Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT02773459
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02773459
Study Brief:
Protocol Section:
NCT02773459