A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

Biliary Tract Carcinoma (BTC) is a leading cause of cancer-related mortality. The newly developed small molecule inhibitor of cyclin-dependent kinases (CDK4 and CDK6), abemaciclib, provides a new opportunity of treating patients with BTC. The goal of this clinical study is to determine the efficacy and safety of abemaciclib in patients with advanced or metastatic BTC that has progressed or intolerant to one or more lines of systemic therapy, or treatment-naïve subjects who either decline or being considered not a good candidate first-line systemic chemotherapy per the opinion of the treating physician. The investigator's objectives for this study are as follows: Primary Objectives: • To estimate the objective response rate (ORR) Secondary Objectives: - To determine progression free survival (PFS) - To determine the disease control rate (DCR) - To determine the overall survival (OS) rate at 6 and 12 months - To determine quality of life (QoL) using EORTC-QLQ-C30 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04003896
Study type	Interventional
Source	Milton S. Hershey Medical Center
Contact
Status	Terminated
Phase	Phase 2
Start date	September 24, 2021
Completion date	August 15, 2023

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See also
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