Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
233
Countries
3
Sites
9
Advanced solid tumors
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
- 29 Jun 2017 → 5 Jul 2025
- Decision date (initial)
- 2024-04-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508925-29-00
- EudraCT number
- 2016-001861-10
- ClinicalTrials.gov
- NCT03114319
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| 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
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 5 | 1 |
| Netherlands | Ended | 33 | 3 |
| Spain | Ended | 75 | 5 |
| Rest of world
United States, Canada, Taiwan, Korea, Republic of, Singapore, Japan
|
— | 120 | — |
Investigational sites
European Institute Of Oncology S.r.l.
3500:Divisione Sviluppo Nuovi Farmaci per Terapie Innovative - Oncologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
3000: Oncologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Leids Universitair Medisch Centrum (LUMC)
3002: Oncologie, Albinusdreef 2, 2333 ZA, Leiden
Netherlands Cancer Institute
3001: Oncologie, Plesmanlaan 121, 1066 CX, Amsterdam
Institut Catala D'oncologia
6001:Oncologia Médica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
6000:Oncologia Médica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Ramon Y Cajal
6003:Oncologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital General Universitario Gregorio Maranon
6002:Oncologia Médica, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Fundacion Jimenez Diaz
6004:Oncologia Médica, Avenida De Los Reyes Catolicos 2, 28040, 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 |
|---|---|---|---|---|---|
| Italy | 2023-07-10 | 2023-07-10 | 2024-05-13 | ||
| Netherlands | 2017-06-29 | 2017-06-29 | 2024-05-13 | ||
| Spain | 2017-06-06 | 2017-06-06 | 2024-05-13 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 3 · Art. 38 CTR
Temporary halt TH-25597
- Halt date
- 2024-05-13
- Member states concerned
- Spain
- Publication date
- 2024-05-17
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-25595
- Halt date
- 2024-05-13
- Member states concerned
- Netherlands
- Publication date
- 2024-05-17
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-25603
- Halt date
- 2024-05-13
- Member states concerned
- Italy
- Publication date
- 2024-05-17
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-15 | Spain | Acceptable 2024-04-10
|
2024-04-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-28 | Spain | Acceptable 2024-04-10
|
2024-10-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-03 | Spain | Acceptable | 2025-01-21 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-27 | Spain | Acceptable | 2025-02-27 |