A Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

June 4, 2009

Primary Completion Date

March 25, 2011

Study Completion Date

March 20, 2012

Conditions
Cancer
Interventions
DRUG

GSK2118436

Dose escalation with GSK2118436 may proceed until either a maximum tolerated dose is established, or the toxicokinetic safety limit is reached.

DRUG

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.

DRUG

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.

Trial Locations (8)

2031

GSK Investigational Site, Randwick

2145

GSK Investigational Site, Westmead

5000

GSK Investigational Site, Adelaide

6009

GSK Investigational Site, Nedlands

10016

GSK Investigational Site, New York

37203

GSK Investigational Site, Nashville

77030

GSK Investigational Site, Houston

90025

GSK Investigational Site, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY