Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
151
Countries
5
Sites
6
Advanced mesothelioma or other solid tumors harboring certain molecular alterations in the Hippo pathway
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
- 7 Dec 2021 → ongoing
- Decision date (initial)
- 2024-02-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508369-34-00
- EudraCT number
- 2021-000383-30
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced mesothelioma or other solid tumors harboring certain molecular alterations in the Hippo pathway
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- 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 · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 8 | 1 |
| Germany | Ongoing, recruitment ended | 8 | 1 |
| Italy | Ongoing, recruitment ended | 40 | 2 |
| Netherlands | Ongoing, recruitment ended | 10 | 1 |
| Spain | Ongoing, recruitment ended | 23 | 1 |
| Rest of world
Switzerland, Canada, Japan, Australia, United Kingdom, United States
|
— | 62 | — |
Investigational sites
Institut Gustave Roussy
4001: Innovations Thérapeutiques et Essais Précoces, 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsklinikum Essen AöR
3001: Westdeutsches Tumorzentrum, Hufelandstrasse 55, Holsterhausen, Essen
Fondazione IRCCS Istituto Nazionale Dei Tumori
6002: S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Humanitas Research Hospital
6001: U.O. di Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
7001: Pulmonary Department, Dr. Molewaterplein 40, 3015 GD, Rotterdam
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 | 2023-03-14 | 2023-03-14 | 2024-11-19 | ||
| Germany | 2022-05-03 | 2022-05-03 | 2024-10-30 | ||
| Italy | 2022-03-21 | 2022-03-21 | 2024-11-14 | ||
| Netherlands | 2023-03-03 | 2023-03-03 | 2025-01-24 | ||
| Spain | 2021-12-07 | 2021-12-07 | 2024-10-23 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-20 | Italy | Acceptable 2024-02-20
|
2024-02-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-31 | Italy | Acceptable 2024-02-20
|
2024-05-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-30 | Italy | Acceptable 2025-01-13
|
2025-01-13 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-27 | Italy | Acceptable 2025-01-13
|
2025-01-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-14 | Italy | Acceptable 2025-05-28
|
2025-05-28 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-16 | Acceptable | 2025-07-11 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-29 | Italy | Acceptable 2025-11-10
|
2025-11-12 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-11 | Acceptable | 2026-01-13 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-27 | Italy | Acceptable 2026-05-06
|
2026-05-07 |