Cancer Clinical Trial - Study to Investigate the Safety, Pharmacokinetics,

Status Terminated

Clinical Trial Summary

Clinical Trial Description

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 Part 1 dose escalation phase and a Part 2 tumor specific cohort expansion.

A continuous daily dosing schedule will be utilized initially for both investigational products. The frequency and schedule of dosing may be adjusted based on emerging safety, pharmacokinetics, and pharmacodynamics data.

Once a recommended regimen has been characterized in Part 1, it may be further evaluated in Part 2 . More than one regimen (doses and schedules) may be evaluated in Part 2, based on findings in Part 1.

Subjects eligible for enrollment in Part 2 will have solid tumors with genetic profiles that are likely to benefit from a MEK and PI3K pathway inhibition. ;

Study Design

Related Conditions & MeSH terms

Cancer

Clinical Trial Details

NCT number	NCT01248858
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Terminated
Phase	Phase 1
Start date	December 3, 2010
Completion date	April 23, 2015

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms