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

Phase 2TerminatedNCT00486720

Merck Sharp & Dohme LLC22 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndromes Blood Disease Bone Marrow Disease

Interventions

vorinostatDRUG

vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.

vorinostatDRUG

vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria

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.

Time frame: 2 Years

Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.

Time frame: Every 21 days while on therapy and at 30 days after the last dose of study therapy

Data from ClinicalTrials.gov

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