drugset / Trial / NCT01352273

MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations

NCT01352273

Phase 1 Completed 69 enrolled Array BioPharma
NaSingle-groupOpen-labelTreatment

Summary

This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion part to further assess the safety and preliminary anti-tumor efficacy of this oral combination within two separate patient populations: i) patients with advanced solid tumors harboring BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS mutations.

Timeline

Start
2011-06
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Binimetinib Small molecule Oral
Subject RAF265 Small molecule Oral

Indications