At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 90 enrolled
Drug / intervention
PLX3397 +1 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 Phase 1/2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory FLT3-ITD Positive Acute Myeloid Leukemia (AML)
In Brief
A Phase 2 clinical trial evaluating PLX3397 for Acute Myeloid Leukemia. Completed, enrolled 90 participants across 9 sites.
Detailed Summary
The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be considered based on safety and efficacy observations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesUnited States
CollaboratorsPlexxikon
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartNov 2011
Primary CompletionJan 2015
Study CompletionJan 2018
TodayJul 2026
First PostedMay 6, 2011
Enrollment StartNov 21, 2011
Primary CompletionJan 20, 2015
Study CompletionJan 9, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.2 years ago
Interventions
PLX3397drug
Maximum Tolerated Dose of PLX3397 will be administered orally, twice daily.
PLX3397drug
The drug product is available in capsule form, to be taken orally.