Safety Study of PLX108-01 in Patients With Solid Tumors

Safety Study of PLX108-01 in Patients With Solid Tumors

Solid Tumors

Ongoing, but not recruiting

1

Start Date 09/01/2009

Age of Trial (yrs) 15.2

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST plus other cancers

PLX108-01

Plexxikon

Oral

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. These tumors include, but are not limited to, acute myelogenous leukemia (Flt3), gastrointestinal stromal tumor and neurofibromatosis-1 (Kit), and glioma, breast cancer, prostate cancer, multiple myeloma, and osteosarcoma (Fms/CSF-1). The secondary objective is to measure the pharmacodynamic activity of PLX3397 via plasma and urine biomarkers of Fms activity.