NCT04003896

A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma

A Pilot Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients With Advanced Biliary Tract Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Biliary Tract Carcinoma

Interventions

Type	Name	Description
DRUG	Abemaciclib	Participant will take 200 mg capsules or tablets orally twice daily. The participant will be instructed to swallow abemaciclib as a whole tablet and not to chew, crush or split capsules or tablets before swallowing. Participants should not ingest abemaciclib tablets if broken, cracked, or otherwise not intact. Doses should be taken at a approximately the same time every day, twice daily. Capsules or tablets can be taken orally with or without food. If the participant vomits or misses a dose of abemaciclib, the participant will be instructed to take the next dose at its scheduled time. Participants will also be provided with a diary and instructed to keep a twice daily record of the times they have taken their medications and any other events such as vomiting, diarrhea, etc.

Timeline

• Start date: 2021-09-24
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2019-07-01
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study