Clinical trial • Phase III • Oncology
AMG 193 for Gastrointestinal cancer | Biliary tract cancer | Pancreatic ductal adenocarcinoma with homozygous MTAP deletion
Phase III trial of AMG 193 for Gastrointestinal cancer | Biliary tract cancer | Pancreatic ductal adenocarcinoma with homozygous MTAP deletion.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Gastrointestinal cancer | Biliary tract cancer | Pancreatic ductal adenocarcinoma with homozygous MTAP deletion
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 07-05-2024
- First CTIS Authorization Date
- 28-08-2024
Trial design
Phase III trial across 24 sites in Netherlands, Denmark, Spain and others.
- Biomarker Stratified
- True, biomarker: homozygous MTAP deletion
- Target Sample Size
- 65
Eligibility
Recruits 65 Vulnerable population not selected; no special consent/assent handling specified..
- Vulnerable Population
- Vulnerable population not selected; no special consent/assent handling specified.
Recruitment
- Planned Sample Size
- 65
- Recruitment Window Months
- 63
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 81
Netherlands
- Earliest CTIS Part Ii Submission Date
- 22-08-2024
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 438
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Stichting Radboud universitair medisch centrum
- Department Name
- Medical Oncology
- Contact Person Name
- Ingrid Desar
- Contact Person Email
- ingrid.desar@radboudumc.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Medical Oncology
- Contact Person Name
- Hanneke Wilmink
- Contact Person Email
- j.w.wilmink@amsterdamumc.nl
Denmark
- Earliest CTIS Part Ii Submission Date
- 22-08-2024
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 438
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Department of Oncology
- Contact Person Name
- Rikke Loevendahl Eefsen
- Contact Person Email
- rikke.helene.loevendahl.eefsen@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 05-11-2025
- Processing Time Days
- 502
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Servicio de Oncologia Medica
- Contact Person Name
- Andres Muñoz Martin
- Contact Person Email
- andresmunmar@hotmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Servicio de Oncologia Medica
- Contact Person Name
- Manuel Jesus Valladares Ayerbes
- Contact Person Email
- manuelj.valladares.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncologia
- Contact Person Name
- Jaume Capdevila Castillon
- Contact Person Email
- jcapdevila@vhio.net
Greece
- Earliest CTIS Part Ii Submission Date
- 06-06-2024
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 516
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Oncology Department / Department of Clinical Therapeutics
- Contact Person Name
- Michalis Liontos
- Contact Person Email
- mliontos@gmail.com
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- Molecular Medicine Clinic/Clinical Trial Unit
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
- Site Name
- St. Luke's Hospital S.A.
- Department Name
- Oncology Department
- Contact Person Name
- Ippokratis Korantzis
- Contact Person Email
- ippokratis.korantzis@gmail.com
- Site Name
- Athens Medical Center S.A.
- Department Name
- 4th Department of Medical Oncology
- Contact Person Name
- Ippokratis Korantzis
- Contact Person Email
- ippokratis.korantzis@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 09-08-2024
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 452
- Number Of Sites
- 3
- Number Of Participants
- 19
Sites
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Comprehensive Cancer Center – Mainfranken
- Contact Person Name
- Maria-Elisabeth Goebeler
- Contact Person Email
- isz_koordination@ukw.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Nationales Centrum fuer Tumorerkrankungen
- Contact Person Name
- Christoph Springfeld
- Contact Person Email
- Studienteam-Phase1.NCT@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Innere Klinik - Tumorforschung
- Contact Person Name
- Stefan Kasper-Virchow
- Contact Person Email
- Stefan.Kasper-Virchow@uk-essen.de
France
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 19-11-2025
- Processing Time Days
- 475
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP Drug Development Department
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Contact Person Name
- Lola Jade Palmieri
- Contact Person Email
- l.palmieri@bordeaux.unicancer.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Outpatient Hospital
- Contact Person Name
- Brice Chanez
- Contact Person Email
- chanezb@ipc.unicancer.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology
- Contact Person Name
- François Ghiringhelli
- Contact Person Email
- fghiringhelli@cgfl.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 23-07-2024
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 513
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncologia Medica
- Contact Person Name
- Armando Santoro
- Contact Person Email
- armando.santoro@humanitas.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Oncologia Medica
- Contact Person Name
- Salvatore Siena
- Contact Person Email
- salvatore.siena@ospedaleniguarda.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Oncologia Medica
- Contact Person Name
- Michele Milella
- Contact Person Email
- michele.milella@aovr.veneto.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica
- Contact Person Name
- Filippo De Braud
- Contact Person Email
- debraud_studiclinici@istitutotumori.mi.it
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 529
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Oncology
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Oncology
- Contact Person Name
- Astrid De Cuyper
- Contact Person Email
- astrid.decuyper@saintluc.uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- Oncology
- Contact Person Name
- Jeroen Dekervel
- Contact Person Email
- jeroen.dekervel@uzleuven.be
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- AMG 193
- Combination Treatment
- Yes
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