Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
31
Countries
4
Sites
9
Metastatic neuroendocrine prostate cancer
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Jul 2024 → ongoing
- Decision date (initial)
- 2024-05-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505655-43-00
- ClinicalTrials.gov
- NCT06379217
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic neuroendocrine prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | PT | 10087499 | Neuroendocrine cancer of the prostate metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
4 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 5 | 3 |
| Germany | Ongoing, recruitment ended | 3 | 2 |
| Italy | Ended | 4 | 2 |
| Spain | Ongoing, recruitment ended | 8 | 2 |
| Rest of world
United Kingdom, United States
|
— | 11 | — |
Investigational sites
Centre Hospitalier Universitaire De Lille
#1002: Medecine Nucléaire, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Nantes
#1003: Medecine Nucléaire, 1 Place Alexis Ricordeau, 44000, Nantes
CHRU De Nancy
#1001: Medecine Nucléaire, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Klinikum rechts der Isar der TU Muenchen AöR
#1101: Klinik und Poliklinik für Nuklearmedizin, Ismaninger Strasse 22, Au-Haidhausen, Munich
Rostock University Medical Center
#1102: Klinik und Poliklinik für Nuklearmedizin, Gertrudenplatz 1, Kroepeliner Tor Vorstadt, Rostock
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
#1202: Diagnostic Nuclear Medicine, Via Piero Maroncelli 40, 47014, Meldola
Azienda USL IRCCS Di Reggio Emilia
#1201: Nuclear Medicine, Viale Risorgimento 80, 42123, Reggio Emilia
Hospital Universitario 12 De Octubre
#1302: Oncologia, Bloque D, Avenida De Cordoba Sn, Madrid
Institut Catala D'oncologia
#1301: Oncologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 | 2024-07-29 | 2024-07-29 | 2025-10-20 | ||
| Germany | 2025-08-01 | 2025-08-01 | 2026-01-12 | ||
| Italy | 2025-09-05 | 2025-12-30 | 2025-09-05 | 2025-12-09 | |
| Spain | 2024-07-30 | 2024-07-30 | 2025-11-14 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-25 | Germany | Acceptable 2024-05-07
|
2024-05-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-04 | Germany | Acceptable 2024-08-26
|
2024-08-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-29 | Germany | Acceptable 2025-01-16
|
2025-01-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-23 | Germany | Acceptable 2025-07-28
|
2025-07-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-21 | Germany | Acceptable 2025-12-03
|
2025-12-03 |