A Phase I/II Study of Gemcitabine, Cisplatin, and MEK162 as Initial Treatment for Advanced Bile Duct or Gallbladder Cancer

Protocol
13-004
Full Title
A Phase I/II Study of First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma
Phase
I/II
Purpose

Gemcitabine and cisplatin are two drugs commonly used to treat biliary cancers (those of the bile duct and gallbladder), but despite this approach, many patients succumb to these illnesses. Researchers want to determine if adding an investigational drug called MEK162 to treatment with gemcitabine and cisplatin improves the effectiveness of therapy.

MEK162 works by inhibiting a protein called MEK1/2, which can fuel cancer cell growth. It is taken orally (by mouth). In this study, investigators want to determine the highest dose of MEK162 that can be given safely as initial therapy in patients with advanced bile duct and gallbladder cancers, and observe its preliminary effectiveness against these cancers.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or metastatic cancer of the bile duct or gallbladder.
  • Patients may have had local therapy (such as radiation therapy or embolization), but may not have previously received chemotherapy or other systemic drugs. At least 4 weeks must have passed since completion of prior local therapy and entry into the study.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Maeve Lowery at 646-888-4543.

Disease(s)
Hepatobiliary
Upper Gastrointestinal
Locations