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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00486720
First received: June 14, 2007
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Myelodysplastic Syndromes
Blood Disease
Bone Marrow Disease
Drug: vorinostat
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: June 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
vorinostat 400 mg
Drug: vorinostat
vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.
Other Names:
  • suberoylanilide hydroxamic acid (SAHA)
  • ZOLINZA®
Experimental: 2
vorinostat 200 mg
Drug: vorinostat
vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.
Other Names:
  • suberoylanilide hydroxamic acid (SAHA)
  • ZOLINZA®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486720

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00486720     History of Changes
Other Study ID Numbers: 0683-064, MK0683-064, 2007_536
Study First Received: June 14, 2007
Results First Received: April 19, 2010
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Preleukemia
Syndrome
Disease
Neoplasms
Pathologic Processes
Precancerous Conditions
Vorinostat
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014