drugset / Trial / NCT01928940

Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part)

NCT01928940

Phase 2 Completed 12 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelTreatment

Summary

This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600E/K mutation positive advanced solid tumors (Phase I part) and BRAF V600E/K mutation positive cutaneous melanoma (Phase II part).

Timeline

Start
2013-08-15
Primary completion
2014-09-18
Completion
2016-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabrafenib Small molecule 150 mg
Subject Trametinib Small molecule 2 mg

Indications