A Phase 1 interventional study of GSK2126458 and GSK1120212 in Cancer, sponsored by GlaxoSmithKline. Terminated at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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.
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.
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The first combination schedule that will be tested involves giving both GSK2126458 and GSK1120212 continuously once a day in the morning until the subjects withdraw from the study. Other dosing schedules with both drugs will also be tested and these schedules are described below GSK2126458 will be dosed twice per day (morning and evening) continuously and GSK1120212 will be dosed once a day in the morning on a continuous schedule. Subjects will be treated with both drugs and remain in the study as long as they are benefiting from therapy. Another schedule that will be tested involves giving GSK2126458 twice each day (morning and evening) on an intermittent schedule (4 days of treatment, 10 days rest, then 4 days treatment, 10 days rest). GSK1120212 will be dosed once each day in the morning on a continuous schedule. Subjects will be treated with both drugs as long as they are benefiting from therapy.
Drug: GSK2126458 and GSK1120212
GSK2126458 and GSK1120212 are experimental treatments for patients with cancer.
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.
Time frame: Subjects continue on study until disease progression or consent withdrawn.
To characterize the tolerability 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.
Time frame: Subjects continue on study until disease progression or consent withdrawn.
To determine the recommended Phase II regimen(s) of GSK2126458 and GSK1120212 dosed orally in combination based on safety, tolerability, PK and PD markers (e.g. changes from baseline in biomarkers of pathway inhibition).
Time frame: Subjects continue on study until disease progression or consent withdrawn.
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline