At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 130 enrolled
Drug / intervention
ASTX727 Dose Escalation +2 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 Phase1-2 Pharmacokinetic Guided Dose-Escalation and Dose-Confirmation Study of ASTX727, a Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 With Oral Decitabine in Subjects With Myelodysplastic Syndromes (MDS)
In Brief
A Phase 2 clinical trial evaluating ASTX727 Dose Escalation, ASTX727 Dose Confirmation, and 1 other intervention for Myelodysplastic Syndrome and MDS. Completed, enrolled 130 participants across 17 sites in 2 countries.
Detailed Summary
This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of ASTX727, as well as determined the dose for later stages.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome, MDS
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartOct 2014
Primary CompletionJun 2018
Study CompletionDec 2019
TodayJul 2026
First PostedApr 4, 2014
Enrollment StartOct 28, 2014
Primary CompletionJun 5, 2018
Study CompletionDec 4, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.2 years ago
Interventions
ASTX727 Dose Escalationdrug
Oral investigational product and approved IV decitabine
ASTX727 Dose Confirmationdrug
Randomization cross over design for courses 1 and 2
ASTX727 Fixed-Dose Combinationdrug
Fixed-dose investigational product