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PSCI-18-052 A Phase II Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients with Advanced Biliary Tract Carcinoma who have Failed Prior Chemotherapy
The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in patients with late-stage or progressed BTC that has failed one line of chemotherapy.
The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in patients with late-stage or progressed BTC that has failed one line of chemotherapy.
Irina Geier - at igeier@pennstatehealth.psu.edu or 717-531-4300
All
18 year(s) or older
NCT04003896
STUDY00010946
Inclusion Criteria:
Histologic or cytologic evidence of advanced or metastatic biliary tract cancer including cholangiocarcinoma (intra-hepatic or extra-hepatic bile ducts), ampullary carcinoma, and gallbladder carcinoma.Evidence of recurrent, locally advanced, or metastatic disease.
Progressed following or intolerant to one or more line of systemic therapy.
Presence of at least 1 lesion that is measurable or evaluable using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Adequate organ function, as evidenced by the laboratory parameters noted in Study Eligibility.
Exclusion Criteria:
Ongoing or active infection requiring systemic antibiotics.History of previous venous thromboembolic events.
Uncontrolled hypertension despite adequate therapy (i.e., systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
Diabetes mellitus and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
Active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers with no known active disease in the 3 years prior to enrollment.
Cancer