Clinical trial • Phase I • Oncology
ASP2138 for Gastroesophageal junction adenocarcinoma | Gastric adenocarcinoma | Pancreatic adenocarcinoma
Phase I trial of ASP2138 for Gastroesophageal junction adenocarcinoma | Gastric adenocarcinoma | Pancreatic adenocarcinoma. 278 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Gastroesophageal junction adenocarcinoma | Gastric adenocarcinoma | Pancreatic adenocarcinoma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 07-08-2023
- First CTIS Authorization Date
- 25-01-2024
Trial design
Phase I trial across 19 sites in France, Spain, Italy.
- Target Sample Size
- 278
- Trial Duration For Participant
- 1051
Eligibility
Recruits 278 Vulnerable population not selected (isVulnerablePopulationSelected=false); trial population described as adults in public title; no information provided on consent/assent handling in the record..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false); trial population described as adults in public title; no information provided on consent/assent handling in the record.
Recruitment
- Planned Sample Size
- 278
- Recruitment Window Months
- 34
- Consent Approach
- Trial population described as adults only; no specific information in the record about informed consent/assent process, age-specific documents, or languages available.
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 100
France
- Earliest CTIS Part Ii Submission Date
- 27-10-2023
- Latest Decision Or Authorization Date
- 27-01-2026
- Processing Time Days
- 823
- Number Of Sites
- 6
- Number Of Participants
- 43
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology/Phase 1 Depertment
- Principal Investigator Name
- Antoine Hollebecque
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
- Site Name
- Institut Paoli-Calmettes
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jean-Emmanuel Mitry
- Principal Investigator Email
- Mitryje@ipc.unicancer.fr
- Contact Person Name
- Jean-Emmanuel Mitry
- Contact Person Email
- Mitryje@ipc.unicancer.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Clinical Research Unit
- Principal Investigator Name
- Iphigénie Korakis
- Principal Investigator Email
- Korakis.iphigenie@iuct-oncopole.fr
- Contact Person Name
- Iphigénie Korakis
- Contact Person Email
- Korakis.iphigenie@iuct-oncopole.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Philippe Cassier
- Principal Investigator Email
- Philippe.cassier@lyon.unicancer.fr
- Contact Person Name
- Philippe Cassier
- Contact Person Email
- Philippe.cassier@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Gastro-Enterology and Medical Oncology
- Principal Investigator Name
- David Tougeron
- Principal Investigator Email
- David.TOUGERON@chu-poitiers.fr
- Contact Person Name
- David Tougeron
- Contact Person Email
- David.TOUGERON@chu-poitiers.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sandrine Hiret
- Principal Investigator Email
- Sandrine.hiret@ico.unicancer.fr
- Contact Person Name
- Sandrine Hiret
- Contact Person Email
- Sandrine.hiret@ico.unicancer.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 21-03-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 308
- Number Of Sites
- 8
- Number Of Participants
- 26
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Medical Oncology service
- Principal Investigator Name
- Paula Cerdà Serdà
- Principal Investigator Email
- PCerda@santpau.cat
- Contact Person Name
- Paula Cerdà Serdà
- Contact Person Email
- PCerda@santpau.cat
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Medical Oncology service
- Principal Investigator Name
- Roberto Antonio Pazo Cid
- Principal Investigator Email
- rpazo@salud.aragon.es
- Contact Person Name
- Roberto Antonio Pazo Cid
- Contact Person Email
- rpazo@salud.aragon.es
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Medical Oncology service
- Principal Investigator Name
- Tatiana Hernández Guerrero
- Principal Investigator Email
- tatiana.hernandez@start-barcelona.com
- Contact Person Name
- Tatiana Hernández Guerrero
- Contact Person Email
- tatiana.hernandez@start-barcelona.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Medical Oncology service
- Principal Investigator Name
- Miguel Marin Vera
- Principal Investigator Email
- miguelmarin75@hotmail.com
- Contact Person Name
- Miguel Marin Vera
- Contact Person Email
- miguelmarin75@hotmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology service
- Principal Investigator Name
- Mariona Calvo Campos
- Principal Investigator Email
- mcalvo@iconcologia.net
- Contact Person Name
- Mariona Calvo Campos
- Contact Person Email
- mcalvo@iconcologia.net
- Site Name
- Hospital General Universitario De Elche
- Department Name
- Medical Oncology service
- Principal Investigator Name
- Javier Gallego Plazas
- Principal Investigator Email
- j.gallegoplazas@gmail.com
- Contact Person Name
- Javier Gallego Plazas
- Contact Person Email
- j.gallegoplazas@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology service
- Principal Investigator Name
- Daniel Alejandro Acosta Eyzaguirre
- Principal Investigator Email
- dacosta@vhio.net
- Contact Person Name
- Daniel Alejandro Acosta Eyzaguirre
- Contact Person Email
- dacosta@vhio.net
- Site Name
- Institut Catala D'oncologia (duplicate listing consolidated)
- Department Name
- Medical Oncology service
Italy
- Earliest CTIS Part Ii Submission Date
- 09-11-2023
- Latest Decision Or Authorization Date
- 20-01-2026
- Processing Time Days
- 803
- Number Of Sites
- 5
- Number Of Participants
- 31
Sites
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Division of Early Drug Development
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- Humanitas Research Hospital
- Department Name
- Department of Oncology and Hematology-Oncology
- Principal Investigator Name
- Matteo Simonelli
- Principal Investigator Email
- matteo.simonelli@cancercentre.humanitas.it
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@cancercentre.humanitas.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Department of Oncology and Hematology-Oncology
- Principal Investigator Name
- Salvatore Siena
- Principal Investigator Email
- salvatore.siena@ospedaleniguarda.it
- Contact Person Name
- Salvatore Siena
- Contact Person Email
- salvatore.siena@ospedaleniguarda.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- UOC Oncology 1
- Principal Investigator Name
- Francesca Bergamo
- Principal Investigator Email
- francesca.bergamo@iov.veneto.it
- Contact Person Name
- Francesca Bergamo
- Contact Person Email
- francesca.bergamo@iov.veneto.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- UOC Oncologia
- Principal Investigator Name
- Michele Milella
- Principal Investigator Email
- michele.milella@univr.it
- Contact Person Name
- Michele Milella
- Contact Person Email
- michele.milella@univr.it
Sponsor
Primary sponsor
- Full Name
- Astellas Pharma Global Development Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- ASP2138
- Combination Treatment
- Yes
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