At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Quizartinibdrug
Likely dose
Quizartinib 30 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.
An Open-label, Single-dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Quizartinib in Subjects With Moderate Impaired Hepatic Function as Defined by NCI-ODWG Criteria
In Brief
A Phase 1 clinical trial evaluating Quizartinib for Hepatic Impairment and Moderate Impaired Hepatic Function. Completed, enrolled 12 participants across 3 sites.
Detailed Summary
Quizartinib is a novel oral Class III receptor tyrosine kinase (RTK) inhibitor exhibiting highly potent and selective but reversible inhibition of Feline McDonough sarcoma (FMS)-like tyrosine kinase 3 (FLT3). Quizartinib is currently being studied alone or in combination with other agents as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in adult and pediatric populations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartSep 2020
Primary CompletionJul 2021
TodayJul 2026
First PostedJul 16, 2020
Enrollment StartSep 22, 2020
Primary CompletionJul 22, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.0 years ago
Interventions
Quizartinibdrug
Single oral dose, 30 mg tablet