Clinical trial • Phase I • Oncology|Gastroenterology|Immunology
Tolinapant (ASTX660) for Locally advanced rectal cancer
Phase I trial of Tolinapant (ASTX660) for Locally advanced rectal cancer. open-label. 78 participants.
Overview
- Trial Therapeutic Area
- Oncology|Gastroenterology|Immunology
- Trial Disease
- Locally advanced rectal cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 16-04-2024
- First CTIS Authorization Date
- 10-06-2024
Trial design
open-label Phase I trial across 2 sites in France.
- Open Label
- Yes
- Target Sample Size
- 78
Recruitment
- Planned Sample Size
- 78
- Recruitment Window Months
- 98
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 78
France
- Earliest CTIS Part Ii Submission Date
- 24-04-2024
- Latest Decision Or Authorization Date
- 10-06-2024
- Processing Time Days
- 47
- Number Of Sites
- 2
- Number Of Participants
- 78
Sites
- Site Name
- Centre Leon Berard
- Department Name
- ONCOLOGIE
- Contact Person Name
- Jessica SERRAND
- Contact Person Email
- jessica.serrand@lyon.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- ONCOLOGIE
- Contact Person Name
- Eric DEUTSCH
- Contact Person Email
- eric.deutsch@gustaveroussy.fr
Sponsor
Primary sponsor
- Full Name
- Institut Gustave Roussy
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Tolinapant (ASTX660)
- Combination Treatment
- Yes
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