l.
Medicina Nucleare, Via Olgettina 60, 20132, Milan
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Medicina Nucleare, Via Piero Maroncelli 40, 47014, Meldola
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 |
|---|---|---|---|---|---|
| Italy | 2023-04-27 | 2024-04-26 | 2023-11-07 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-07-21 | Italy | Acceptable 2022-11-07
|
2022-11-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-02-16 | Italy | Acceptable | 2023-03-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-06-22 | Italy | Acceptable 2023-08-07
|
2023-08-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-11-20 | Italy | Acceptable 2023-12-29
|
2024-01-25 |