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Completed Phase 2 Interventional

Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA

ClinicalTrials.gov ID: NCT01993641

Public ClinicalTrials.gov record NCT01993641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 5:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Simon Two-Stage Study of the Addition of Pracinostat to a Hypomethylating Agent (HMA) in Patients With Myelodysplastic Syndrome (MDS) Who Have Failed to Respond or Maintain a Response to the HMA Alone

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this open label study is to determine whether combining pracinostat (study drug) with Vidaza (azacitidine) or Dacogen (decitabine) will improve clinical responses in Myelodysplastic Syndrome (MDS) patients who have failed an initial single agent hypomethylating agent (HMA), and to provide additional safety and efficacy data.

Study identification

NCT ID
NCT01993641
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Helsinn Healthcare SA
Industry
Enrollment
45 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2013 (Type not available)
Primary completion
May 2015 (Actual)
Completion
Jun 2016 (Actual)
Last update posted
Feb 23, 2017

2013 – 2016

United States locations

U.S. sites
21
U.S. states
13
U.S. cities
20
Facility City State ZIP Site status
Southern Cancer Center Mobile Alabama 36608 —
City of Hope Duarte California 91010 —
USC Norris Comprehensive Cancer Center Los Angeles California 90033 —
Sutter Medical Group Sacramento California 95816 —
Colorado Blood Cancer Institute Denver Colorado 80218 —
Yale School of Medicine New Haven Connecticut 06520 —
Florida Cancer Specialist South Fort Myers Florida 33916 —
Florida Cancer Specialist North St. Petersburg Florida 33705 —
Northwestern University Chicago Illinois 60601 —
University of Kansas Cancer Center Westwood Kansas 66205 —
University of Kentucky Lexington Kentucky 40536 —
John Theurer Cancer Center Hackensak New Jersey 07601 —
Oncology Hematology Care Cincinati Ohio 45242 —
Cleveland Clinic Cleveland Ohio 44195 —
University of Oklahoma Health Science Center Oklahoma City Oklahoma 73104 —
Tennessee Oncology-Chattanooga Chattanooga Tennessee 37404 —
Tennessee Oncology Nashville Tennessee 37203 —
Baylor University Medical Center Dallas Texas 75246 —
University of Texas Southwestern Dallas Texas 75390 —
MD Anderson Cancer Center Houston Texas 77030 —
Cancer Care Centers of South Texas San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01993641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 23, 2017 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01993641 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →