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

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

Official Title
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A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

Conditions
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Myelodysplastic Syndromes, Blood Disease, Bone Marrow Disease

Intervention / Treatment
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* Drug: vorinostat
* Drug: vorinostat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>vorinostat 400 mg | Drug: vorinostat<br>* vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.<br>* Other names: ZOLINZA®;|
| Experimental: 2<br>vorinostat 200 mg | Drug: vorinostat<br>* vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.<br>* Other names: ZOLINZA®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 Years | 
| 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 |