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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT02105350
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02105350
Study Brief:
Protocol Section:
NCT02105350