Completed PHASE2 INTERVENTIONAL 1-arm NCT01993641

Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA (MEI-005)

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

Sponsor: Helsinn Healthcare SA

Conditions MDS Myelodysplastic Syndrome

Interventions Azacitidine Decitabine pracinostat

Updated 9 times since 2017 Last updated: Feb 22, 2017 Started: Dec 31, 2013 Primary completion: May 31, 2015 Completion: Jun 30, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates MDS and Myelodysplastic Syndrome and is currently completed. Helsinn Healthcare SA leads this study, which shows 9 recorded versions since 2013 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Apr 2022 — Jul 2024 [monthly]

Completed PHASE2
Jan 2021 — Apr 2022 [monthly]

Completed PHASE2

▶ Show 4 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE2
Mar 2017 — Jun 2018 [monthly]

Completed PHASE2
Feb 2017 — Mar 2017 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Dec 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Helsinn Healthcare SA

Data source: Helsinn Healthcare SA

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Chattanooga, United States , Chicago, United States , Cincinati, United States , Cleveland, United States , Dallas, United States , Denver, United States , Duarte, United States , Fort Myers, United States , Hackensak, United States , Houston, United States and 10 more locations