drugset / Trial / NCT00439673

PhII 5-Azacytidine Plus Valproic Acid and Eventually Atra in Intermediate II and High Risk MDS

NCT00439673

Phase 2 Completed 62 enrolled GIMEMA Foundation
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective of the trial is to assess the activity of the combined use of Valproic Acid (VPA)in combination with 5-Azacytidine (5-Aza C) in the treatment of MDS. Activity will be evaluated as percentage of patients achieving complete or partial remission.

Timeline

Start
2007-05
Primary completion
2010-07
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified
Subject Tretinoin Small molecule
Subject Valproic Acid Small molecule