An Open-label Three Part Phase I/II Study to Investigate the Safety Pharamcokinetics Pharmacodynamics and Clinical Activity of the MEK Inhibitor GSK 1120212 BRAF Inhhibitor GSK 2118436 and the anti-EGFR Antibody Panitumumab in Combination with Subjects with BRAF-mutation V600E or V600K Positive Colorectal Cancer
This is an open-label, four-part Phase 1/2 study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of trametinib (GSK1120212) and dabrafenib (GSK2118436) when administered in combination with the anti-EGFR antibody panitumumab in subjects with BRAF-mutation V600E positive colorectal cancer (CRC) and in subjects with CRC With secondary resistance to prior anti-EGFR therapy. Part 1 of the study will consist of dose-escalation cohorts, following a 3 + 3 enrollment scheme. Part 2 of the study will consist of expansion cohorts to to investigate safety and clinical activity of dabrafenib in combination with panitumumab and trametinib plus dabrafenib in combination with panitumumab. Part 3 of the study will be a randomized Phase II study comparing dosing with dabrafenib in combination with panitumumab and trametinib plus dabrafenib in combination with panitumumab as compared to the chemotherapy comparator (a regimen of FOLFOX, FOLFIRI or irinotecan with or without panitumumab or bevacizumab). Part 4 of the study will investigate the trametinib/panitumumab combination, including dose escalation and subsequent cohort expansion in two patient populations: 1) BRAFmutation V600E positive CRC and 2) subjects with CRC who developed secondary resistance to prior anti-EGFR therapy.Subjects will be assigned to treatment groups in a randomized fashion to compare safety and clinical activity.
- Study Identifier: 817133
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