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
- Contact Person Email
- francois-clement.bidard@curie.fr
- 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
- Contact Person Email
- francois-clement.bidard@curie.fr
- 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
- Contact Person Email
- helene.vanacker@lyon.unicancer.fr
- 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
- Contact Person Email
- barbara.pistilli@gustaveroussy.fr
- 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
- Contact Person Email
- peter.fasching.studien@uk-erlangen.de
- 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
- Contact Person Email
- ulrich.lauer@med.uni-tuebingen.de
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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