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