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

June 14, 2007
November 14, 2013
June 2007
July 2009   (final data collection date for primary outcome measure)
  • 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 ]
Efficacy of vorinostat in this patient population.
Complete list of historical versions of study NCT00486720 on ClinicalTrials.gov Archive Site
Not Provided
Safety and tolerability of vorinostat in this patient population.
Not Provided
Not Provided
 
Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes (0683-064)
A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myelodysplastic Syndromes
  • Blood Disease
  • Bone Marrow Disease
  • 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®
  • 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®
  • Experimental: 1
    vorinostat 400 mg
    Intervention: Drug: vorinostat
  • Experimental: 2
    vorinostat 200 mg
    Intervention: Drug: vorinostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00486720
0683-064, MK0683-064, 2007_536
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP