Clinical trial • Phase I • Oncology
JNJ-87189401 for Advanced prostate cancer | Prostate cancer | Metastatic prostate cancer | Hormone-refractory prostate cancer
Phase I trial of JNJ-87189401 for Advanced prostate cancer | Prostate cancer | Metastatic prostate cancer | Hormone-refractory prostate cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced prostate cancer | Prostate cancer | Metastatic prostate cancer | Hormone-refractory prostate cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 13-10-2023
- First CTIS Authorization Date
- 10-06-2024
Trial design
Phase I trial across 4 sites in Netherlands, France.
- Target Sample Size
- 98
Eligibility
Recruits 98 No vulnerable populations selected; trial includes adult male participants only; no assent or special consent handling specified..
- Vulnerable Population
- No vulnerable populations selected; trial includes adult male participants only; no assent or special consent handling specified.
Recruitment
- Planned Sample Size
- 98
- Recruitment Window Months
- 38
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 71
Netherlands
- Earliest CTIS Part Ii Submission Date
- 26-01-2024
- Latest Decision Or Authorization Date
- 23-02-2024
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 16
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Oncology
- Contact Person Name
- Debbie Robbrecht
- Contact Person Email
- d.robbrecht@erasmusmc.nl
France
- Earliest CTIS Part Ii Submission Date
- 08-02-2024
- Latest Decision Or Authorization Date
- 27-01-2026
- Processing Time Days
- 719
- Number Of Sites
- 3
- Number Of Participants
- 55
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncology
- Contact Person Name
- Christophe Massard
- Contact Person Email
- christophe.massard@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Contact Person Name
- Armelle Vinceneux
- Contact Person Email
- armelle.vinceneux@lyon.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Contact Person Name
- Diego Teyssonneau
- Contact Person Email
- d.teyssonneau@bordeaux.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- JNJ-87189401
- Investigational Product Name
- JNJ-78278343
- Combination Treatment
- Yes
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