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Mocetinostat vs Azacitidine in Elderly AML/MDS
NCT00666497Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2008
- Primary completion
- Apr 2009
- Countries
- 3
- Sponsor
- Mirati Therapeutics
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules
- Drugs
- mocetinostat
- Conditions
- acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)
01
Overview
Phase 2, randomised, open-label trial of mocetinostat in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (3 arms), sponsored by Mirati Therapeutics. Primary endpoint: Overall Response Rate. Started Jun 2008; status: terminated.
02
Design
3 arms- Study design
- RandomizedOpen-label
Azacitidine
Azacitidine monotherapy
Mocetinostat
Mocetinostat monotherapy
Combination
Azacitidine + Mocetinostat
03
Endpoints
Primary
Overall Response Rate
Secondary
Duration of Response
Time to Progression
Progression-Free Survival
RBC Transfusion Independence
Hematologic Improvement
Quality of Life
Safety Profile
Pharmacokinetics
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