Trial intelligence / Profile preview

Ivosidenib plus azacitidine safety study in newly diagnosed IDH1-mutant AML patients ineligible for intensive chemotherapy

NL-OMON59845Phase 3Active, not recruiting

Sponsor
Servier
Start
Sep 2023
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules
Countries
1
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Overview

Phase 3, open-label, single-arm trial of ivosidenib and azacitidine in acute myeloid leukemia (AML), sponsored by Servier. Primary endpoints: Adverse events, Clinical laboratory anomalies assessed as adverse events and 2 more. Started Sep 2023; status: active, not recruiting.

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Drugs

ivosidenibazacitidine
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Conditions

acute myeloid leukemia (AML)

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