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Phase 3 study of guadecitabine vs low‑dose cytarabine in untreated AML unfit for intensive chemotherapy

jRCT2080223017Phase 3Completed

Sponsor
Otsuka Pharmaceutical Co., Ltd.
Start
Nov 2015
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
01

Overview

Phase 3, randomised, open-label trial of guadecitabine in acute myeloid leukemia (AML) (2 arms), sponsored by Otsuka Pharmaceutical Co., Ltd. Primary endpoints: Complete remission rate and Overall survival. Started Nov 2015; status: completed.

02

Drugs

guadecitabine
03

Conditions

acute myeloid leukemia (AML)

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