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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 Sep 1, 2026, 7:43 PM 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
Nov 30, 2013
Primary completion
Apr 30, 2015
Completion
May 31, 2016
Last update posted
Feb 22, 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 22, 2017 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01993641 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →