Trials / Completed
CompletedNCT01004861
Safety Study of PLX108-01 in Patients With Solid Tumors
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PLX3397 | Capsules administered once or twice daily, continuous dosing |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2018-01-31
- Completion
- 2018-10-25
- First posted
- 2009-10-30
- Last updated
- 2022-01-04
- Results posted
- 2020-04-06
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01004861. Inclusion in this directory is not an endorsement.