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.