Trial intelligence / Profile preview

ASTX030 (oral cedazuridine + azacitidine) versus subcutaneous azacitidine in MDS/CMML/AML

2024-515098-93-00Phase 3Authorised

Sponsor
Taiho Oncology
Start
May 2025
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, DNA Intercalators/Alkylators → Nucleic Acid-Directed Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules
Countries
10
01

Overview

Phase 3, randomised, open-label trial of cedazuridine + azacitidine in myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) (2 arms), sponsored by Taiho Oncology. Primary endpoint: azacitidine exposure AUC ratio. Planned start May 2025; status: authorised.

02

Drugs

cedazuridine + azacitidine
03

Conditions

myelodysplastic syndrome (MDS)chronic myelomonocytic leukemia (CMML)acute myeloid leukemia (AML)

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