At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 110 enrolled
Drug / intervention
Vorinostat +1 moredrug
Likely dose
Vorinostat 200 mgfrom 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 2 Trial of Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Who Are Ineligible for Other Leukemia Protocols
In Brief
A Phase 2 clinical trial evaluating Vorinostat and Azacitidine for Leukemia. Completed, enrolled 110 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if the combination of azacitidine and vorinostat can help to control AML or MDS better than azacitidine alone. The safety of this drug combination will also be studied.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, Celgene Corporation
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartSep 2009
Primary CompletionApr 2015
Study CompletionAug 2017
TodayJul 2026
First PostedJul 29, 2009
Enrollment StartSep 8, 2009
Primary CompletionApr 1, 2015
Study CompletionAug 3, 2017
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 16.9 years ago
Interventions
Vorinostatdrug
200 mg by mouth three (3) times per day with food for 5 days (Days 1 - 5)
Azacitidinedrug
75 mg/m\^2/day given intravenously over 15 - 30 minutes daily for 5 days (Days 1 - 5)