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

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Vorinostat

Criteria

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