NCT01949545

Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment

An Open-Label, Single Arm, Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects With Advanced Malignancies and Varying Degrees of Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with varying degrees of liver function to see if they respond differently to the study drug.

Conditions

• Solid Tumors
• Hematologic Malignancies
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Carfilzomib	Carfilzomib was administered by IV injection over 30 minutes

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2013-09-24
• Last updated: 2017-05-02
• Results posted: 2016-10-21

Locations

11 sites across 4 countries: United States, France, Netherlands, United Kingdom