MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer

• Status: Completed
• Trial end date: 2019-01-07
• Target enrollment: 0
• Participant gender: All

Summary

This study is to test the efficacy of MEK162 plus capecitabine in gemcitabine-pretreated advanced biliary tract cancer, and to explore the predictive biomarkers for future large-scale clinical trials using this combination.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Capecitabine

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