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

NCT01873703 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2018-09-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Helsinn Healthcare SA

    lead INDUSTRY

Principal Investigators

  • Guillermo Garcia-Manero, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01873703 on ClinicalTrials.gov