A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer

Inclusion Criteria: * Histopathological or cytological diagnosis of non-resectable, recurrent or metastatic biliary tract (intra- or extra-hepatic) or gallbladder carcinoma. * Have measurable disease. * Not received prior systemic therapy for advanced biliary cancer. * Age 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. * Estimated life expectancy is greater than 3 months. * Have adequate hematological function. * Have adequate cardiac function. * All radiology studies performed within 4 weeks prior to the start of therapy. * No evidence of active uncontrolled infection. * Ability to understand and willing to sign a written informed consent document. * Ongoing prior toxicities related to previous treatments received to grade 1 or less at time of registration. * Able to take oral medications. Exclusion Criteria: * Progressing within 6 months of receiving adjuvant treatment for biliary tract cancer. * Not have received prior chemotherapy for non-resectable or metastatic disease or MEK inhibitor. * Histopathological or cytological diagnosis of ampullary carcinoma. * Incomplete recovery from previous surgery. * Undergoing current treatment with curative intent. * History of prior malignancy that could interfere with the response evaluation. * Any evidence of severe or uncontrolled systemic diseases or laboratory findings that may affect participation in the trial. * Any psychiatric or other disorder likely to impact on informed consent. * Pregnant or nursing (lactating) women. * Agree to use highly effective methods of contraception throughout the study and for 6 months after study drug discontinuation. * Significant cardiac disease. * History of retinal degenerative disease. * History of Gilbert's syndrome. * Known positive serology for HIV, active hepatitis B, and/or active hepatitis C infection. * Neuromuscular disorders that are associated with elevated creatine kinase. * Planning on embarking on a new strenuous exercise regimen after first dose of study treatment. * Impairment of gastrointestinal function or gastrointestinal disease. * Any other condition that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures.