A Phase I Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK2126458 and GSK1120212 Combination Therapy in Subjects With Advanced Solid Tumors.
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To characterize the safety of GSK2126458 and GSK1120212 dosed orally in combination through adverse event assessment and changes in safety assessments including laboratory parameters, vital signs, and ECG parameters.
Subjects continue on study until disease progression or consent withdrawn.
GSK Clinical Trials
Canada: Health Canada
|GSK Investigational Site||Raleigh, North Carolina 27609|
|GSK Investigational Site||Germantown, Tennessee 38138|