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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00486720
Phase
PHASE2
Status
Terminated

Conditions

  • Blood Disease
  • Bone Marrow Disease
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.
  • vorinostat — DRUG
    vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.

Study Details

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

Key Dates

Start date
Jun 30, 2007
Status verified
Jun 2015
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    vorinostat 400 mg
  • Experimental: 2
    vorinostat 200 mg

Primary Outcome Measure

Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria [ Time Frame: 2 Years ]

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