At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 132 enrolled
Drug / intervention
PLX3397drug
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 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX3397 in Patients With Advanced, Incurable, Solid Tumors in Which the Target Kinases Are Linked to Disease Pathophysiology
In Brief
A Phase 1 clinical trial evaluating PLX3397 for Solid Tumor. Completed, enrolled 132 participants across 13 sites.
Detailed Summary
PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesUnited States
CollaboratorsPlexxikon
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedOct 2009
Primary CompletionJan 2018
Study CompletionOct 2018
TodayJul 2026
First PostedOct 30, 2009
Enrollment StartOct 1, 2009
Primary CompletionJan 31, 2018
Study CompletionOct 25, 2018
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 16.7 years ago
Interventions
PLX3397drug
Capsules administered once or twice daily, continuous dosing