Addition of Vorinostat to Azacitidine in Higher Risk MDS a Phase II add-on Study in Patients With Azacitidine Failure
Status:
Terminated
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
Azacytidine (AZA) is the current standard of care for frontline patient treated with
high-risk MDS and is clinically active in all type of MDS, however, 50% of the patients will
never respond. Vorinostat is an orally available HDAC inhibitor with clinical activity in MDS
and proven in vitro synergy with AZA. Patient treated upfront with a combination of this
agents have shown more responses based on phase I/II data. In the present study, we will use
the combination of these two drugs to try to create a synergetic effect and generate a
response for patients who experienced treatment failure after AZA.
All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of 28
days. Study Design