drugset / Trial / NCT01828034

First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma

NCT01828034

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers. Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and gallbladder cancers. The investigators are looking to improve treatment results. They will attempt to do so by adding the drug MEK162 to the treatment plan. MEK162 acts by blocking a protein called MEK 1/2 which helps cancer cells grow and divide. This study will help answer the question of whether MEK162 is a helpful drug in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.

Timeline

Start
2013-04
Primary completion
2019-05-30
Completion
2019-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Binimetinib Small molecule 45 mg
Subject Cisplatin Other / unclassified 20 mg/m2
Subject Gemcitabine Small molecule 800 mg/m2
Subject Gemcitabine Small molecule 1000 mg/m2

Indications