Clinical trial • Phase I • Haematology
AG-120 for Acute myeloid leukemia (newly diagnosed) | IDH1-mutated acute myeloid leukemia | IDH2-mutated acute myeloid leukemia
Phase I trial of AG-120 for Acute myeloid leukemia (newly diagnosed) | IDH1-mutated acute myeloid leukemia | IDH2-mutated acute myeloid leukemia.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Acute myeloid leukemia (newly diagnosed) | IDH1-mutated acute myeloid leukemia | IDH2-mutated acute myeloid leukemia
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 05-09-2024
- First CTIS Authorization Date
- 23-09-2024
Trial design
Phase I trial across 1 site in Netherlands.
- Target Sample Size
- 114
Recruitment
- Planned Sample Size
- 114
- Recruitment Window Months
- 120
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 114
Netherlands
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 04-03-2025
- Processing Time Days
- 166
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Stichting Amsterdam UMC
- Department Name
- Hematology
- Contact Person Name
- Dave de Leeuw
- Contact Person Email
- hematology@amsterdamumc.nl
Sponsor
Primary sponsor
- Full Name
- Institut De Recherches Internationales Servier IRIS
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- AG-120
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- oral
- Investigational Product Name
- AG-221
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- oral
- Combination Treatment
- Yes
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