At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 37 enrolled
Drug / intervention
Quizartinibdrug
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.
Phase 2 Open-label, Single-arm Study of Quizartinib (AC220) Monotherapy in Japanese Patients With FLT3-ITD Positive Refractory or Relapsed Acute Myeloid Leukemia
In Brief
A Phase 2 clinical trial evaluating Quizartinib for Leukemia, Myeloid, Acute. Completed, enrolled 37 participants across 27 sites.
Detailed Summary
This is a Phase 2, multi-center, open-label study to evaluate the efficacy, safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive refractory or relapsed acute myeloid leukemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Acute
CountriesJapan
CollaboratorsDaiichi Sankyo
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartDec 2016
Primary CompletionMar 2018
Study CompletionSep 2018
TodayJul 2026
First PostedDec 7, 2016
Enrollment StartDec 8, 2016
Primary CompletionMar 28, 2018
Study CompletionSep 14, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.6 years ago
Interventions
Quizartinibdrug
Quizartinib was orally administered once daily every morning. Treatment with quizartinib was administered in 28-day cycles and continued until the discontinuation criteria for treatment were met.