Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes (0683-064)
|ClinicalTrials.gov Identifier: NCT00486720|
Recruitment Status : Terminated
First Posted : June 15, 2007
Results First Posted : June 22, 2010
Last Update Posted : July 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes Blood Disease Bone Marrow Disease||Drug: vorinostat||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome|
|Study Start Date :||June 2007|
|Primary Completion Date :||July 2009|
|Study Completion Date :||July 2009|
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.
vorinostat 200 mg
vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.
- 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486720
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|