At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 71 enrolled
Drug / intervention
vorinostat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Clinical Trial of Vorinostat in Combination With Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
In Brief
A Phase 1 clinical trial evaluating vorinostat and decitabine for Leukemia, Myelocytic, Acute Myelodysplastic Syndromes and Myelodysplastic Syndromes. Completed, enrolled 71 participants.
Detailed Summary
This study is to evaluate the safety and tolerability of vorinostat in combination with decitabine as well as the in vivo molecular and biological effects of vorinostat in patients with refractory or relapsed Acute Myelogenous Leukemia (AML) and intermediate or high risk as defined by International Prognostic Scoring System (IPSS) Myelodysplastic Syndrome (MDS). Participants with Acute Myelogenous Leukemia or Myelodysplastic Syndrome are eligible.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartJun 2007
Primary CompletionApr 2010
Study CompletionMar 2012
TodayJul 2026
First PostedMay 28, 2007
Enrollment StartJun 1, 2007
Primary CompletionApr 1, 2010
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.1 years ago
Interventions
vorinostatdrug
decitabinedrug