MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer

This is an interventional treatment trial for Biliary Tract Cancer Read More

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