NCT01828034

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

A Phase I/II Study of First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Biliary Tract Carcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine
DRUG	Cisplatin
DRUG	MEK162

Timeline

• Start date: 2013-04-01
• Primary completion: 2019-05-30
• Completion: 2019-05-30
• First posted: 2013-04-10
• Last updated: 2020-11-17
• Results posted: 2020-11-17

Locations

1 site across 1 country: United States