drugset / Trial / NCT01248858

Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK2126458 and GSK1120212 Combination Therapy in Subjects With Advanced Solid Tumors.

NCT01248858

Phase 1 Terminated 69 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase I, open-label, dose-escalation study to characterize the safety, tolerability, pharmacokinetic profile, pharmacodynamic profile, and clinical activity of the oral PI3K inhibitor GSK2126458 and the oral MEK inhibitor GSK1120212 dosed in combination in subjects with advanced solid tumors. The study will be conducted in 2 parts, a dose escalation phase and a tumor specific cohort expansion.

Timeline

Start
2010-12-03
Primary completion
2014-01-30
Completion
2015-04-23

Drugs

EvaluationDrugModalityDoseRoute
Subject OMIPALISIB Small molecule Oral
Subject Trametinib Small molecule Oral

Indications