Clinical trial • Phase I • Oncology

LOXO-783 for Advanced breast cancer | Solid tumors

Phase I trial of LOXO-783 for Advanced breast cancer | Solid tumors. None/Not specified-controlled. 300 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced breast cancer | Solid tumors
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
31-05-2024
First CTIS Authorization Date
08-07-2024

Trial design

None/Not specified-controlled Phase I trial across 21 sites in Belgium, France, Germany and others.

Comparator
None/Not specified
Target Sample Size
300

Recruitment

Planned Sample Size
300
Recruitment Window Months
87

Geography

Total Number Of Sites
21
Total Number Of Participants
100

Belgium

Latest Decision Or Authorization Date
08-07-2024
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Institut Jules Bordet
Department Name
Oncology
Principal Investigator Name
Philippe Aftimos
Principal Investigator Email
philippe.aftimos@bordet.be
Contact Person Name
Philippe Aftimos
Contact Person Email
philippe.aftimos@bordet.be
Site Name
UZ Leuven
Department Name
Gynecological Oncology, Breast Center
Principal Investigator Name
Patrick Neven
Principal Investigator Email
Patrick.neven@uzleuven.be
Contact Person Name
Patrick Neven
Contact Person Email
Patrick.neven@uzleuven.be

France

Latest Decision Or Authorization Date
10-07-2024
Number Of Sites
7
Number Of Participants
32

Sites

Site Name
Institut Curie
Department Name
medical oncology
Principal Investigator Name
Francois-Clement Bidard
Principal Investigator Email
francois-clement.bidard@curie.fr
Contact Person Name
Francois-Clement Bidard
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
medical oncology
Principal Investigator Name
Philippe Barthelemy
Principal Investigator Email
p.barthelemy@icans.eu
Contact Person Name
Philippe Barthelemy
Contact Person Email
p.barthelemy@icans.eu
Site Name
Institut De Cancerologie De L Ouest
Department Name
medical oncology
Principal Investigator Name
Mario Campone
Principal Investigator Email
Mario.Campone@ico.unicancer.fr
Contact Person Name
Mario Campone
Contact Person Email
Mario.Campone@ico.unicancer.fr
Site Name
Institut Curie
Department Name
medical oncology
Principal Investigator Name
Francois-Clement Bidard
Principal Investigator Email
francois-clement.bidard@curie.fr
Contact Person Name
Francois-Clement Bidard
Site Name
Centre Leon Berard
Department Name
medical oncology
Principal Investigator Name
Hélène Vanacker
Principal Investigator Email
helene.vanacker@lyon.unicancer.fr
Contact Person Name
Hélène Vanacker
Site Name
Institut Gustave Roussy
Department Name
medical oncology
Principal Investigator Name
Barbara Pistilli
Principal Investigator Email
barbara.pistilli@gustaveroussy.fr
Contact Person Name
Barbara Pistilli
Site Name
Centre Francois Baclesse
Department Name
breast pathology
Principal Investigator Name
George Emile
Principal Investigator Email
g.emile@baclesse.unicancer.fr
Contact Person Name
George Emile
Contact Person Email
g.emile@baclesse.unicancer.fr

Germany

Latest Decision Or Authorization Date
09-07-2024
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Department of Gynecology and Obstetrics, Frauenklinik, Universitätsklinikum Erlangen
Principal Investigator Name
Peter Fasching
Principal Investigator Email
peter.fasching.studien@uk-erlangen.de
Contact Person Name
Peter Fasching
Site Name
Goethe University Frankfurt
Department Name
Med. Klinik II, Universitätsklinikum Frankfurt
Principal Investigator Name
Martin Sebastian
Principal Investigator Email
sebastian@med.uni-frankfurt.de
Contact Person Name
Martin Sebastian
Contact Person Email
sebastian@med.uni-frankfurt.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik-Innere Medizin VIII, Universitätsklinikum Tübingen
Principal Investigator Name
Ulrich M. Lauer
Principal Investigator Email
ulrich.lauer@med.uni-tuebingen.de
Contact Person Name
Ulrich M. Lauer

Italy

Latest Decision Or Authorization Date
10-07-2024
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
Principal Investigator Name
Giuseppe Curigliano
Principal Investigator Email
giuseppe.curigliano@ieo.it
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it

Spain

Latest Decision Or Authorization Date
10-07-2024
Number Of Sites
8
Number Of Participants
33

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Yolanda Jerez Gilarranz
Principal Investigator Email
yolanda.jerez@saludmadrid.org
Contact Person Name
Yolanda Jerez Gilarranz
Contact Person Email
yolanda.jerez@saludmadrid.org
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Eva Ciruelos Gil
Principal Investigator Email
eva.ciruelos@gmail.com
Contact Person Name
Eva Ciruelos Gil
Contact Person Email
eva.ciruelos@gmail.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology
Principal Investigator Name
Valentina Boni
Principal Investigator Email
vboni@nextoncology.eu
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Principal Investigator Name
Javier Cortes Castan
Principal Investigator Email
javier.cortes@maj3.health
Contact Person Name
Javier Cortes Castan
Contact Person Email
javier.cortes@maj3.health
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Begoña Bermejo de las Heras
Principal Investigator Email
begobermejo@gmail.com
Contact Person Name
Begoña Bermejo de las Heras
Contact Person Email
begobermejo@gmail.com
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
Oncology
Principal Investigator Name
Antonio Llombart Cussac
Principal Investigator Email
allombart1@yahoo.com
Contact Person Name
Antonio Llombart Cussac
Contact Person Email
allombart1@yahoo.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Ivan Victoria Ruiz
Principal Investigator Email
ivictori@recerca.clinic.cat
Contact Person Name
Ivan Victoria Ruiz
Contact Person Email
ivictori@recerca.clinic.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Cristina Saura Manich
Principal Investigator Email
csaura@vhio.net
Contact Person Name
Cristina Saura Manich
Contact Person Email
csaura@vhio.net

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
LOXO-783

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