drugset / Trial / NCT01873703

Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome

NCT01873703

Phase 2 Completed 102 enrolled Helsinn Healthcare SA
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this randomized, double-blind, placebo-controlled study is to determine the safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and FDA approved treatment for Myelodysplastic Syndrome (MDS).

Timeline

Start
2013-06
Primary completion
2015-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Pracinostat Other / unclassified 60 mg Oral
Background Azacitidine Other / unclassified 75 mg/m2 Subcutaneous