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

PHASE2CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2016

Conditions
Myelodysplastic Syndrome
Interventions
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

Trial Locations (24)

10065

Weill Cornell Medical Center, New York

20817

Center for Cancer and Blood Disorders, Bethesda

21287

Sidney Kimmel Comprehensive Cancer at Johns Hopkins, Baltimore

32308

Florida Cancer Specialist and Research Institute, Tallahassee

32503

Woodlands Medical Specialists, Pensacola

33612

H. Lee Moffitt Cancer Center, Tampa

33705

Florida Cancer Specialists North, St. Petersburg

33916

Florida Cancer Specialists South, Fort Myers

36608

Southern Cancer Center, Mobile

37203

Sarah Cannon Cancer Center, Tennessee Oncology, Nashville

37404

Tennessee Oncology - Chattanooga, Chattanooga

44195

Cleveland Clinic Foundation, Cleveland

45242

Oncology Hematology Care, Cincinnati

46202

Indiana University Simon Cancer Ctr, Indianapolis

46804

Fort Wayne Medical Oncology and Hematology, Fort Wayne

48202

Henry Ford Hospital, Detroit

48910

Michigan State University, Lansing

68114

Nebraska Methodist, Omaha

77030

MD Anderson Cancer Center, Houston

78229

Cancer Care Centers of South Texas, San Antonio

80218

Colorado Blood Cancer Institute, Denver

89148

Comprehensive Cancer Centers of Nevada, Las Vegas

92037

Scripps Cancer Center, La Jolla

98104

Swedish Cancer Institute, Seattle

Sponsors
All Listed Sponsors
lead

Helsinn Healthcare SA

INDUSTRY