NCT01873703

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

A Phase 2 Randomized Double-Blind Placebo-Controlled Study of Pracinostat in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate Risk-2 or High-Risk Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	pracinostat	Histone deacetylase inhibitor (HDACi)
DRUG	Placebo	Placebo
DRUG	Azacitidine	Active comparator 75 mg/m2 Azacitidine for 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous infusion if SC injections are intolerable

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-11-01
• Completion: 2016-11-01
• First posted: 2013-06-10
• Last updated: 2018-09-13

Locations

24 sites across 1 country: United States