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


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes, Blood Disease, Bone Marrow Disease

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2007_536

NCT ID:

NCT00486720

Start Date:

June 2007

Completion Date:

July 2009

Related Keywords:

  • Myelodysplastic Syndromes
  • Blood Disease
  • Bone Marrow Disease
  • Bone Marrow Diseases
  • Hematologic Diseases
  • Myelodysplastic Syndromes
  • Preleukemia

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