Clinical trial NCT02773459 (phase 1/phase 2, status: completed)
Conditions: biliary tract cancer
ICD codes: C24.9, C24.8
Drugs: mek162+capecitabine
SMILES: CN1C=NC2=C(F)C(NC3=CC=C(Br)C=C3F)=C(C=C12)C(=O)NOCCO
Eligibility criteria:

        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