Clinical trial • Phase I • Oncology

GSK5733584 for Injection for Ovarian cancer

Phase I trial of GSK5733584 for Injection for Ovarian cancer. 232 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Ovarian cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
03-07-2024
First CTIS Authorization Date
22-10-2024

Trial design

Phase I trial across 27 sites in Netherlands, Sweden, Italy and others.

Target Sample Size
232

Recruitment

Planned Sample Size
232
Recruitment Window Months
34

Geography

Total Number Of Sites
27
Total Number Of Participants
143

Netherlands

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
23-10-2024
Processing Time Days
9
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
Marloes van Dongen
Contact Person Email
fase1@nki.nl

Sweden

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
24-10-2024
Processing Time Days
94
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Uppsala University Hospital
Department Name
KFUE - Kliniska forsknings- och utvecklingsenheten, Blod- och Tumörsjukdomar
Contact Person Name
Anthoula Koliadi
Site Name
Karolinska University Hospital
Department Name
Centrum för Kliniska Cancerstudier Tema Cancer
Contact Person Name
Lisa Liu Burström

Italy

Earliest CTIS Part Ii Submission Date
04-10-2024
Latest Decision Or Authorization Date
22-10-2024
Processing Time Days
18
Number Of Sites
5
Number Of Participants
33

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Sperimentazioni Cliniche
Contact Person Name
Adriano Gravina
Contact Person Email
a.gravina@istitutotumori.na.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Phase I Clinical Trial Unit
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unità di Fase 1: Unità di Farmacologia Clinica
Contact Person Name
Vanda Salutari
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
S.O.C. Oncologia Medica e Prevenzione oncologica (OMP)
Contact Person Name
Michele Bartoletti
Contact Person Email
michele.bartoletti@cro.it

Belgium

Earliest CTIS Part Ii Submission Date
01-10-2024
Latest Decision Or Authorization Date
25-10-2024
Processing Time Days
24
Number Of Sites
1
Number Of Participants
11

Sites

Site Name
UZ Leuven
Department Name
Gynaecological oncology
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be

France

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
24-10-2024
Processing Time Days
27
Number Of Sites
3
Number Of Participants
26

Sites

Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Contact Person Name
Alexandra LEARY
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical oncology
Contact Person Name
Jean-Sebastien FRENEL
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Isabelle RAY-COQUARD

Finland

Earliest CTIS Part Ii Submission Date
23-09-2024
Latest Decision Or Authorization Date
23-10-2024
Processing Time Days
30
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Tampere University Hospital
Department Name
FONK (oncological clinical trial unit)
Contact Person Name
Synnöve Staff
Contact Person Email
etunimi.sukunimi@pirha.fi
Site Name
HUS-Yhtymae
Department Name
HUS Comprehensive Cancer center
Contact Person Name
Katriina Jalkanen
Contact Person Email
etunimi.sukunimi@hus.fi
Site Name
Docrates Oy
Department Name
Docrates Cancer Center
Contact Person Name
Johanna Mäenpää
Contact Person Email
etunimi.sukunimi@docrates.com

Germany

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
17
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Gynäkologie mit Zentrum f onkologische Chirurgie (CVK) u Klinik f Gynäkologie (CBF)
Contact Person Name
Elena Braicu
Contact Person Email
elena.braicu@charite.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Tumorzentrum Alb-Allgäu-Bodensee Integratives Tumorzentrum
Contact Person Name
Sabine Heublein
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Pauline Wimberger
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Katharina Smetanay

Spain

Earliest CTIS Part Ii Submission Date
02-10-2024
Latest Decision Or Authorization Date
22-10-2024
Processing Time Days
20
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Institut Catala D'oncologia
Department Name
Oncología Médica
Contact Person Name
Pilar Barretina Ginesta
Contact Person Email
mpbarretina@iconcologia.net
Site Name
Clinica Universidad De Navarra
Department Name
Oncología Médica
Contact Person Name
Antonio González Martín
Contact Person Email
ensayoscun@unav.es
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncología Médica
Contact Person Name
María Jesús Rubio Pérez
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Oncología Médica
Contact Person Name
Andrés Redondo Sánchez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología Médica
Contact Person Name
Lorena Fariñas Madrid
Contact Person Email
lfarinas@vhio.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología Médica
Contact Person Name
Eva María Guerra Alía
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Next Oncology – Oncología médica
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncología Médica
Contact Person Name
Victor Moreno García
Contact Person Email
victor.moreno@startmadrid.com

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Investigational products

Investigational Product Name
GSK5733584 for Injection
Routes Of Administration
for Injection
Route
for Injection

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