Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes (0683-064)

Phase 2

Terminated

• Conditions: Blood Disease; Myelodysplastic Syndromes; Bone Marrow Disease
• Interventions: Drug: vorinostat

• Registration Number: NCT00486720
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-14
• Study First Submitted QC: 2007-06-14
• Study First Posted: 2007-06-15
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2010-04-19
• Results First Submitted QC: 2010-05-24
• Results First Posted: 2010-06-22
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Patient is a male or female, at least 18 years of age with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) defined by the International Prognostic Scoring System

• Patient has previously untreated disease, or has received up to one prior treatment regimen for lower-risk Myelodysplastic Syndrome
• Patient has a performance status of equal to or less than 2 on the Eastern Cooperative Oncology Group Performance Scale
• Patient must have adequate organ function

Exclusion Criteria

• Patient has clinical evidence of Central Nervous System (CNS) leukemia
• Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
• Patient had prior treatment with a histone deacetylase inhibitor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	vorinostat	vorinostat 200 mg
1	vorinostat	vorinostat 400 mg

Primary Outcome Measures

Name	Time	Method
Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria	2 Years	Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study.
Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.	Every 21 days while on therapy and at 30 days after the last dose of study therapy