Clinical trial • Phase I • Oncology
JNJ-78278343 for Metastatic castration-resistant prostate cancer
Phase I trial of JNJ-78278343 for Metastatic castration-resistant prostate cancer. 91 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic castration-resistant prostate cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 21-11-2023
- First CTIS Authorization Date
- 11-01-2024
Trial design
Phase I trial across 7 sites in Netherlands, France, Spain.
- Target Sample Size
- 91
Recruitment
- Planned Sample Size
- 91
- Recruitment Window Months
- 67
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 103
Netherlands
- Earliest CTIS Part Ii Submission Date
- 08-12-2023
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 802
- Number Of Sites
- 1
- Number Of Participants
- 18
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical oncology
- Contact Person Name
- Debbie Robbrecht
- Contact Person Email
- interne.oncologie@erasmusmc.nl
France
- Earliest CTIS Part Ii Submission Date
- 08-12-2023
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 804
- Number Of Sites
- 3
- Number Of Participants
- 50
Sites
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- Oncologie medicale
- Contact Person Name
- Jean-Laurent Deville
- Contact Person Email
- jean-laurent.deville@ap-hm.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie medicale
- Contact Person Name
- Armelle Vinceneux
- Contact Person Email
- Armelle.VINCENEUX@lyon.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Departement d'innovation therapeutique et d'essais precoces
- Contact Person Name
- Christophe Massard
- Contact Person Email
- christophe.massard@gustaveroussy.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 08-12-2023
- Latest Decision Or Authorization Date
- 18-02-2026
- Processing Time Days
- 803
- Number Of Sites
- 3
- Number Of Participants
- 35
Sites
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Phase I Clinical Trial Unit
- Contact Person Name
- Laura Medina
- Contact Person Email
- laura.medina@ibima.eu
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Medical Oncology
- Contact Person Name
- Emiliano Calvo
- Contact Person Email
- emiliano.calvo@startmadrid.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Contact Person Name
- Bernard Doger
- Contact Person Email
- bernard.doger@startmadrid.com
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- JNJ-78278343
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