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Oral azacitidine (ONUREG) vs placebo in low- or intermediate-risk myelodysplastic syndrome
jRCT2071220092Phase 3Active, not recruiting
- Sponsor
- Bristol Myers Squibb
- Start
- Apr 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
01
Overview
Phase 3, randomised, double-blind trial in myelodysplastic syndrome (MDS) comparing Phase 2 oral azacitidine fixed dose, Phase 3 Arm A: oral azacitidine plus best supportive care and Phase 3 Arm B: placebo plus best supportive care (3 arms). Primary endpoints: Number of participants with adverse events in Phase 2 and Complete remission within 6 cycles (Phase 2/3). Started Apr 2023; status: active, not recruiting.
02
Drugs
azacitidine
03
Conditions
myelodysplastic syndrome (MDS)
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