Clinical trial • Phase III • Oncology

LY3484356 for Breast cancer|Endometrial cancer

Phase III trial of LY3484356 for Breast cancer|Endometrial cancer. 49 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer|Endometrial cancer
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
14-02-2024
First CTIS Authorization Date
26-04-2024

Trial design

Phase III trial across 12 sites in Spain, France, Belgium.

Target Sample Size
49

Recruitment

Planned Sample Size
49
Recruitment Window Months
21

Geography

Total Number Of Sites
12
Total Number Of Participants
12

Spain

Earliest CTIS Part Ii Submission Date
13-12-2023
Latest Decision Or Authorization Date
26-04-2024
Processing Time Days
135
Number Of Sites
6
Number Of Participants
7

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Elena Lopez Miranda
Principal Investigator Email
elemiranda@hotmail.com
Contact Person Name
Elena Lopez Miranda
Contact Person Email
elemiranda@hotmail.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Principal Investigator Name
Irene Moreno Candilejo
Principal Investigator Email
irene.moreno@startmadrid.com
Contact Person Name
Irene Moreno Candilejo
Contact Person Email
irene.moreno@startmadrid.com
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Principal Investigator Name
Jose Angel Garcia Saenz
Principal Investigator Email
jgsaenz@salud.madrid.org
Contact Person Name
Jose Angel Garcia Saenz
Contact Person Email
jgsaenz@salud.madrid.org
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Luis Manso Sanchez
Principal Investigator Email
luismansosanchez@gmail.com
Contact Person Name
Luis Manso Sanchez
Contact Person Email
luismansosanchez@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Haematological and Oncological diseases
Principal Investigator Name
Ivan Manuel Victoria Ruiz
Principal Investigator Email
ivictori@recerca.clinic.cat
Contact Person Name
Ivan Manuel Victoria Ruiz
Contact Person Email
ivictori@recerca.clinic.cat
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Joaquin Gavila Gregori
Principal Investigator Email
jgavila@fivo.org
Contact Person Name
Joaquin Gavila Gregori
Contact Person Email
jgavila@fivo.org

France

Earliest CTIS Part Ii Submission Date
13-12-2023
Latest Decision Or Authorization Date
02-05-2024
Processing Time Days
141
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie Médicale
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
Oncology medical Department
Principal Investigator Name
Jean-Yves Pierga
Principal Investigator Email
jean-yves.pierga@curie.fr
Contact Person Name
Jean-Yves Pierga
Contact Person Email
jean-yves.pierga@curie.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Principal Investigator Name
Lauriane EBERST
Principal Investigator Email
l.eberst@icans.eu
Contact Person Name
Lauriane EBERST
Contact Person Email
l.eberst@icans.eu

Belgium

Earliest CTIS Part Ii Submission Date
13-12-2023
Latest Decision Or Authorization Date
30-04-2024
Processing Time Days
139
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Institut Jules Bordet
Department Name
Clinical Trial Conduct Unit
Principal Investigator Name
Philippe Aftimos
Principal Investigator Email
philippe.aftimos@hubruxelles.be
Contact Person Name
Philippe Aftimos
Site Name
UZ Leuven
Department Name
Gynecologic Oncology
Principal Investigator Name
Patrick Neven
Principal Investigator Email
patrick.neven@uzleuven.be
Contact Person Name
Patrick Neven
Contact Person Email
patrick.neven@uzleuven.be
Site Name
Antwerp University Hospital
Department Name
Oncology
Principal Investigator Name
Hans Prenen
Principal Investigator Email
hans.prenen@uza.be
Contact Person Name
Hans Prenen
Contact Person Email
hans.prenen@uza.be

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
LY3484356

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