Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes (0683-064)
June 8, 2015 updated by: Merck Sharp & Dohme LLC
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).
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
vorinostat 400 mg
|
vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.).
Treatment in 21 day cycles for up to 8 cycles.
Other Names:
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:
|
|
Experimental: 2
vorinostat 200 mg
|
vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.).
Treatment in 21 day cycles for up to 8 cycles.
Other Names:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria
Time Frame: 2 Years
|
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.
Time Frame: Every 21 days while on therapy and at 30 days after the last dose of study therapy
|
Every 21 days while on therapy and at 30 days after the last dose of study therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
June 14, 2007
First Submitted That Met QC Criteria
June 14, 2007
First Posted (Estimate)
June 15, 2007
Study Record Updates
Last Update Posted (Estimate)
July 3, 2015
Last Update Submitted That Met QC Criteria
June 8, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0683-064
- MK0683-064
- 2007_536
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.