Clinical trial • Phase I • Oncology
Clinical trial in Advanced solid tumor
Phase I trial for Advanced solid tumor. None/Not specified-controlled. 105 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumor
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 22-08-2024
- First CTIS Authorization Date
- 05-02-2025
Trial design
None/Not specified-controlled Phase I trial across 3 sites in Belgium, Netherlands, France.
- Comparator
- None/Not specified
- Target Sample Size
- 105
Recruitment
- Planned Sample Size
- 105
- Recruitment Window Months
- 52
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 45
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-11-2024
- Latest Decision Or Authorization Date
- 21-08-2025
- Processing Time Days
- 282
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- UZ Leuven
- Department Name
- Medical oncology
- Principal Investigator Name
- Patrick Schöffski
- Principal Investigator Email
- patrick.schoffski@uzleuven.be
- Contact Person Name
- Patrick Schöffski
- Contact Person Email
- patrick.schoffski@uzleuven.be
- Number Of Participants
- 8
Netherlands
- Earliest CTIS Part Ii Submission Date
- 25-11-2024
- Latest Decision Or Authorization Date
- 22-08-2025
- Processing Time Days
- 270
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Clinical Research Unit, Department of Medical Oncology
- Principal Investigator Name
- Neeltje Steeghs
- Principal Investigator Email
- n.steeghs@nki.nl
- Contact Person Name
- Neeltje Steeghs
- Contact Person Email
- n.steeghs@nki.nl
- Number Of Participants
- 9
France
- Earliest CTIS Part Ii Submission Date
- 16-10-2024
- Latest Decision Or Authorization Date
- 21-08-2025
- Processing Time Days
- 309
- Number Of Sites
- 1
- Number Of Participants
- 28
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Cancérologie médicale
- Principal Investigator Name
- Jean-Yves BLAY
- Principal Investigator Email
- jean-yves.blay@unicancer.fr
- Contact Person Name
- Jean-Yves BLAY
- Contact Person Email
- jean-yves.blay@unicancer.fr
- Number Of Participants
- 28
Sponsor
Primary sponsor
- Full Name
- Daiichi Sankyo Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
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