At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 72 enrolled
Drug / intervention
Azacitidinedrug
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.
A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Azacitidine in Adult Chinese Subjects With Higher-Risk Myelodysplastic Syndromes
In Brief
A Phase 2 clinical trial evaluating Azacitidine for Myelodysplastic Syndrome (MDS). Completed, enrolled 72 participants across 11 sites.
Detailed Summary
The purpose of the study is to determine whether azacitidine is safe and effective in the treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome (MDS)
CountriesChina
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartJul 2012
Primary CompletionJan 2015
Study CompletionMar 2018
TodayJul 2026
First PostedMay 16, 2012
Enrollment StartJul 24, 2012
Primary CompletionJan 29, 2015
Study CompletionMar 13, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.1 years ago
Interventions
Azacitidinedrug
Subcutaneous administration of azacitidine 75 mg/m\^2/day for 7 days every 28 days optimally for at least 6 cycles until disease progression, unacceptable toxicity, or treatment discontinuation for any other reason