Clinical trial • Phase I • Oncology

AMG 509 for Metastatic castration-resistant prostate cancer | Castration-resistant prostate cancer

Phase I trial of AMG 509 for Metastatic castration-resistant prostate cancer | Castration-resistant prostate cancer. 479 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic castration-resistant prostate cancer | Castration-resistant prostate cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
14-05-2024
First CTIS Authorization Date
31-05-2024

Trial design

Phase I trial across 14 sites in Germany, Portugal, Spain.

Target Sample Size
479

Recruitment

Planned Sample Size
479
Recruitment Window Months
61

Geography

Total Number Of Sites
14
Total Number Of Participants
61

Germany

Earliest CTIS Part Ii Submission Date
21-03-2024
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
600
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Urology
Contact Person Name
Sylvie Lorenzen
Contact Person Email
sylvie.lorenzen@mri.tum.de
Site Name
Universitaet Muenster
Department Name
Urology
Contact Person Name
Katrin Schlack
Contact Person Email
katrin.schlack@ukmuenster.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
NCT
Contact Person Name
Stefanie Zschaebitz
Site Name
Universitaetsklinikum Essen AöR
Department Name
Urology
Contact Person Name
Victor Gruenwald
Contact Person Email
victor.gruenwald@uk-essen.de

Portugal

Earliest CTIS Part Ii Submission Date
21-03-2024
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
597
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Contact Person Name
Alina Rosinha
Site Name
Hospital Da Luz S.A.
Department Name
Serviço de Oncologia
Contact Person Name
João Moreira Pinto
Site Name
START Lisbon, Hospital de Santa Maria, Centro Hospitalar Universitário de Lisboa Norte E.P.E.
Department Name
Serviço de Oncologia Médica
Contact Person Name
André Mansinho
Contact Person Email
andre.mansinho@startlisbon.com

Spain

Earliest CTIS Part Ii Submission Date
21-03-2024
Latest Decision Or Authorization Date
19-11-2025
Processing Time Days
598
Number Of Sites
7
Number Of Participants
35

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Oncologia Medica
Contact Person Name
Begoña Mellado Gonzalez
Contact Person Email
BMELLADO@clinic.cat
Site Name
Hospital Clinico San Carlos
Department Name
Servicio de Oncologia Medica
Contact Person Name
Javier Puente Vazquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Servicio de Oncologia Medica
Contact Person Name
Jose Luis Perez Gracia
Contact Person Email
jlgracia@unav.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncologia
Contact Person Name
Daniel Ernesto Castellano Gauna
Contact Person Email
cdanicas@hotmail.com
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Servicio de Oncologia Medica
Contact Person Name
Jose Luis Perez Gracia
Contact Person Email
jlgracia@unav.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncologia
Contact Person Name
Joaquín Mateo Valderrama
Contact Person Email
jmateo@vhio.net
Site Name
Clinica Universidad De Navarra (additional site)
Department Name
Servicio de Oncologia Medica
Contact Person Name
Jose Luis Perez Gracia
Contact Person Email
jlgracia@unav.es

Sponsor

Primary sponsor

Full Name
Amgen Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
AMG 509

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