At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
Azacitidine +1 moredrug
Likely dose
Azacitidine 75 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.
Phase I/II Study of Sorafenib and 5-Azacitidine for the Treatment of Patients With Refractory or Relapsed Acute Leukemia and Myelodysplastic Syndrome (MDS) - (VZ-MDS-PI-0227)
In Brief
A Phase 2 clinical trial evaluating Azacitidine and Sorafenib for Leukemia. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can control the disease in patients with AML or MDS. The safety of this drug combination will also be studied.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsBayer, Onyx Therapeutics, Inc., Celgene
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartJan 2011
Primary CompletionMar 2015
TodayJul 2026
First PostedDec 7, 2010
Enrollment StartJan 1, 2011
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.6 years ago
Interventions
Azacitidinedrug
75 mg/m\^2 subcutaneously (SQ) or by vein (IV) daily for 7 days per 28 day cycle.
Sorafenibdrug
Starting dose level 200 mg by mouth two times a day in a 28 day cycle. In Phase II, Sorafenib administered per MTD dose from Phase I. Drug doses separated by approximately 12 hours.