Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
375
Countries
8
Sites
27
Ovarian Neoplasms
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited, Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Dec 2024 → ongoing
- Decision date (initial)
- 2024-10-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513860-25-00
- ClinicalTrials.gov
- NCT06431594
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ovarian Neoplasms
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- 79 New Oxford Street
- City
- London
- Postcode
- WC1A 1DG
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
8 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 11 | 1 |
| Finland | Ongoing, recruiting | 18 | 3 |
| France | Ongoing, recruiting | 26 | 3 |
| Germany | Authorised, recruitment pending | 8 | 4 |
| Italy | Ongoing, recruiting | 33 | 5 |
| Netherlands | Ongoing, recruiting | 15 | 1 |
| Spain | Ongoing, recruiting | 20 | 8 |
| Sweden | Ongoing, recruiting | 12 | 2 |
| Rest of world
Canada, Argentina, Korea, Republic of, United Kingdom, United States, Japan, Australia
|
— | 232 | — |
Investigational sites
Tampere University Hospital
FONK (oncological clinical trial unit), Elamanaukio 2, 33520, Tampere
HUS-Yhtymae
HUS Comprehensive Cancer center, Haartmaninkatu 4, 00290, Helsinki
Docrates Oy
Docrates Cancer Center, Saukonpaadenranta 2, 00180, Helsinki
Institut De Cancerologie De L Ouest
Medical oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Technische Universitaet Dresden
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Heidelberg AöR
Klinik für Frauenheilkunde und Geburtshilfe, Im Neuenheimer Feld 672, Neuenheim, Heidelberg
Charite Universitaetsmedizin Berlin KöR
Klinik für Gynäkologie mit Zentrum f onkologische Chirurgie (CVK) u Klinik f Gynäkologie (CBF), Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Ulm AöR
Tumorzentrum Alb-Allgäu-Bodensee Integratives Tumorzentrum, Albert-Einstein-Allee 23, Eselsberg, Ulm
Centro Di Riferimento Oncologico Di Aviano
S.O.C. Oncologia Medica e Prevenzione oncologica (OMP), Via Franco Gallini 2, 33081, Aviano
Istituto Europeo Di Oncologia S.r.l.
Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Humanitas Mirasole S.p.A.
Phase I Clinical Trial Unit, Via Alessandro Manzoni 56, 20089, Rozzano
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Sperimentazioni Cliniche, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità di Fase 1: Unità di Farmacologia Clinica, Largo Francesco Vito 1, 00168, Rome
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Ramon Y Cajal
Oncología Médica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario La Paz
Oncología Médica, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Quironsalud Madrid
Next Oncology – Oncología médica, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Clinica Universidad De Navarra
Oncología Médica, Calle Marquesado De Santa Marta 1, 28027, Madrid
Institut Catala D'oncologia
Oncología Médica, Avinguda De Franca S/n, 17007, Girona
Hospital Universitari Vall D Hebron
Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncología Médica, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Reina Sofia
Oncología Médica, Avenida Menendez Pidal S/n, 14004, Cordoba
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 |
|---|---|---|---|---|---|
| Belgium | 2025-01-09 | 2025-01-09 | |||
| Finland | 2024-12-12 | 2024-12-12 | |||
| France | 2024-12-16 | 2024-12-16 | |||
| Italy | 2024-12-10 | 2024-12-10 | |||
| Netherlands | 2024-12-18 | 2024-12-18 | |||
| Spain | 2024-12-10 | 2024-12-10 | |||
| Sweden | 2024-12-17 | 2024-12-17 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-03 | Belgium | Acceptable with conditions 2024-10-21
|
2024-10-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-28 | Acceptable with conditions 2024-10-21
|
2024-10-28 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-14 | Belgium | Acceptable with conditions 2024-10-21
|
2024-11-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-15 | Belgium | Acceptable 2025-03-03
|
2025-03-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-03-07 | Acceptable 2025-03-03
|
2025-03-07 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-28 | Belgium | Acceptable 2025-06-30
|
2025-06-30 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-30 | Acceptable 2025-06-30
|
2025-07-30 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-21 | Belgium | Acceptable 2025-10-15
|
2025-10-15 |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-11-28 | 2026-02-23 | ||
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-22 | Acceptable | 2026-01-19 |