MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer

Inclusion Criteria:

* Histologically / cytologically verified, non-resectable, recurrent, or metastatic biliary tract carcinoma including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma
* Patients who have previously treated with gemcitabine-based chemotherapy (Prior treatment regimen up to 2 is allowed)
* Patients must have measurable or evaluable disease by RECIST 1.1
* Eastern Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1
* Age ≥ 20 years
* Adequate bone marrow function defined as: Hb ≥ 8 g/dl, absolute neutrophil count (ANC) ≥ 1500/microliter (mcL), Platelets ≥ 100 x10\^3/mcL
* Adequate renal function defined as serum creatinine \< 1.6 mg/dl and/or measured creatinine clearance from 24-hour urine collection of ≥ 60 ml/min
* Adequate hepatic function defined as total bilirubin ≤ 2 mg/dl, alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN)
* Patients with biliary obstruction can join if bilirubin corrects to required limit after adequate biliary drainage
* Women of childbearing potential must have a negative pregnancy test within 7 days prior to study treatment
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Evidence of another active cancer that may influence patient outcome, except for nonmelanoma skin carcinoma, melanoma in-situ, in-situ carcinoma of the cervix curatively treated, treated superficial bladder cancer, and adenocarcinoma of the prostate that has been surgically treated with a post-treatment prostate surface antigen (PSA) that is non-detectable
* Known brain metastases or primary central nervous system tumors with seizures that are not well controlled with standard medical therapy
* Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements
* Known HIV positive patient
* Significant cardiovascular disease including congestive heart failure (New York Heart Association Class II or higher) or active angina pectoris
* Uncontrolled diabetes mellitus
* History of a myocardial infarction within 6 months
* History of a stroke or transient ischemic attack within 6 months
* Clinically significant peripheral vascular disease
* Major surgical procedure within 4 weeks
* Uncontrolled infection
* Known or suspected allergy to capecitabine
* Pregnant (positive pregnancy test)
* Breast-feeding should be discontinued if a nursing mother is to be treated on clinical trial
* Any condition that impairs patient's ability to swallow whole pills
* Malabsorption problem that may limit or inhibit the absorption of MEK162
* History of any organ or bone marrow transplant