Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
96
Countries
5
Sites
10
Advanced high-grade serous ovarian cancer (OC)
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 10 Jul 2025
- Decision date (initial)
- 2024-11-05
- 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
Advanced high-grade serous ovarian cancer (OC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10033182 | Ovarian germ cell cancer NOS stage IV | 10029104 |
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
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
5 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 2 |
| Germany | Ended | 6 | 1 |
| Italy | Ended | 11 | 2 |
| Netherlands | Ended | 5 | 1 |
| Spain | Ended | 24 | 4 |
| Rest of world
Israel, Switzerland, United States, United Kingdom, Japan
|
— | 38 | — |
Investigational sites
Centre Leon Berard
1002:Oncologie Medical, 28 Rue Laennec, 69008, Lyon
Institut De Cancerologie De L Ouest
1001:Medecine nucleaire, Bd Du Professeur Jacques Monod, 44800, St Herblain
Universitaetsklinikum Essen AöR
1101:Klinik für Nuklearmedizin, Hufelandstrasse 55, Holsterhausen, Essen
Fondazione IRCCS Istituto Nazionale Dei Tumori
1301 S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda USL IRCCS Di Reggio Emilia
1302 S.C. Oncologia Medica, Viale Risorgimento 80, 42123, Reggio Emilia
Stichting Radboud universitair medisch centrum
1401:Beeldvorming, sectie Nuclaire Geneeskunde, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Hospital Universitario 12 De Octubre
1502 Oncología, Bloque D, Avenida De Cordoba Sn, Madrid
Institut Catala D'oncologia
1501 Oncología, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Ramon Y Cajal
1503 Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Clinic De Barcelona
1504 Oncología, Calle Villarroel 170, 08036, Barcelona
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | Italy | Acceptable with conditions 2024-11-04
|
2024-11-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-23 | Italy | Acceptable with conditions 2024-11-04
|
2025-01-23 |