Study of a Focal Adhesion Kinase Inhibitor in Subjects With Solid Tumors
Status:
Completed
Trial end date:
2015-12-21
Target enrollment:
Participant gender:
Summary
This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will
identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following
identification of the MTD, enrollment into Parts 2, 3, 4 and 5 may be concurrent. Part 2 will
explore further the safety, PK, tolerability, and anti-tumor activity of GSK2256098 in
subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will
characterize the range of biologically effective doses by assessing pharmacodynamic (PD)
markers in hair, skin and tumor tissue at doses that will not go lower than 80 mg or above
the MTD dose levels tested during the Phase 1 dose escalation. Part 4 will explore further
the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed
glioblastoma multiforme (GBM). The primary objective of this study is to determine the
safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the
pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to
explore the anti-tumor activity of GSK2256098, and to explore relationships between
GSK2256098 PK, PD and clinical endpoints. Part 5 will investigate the time course, the extent
of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for
potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098
at Day 15 and later time points. The primary objective of this study is to determine the
safety, tolerability, and MTD of GSK2256098.