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
Objective
Primary Objectives: To determine the objective response rate (ORR) Secondary Objectives: To determine progression free survival (PFS) To determine the disease control rate (DCR) To determine time to response (TTR) To determine time to progression (TTP) To determine time to new metastatic lesion(s) (TTNM) To determine the overall survival (OS) rate at 6 and 12 months To determine quality of life (QoL) using EORTC-QLQ-C30 (see Appendix C) To determine the efficacy and safety of abemaciclib with regard to the subtypes of biliary tract carcinoma (BTC) including intrahepatic cholangiocarcinoma (IHCC), extra-hepatic cholangiocarcinoma (EHCC), ampullary carcinoma, and gall bladder carcinoma (GBC).
Exploratory Objectives:
Analyze the biopsied tumor tissues for molecular profiling (by Caris Life Sciences, Inc ?) including genetic mutation in K-RAS, B-RAF, TP53, INK4A/p16, CDKN1A/p21 and RB by DNA sequencing, and expression of cyclin D.
Correlate the efficacy of abemaciclib with the mutational status of K-RAS, B-RAF, TP53, INK4A/p16, CDKN1A/p21, RB genes and expression of cyclin D.
Analyze the collected blood samples for characterization of extracellular vesicles (EVs).
