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

NCT01828034 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-11-17

Study results available
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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

DRUG

Gemcitabine

DRUG

Cisplatin

DRUG

MEK162

Sponsors & Collaborators

Principal Investigators

  • Ghassan Abou-Alfa, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01828034 on ClinicalTrials.gov