MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer

Phase 1/2 Completed 31 enrolled Seoul National University Hospital

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is to test the efficacy of MEK162 plus capecitabine in gemcitabine-pretreated advanced biliary tract cancer, and to explore the predictive biomarkers for future large-scale clinical trials using this combination.

Timeline

Start: 2016-04
Primary completion: 2019-01-07
Completion: 2019-01-07

Publications

Kim JW, Lee KH, Kim JW, Suh KJ, Nam AR, Bang JH, Bang YJ, Oh DY. Enhanced antitumor effect of binimetinib in combination with capecitabine for biliary tract cancer patients with mutations in the RAS/RAF/MEK/ERK pathway: phase Ib study. Br J Cancer. 2019 Aug;121(4):332-339. doi: 10.1038/s41416-019-0523-5. Epub 2019 Jul 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Binimetinib	Small molecule	15 mg	Oral
Subject	Binimetinib	Small molecule	30 mg	Oral
Subject	Capecitabine	Small molecule	1000 mg/m2	—
Subject	Capecitabine	Small molecule	1250 mg/m2	—

MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer

Summary

Timeline

Publications

Drugs

Indications