Clinical trial • Phase I • Oncology
Valemetostat for Metastatic castration-resistant prostate cancer (mCRPC)
Phase I trial of Valemetostat for Metastatic castration-resistant prostate cancer (mCRPC). 47 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic castration-resistant prostate cancer (mCRPC)
- Trial Stage
- Phase I
- Drug Modality
- Small molecule|Small molecule
Key dates
- Initial CTIS Submission Date
- 05-11-2025
- First CTIS Authorization Date
- 18-03-2026
Trial design
Phase I trial across 7 sites in Ireland, Spain, France.
- Target Sample Size
- 47
Recruitment
- Planned Sample Size
- 47
- Recruitment Window Months
- 50
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 13
Ireland
- Earliest CTIS Part Ii Submission Date
- 05-03-2026
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Austin Duffy
- Principal Investigator Email
- austin.duffy@startdublin.com
- Contact Person Name
- Austin Duffy
- Contact Person Email
- austin.duffy@startdublin.com
Spain
- Earliest CTIS Part Ii Submission Date
- 20-02-2026
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 27
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Bernard Gaston Doger de Spevile
- Principal Investigator Email
- bernard.doger@startmadrid.com
- Contact Person Name
- Bernard Gaston Doger de Spevile
- Contact Person Email
- bernard.doger@startmadrid.com
- Site Name
- Hospital San Pedro
- Department Name
- Oncology
- Principal Investigator Name
- Maria Jose de Miguel Luken
- Principal Investigator Email
- maria.demiguel@startrioja.com
- Contact Person Name
- Maria Jose de Miguel Luken
- Contact Person Email
- maria.demiguel@startrioja.com
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Fabricio Racca
- Principal Investigator Email
- fracca@nextoncology.eu
- Contact Person Name
- Fabricio Racca
- Contact Person Email
- fracca@nextoncology.eu
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Principal Investigator Name
- Valentina Boni
- Principal Investigator Email
- vboni@nextoncology.eu
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
France
- Earliest CTIS Part Ii Submission Date
- 20-02-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 73
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Centre Oscar Lambret
- Department Name
- Oncology
- Principal Investigator Name
- Karim FIZAZI
- Principal Investigator Email
- k-fizazi@o-lambret.fr
- Contact Person Name
- Karim FIZAZI
- Contact Person Email
- k-fizazi@o-lambret.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncology
- Principal Investigator Name
- Aude FLECHON
- Principal Investigator Email
- aude.flechon@lyon.unicancer.fr
- Contact Person Name
- Aude FLECHON
- Contact Person Email
- aude.flechon@lyon.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Daiichi Sankyo Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Valemetostat
- Active Substance
- Valemetostat
- Modality
- Small molecule
- Investigational Product Name
- Darolutamide
- Active Substance
- Darolutamide
- Modality
- Small molecule
- Combination Treatment
- Yes
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