170
Participants
Start Date
June 4, 2009
Primary Completion Date
March 25, 2011
Study Completion Date
March 20, 2012
GSK2118436
Dose escalation with GSK2118436 may proceed until either a maximum tolerated dose is established, or the toxicokinetic safety limit is reached.
GSK2118436
Part 2 will use the recommended Part 2 dose of GSK2118436 identified during Part 1 of the study. Biologically active doses will be identified by measurement of pharmacodynamic markers in tumor tissue and blood across a range of doses and these doses may be explored in Part 2.
Midazolam
Midazolam will be administered alone and with GSK2118436 in a sub-set of subjects in Part 2 to study the effect of GSK2118436 on CYP3A using midazolam as a probe.
GSK Investigational Site, Randwick
GSK Investigational Site, Westmead
GSK Investigational Site, Adelaide
GSK Investigational Site, Nedlands
GSK Investigational Site, New York
GSK Investigational Site, Nashville
GSK Investigational Site, Houston
GSK Investigational Site, Los Angeles
Lead Sponsor
GlaxoSmithKline
INDUSTRY