Clinical trial • Phase I • Oncology

AG-120 for Acute myeloid leukaemia | Advanced hematologic malignancies with IDH1 mutation

Phase I trial of AG-120 for Acute myeloid leukaemia | Advanced hematologic malignancies with IDH1 mutation. 164 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Acute myeloid leukaemia | Advanced hematologic malignancies with IDH1 mutation
Trial Stage
Phase I
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-07-2024
First CTIS Authorization Date
14-08-2024

Trial design

Phase I trial in France.

Biomarker Stratified
True, biomarker: IDH1 mutation; strata: not specified
Target Sample Size
164

Eligibility

Recruits 164 Vulnerable population selected; no details on consent or assent handling are provided in the record..

Vulnerable Population
Vulnerable population selected; no details on consent or assent handling are provided in the record.

Recruitment

Planned Sample Size
164
Recruitment Window Months
133

Geography

Total Number Of Sites
3
Total Number Of Participants
164

France

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
07-02-2025
Processing Time Days
200
Number Of Sites
3
Number Of Participants
72

Sites

Site Name
Hospices Civils De Lyon
Department Name
Service d'Hematologie
Contact Person Name
Mael HEIBLIG
Contact Person Email
mael.heiblig@chu-lyon.fr
Site Name
Institut Gustave Roussy
Department Name
Service SITEP
Contact Person Name
Stephane DE BOTTON
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'hematologie
Contact Person Name
Arnaud PIGNEUX
Contact Person Email
Arnaud.pigneux@chu-bordeaux.fr

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

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