At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 66 enrolled
Drug / intervention
Vosaroxin +1 moredrug
Likely dose
Vosaroxin 90 mg/m2from 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/II Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome
In Brief
A Phase 2 clinical trial evaluating Vosaroxin and Decitabine for Leukemia. Completed, enrolled 66 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if the combination of vosaroxin and decitabine can help to control AML or MDS. The safety of these drugs will also be studied.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsSunesis Pharmaceuticals
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartJul 2013
Primary CompletionJan 2021
TodayJul 2026
First PostedJul 9, 2013
Enrollment StartJul 18, 2013
Primary CompletionJan 11, 2021
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 13.0 years ago
Interventions
Vosaroxindrug
Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle. Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.
Decitabinedrug
Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).